FIELD OF INVENTION
[0001] The present invention relates generally to apparatus for training, developing and
enhancing proprioceptive and kinesthetic skills, neuromuscular control and core stability.
BACKGROUND OF THE INVENTION
[0002] Proprioception refers to the ability to know where a body part is located in space
and to recognize movements of body parts (such as fingers and toes, feet and hands,
legs and arms). Kinesthesia is a related term, and refers to the sensation by which
position, weight, muscle tension and movement are perceived. In some of the medical
literature, proprioception refers to the conscious and unconscious appreciation of
joint position, while kinesthesia refers to the sensation of joint velocity and acceleration.
Proprioception is often used interchangeably with kinesthesia, and herein as well,
the terms will be used interchangeably. (Throughout the specification and claims,
the term "proprioception" will be used to encompass proprioception, kinesthesia, core
stability and the like.)
[0003] The neuromuscular control system of the body integrates peripheral sensations relative
to joint loads and processes these signals into coordinated motor responses. This
muscle activity serves to protect joint structures from excessive strain.
[0004] Certain mechanoreceptors are present throughout the soft tissues of the musculoskeletal
system which interact with the central nervous system and coordinate body movements,
postural alignment, and balance. Mechanoreceptors are located in the muscles, tendons,
ligaments, joint capsules and the skin. These nerve fibers provide information to
the brain regarding the status and function of the musculoskeletal system. The mechanoreceptors
send electrical signals along peripheral nerves to the spinal cord. The electrical
signals travel via the spinal cord to the brain where the signals are interpreted
to recognize movements of body parts, muscle tension, movement and the like.
[0005] Some examples of mechanoreceptors for controlling the muscular system include muscle
spindles. Muscle spindles are found interspersed within the contractile fibers of
skeletal muscles, with the highest concentration in the central portion of each muscle.
Muscle spindle fibers respond to changes in the length of muscles. These nerve endings
provide the central nervous system information used to maintain muscle tone and the
correct muscle tension on opposite sides of each joint.
[0006] Fibrous tissues that surround and protect most joints generally contain a variety
of sensory nerve endings for proprioception and kinesthesia. The input from these
sensory nerve endings provides the central nervous system information regarding the
location, stretch, compression, tension, acceleration, and rotation of the joint.
[0007] The foot is the anatomical region that contains the second largest number of proprioceptive
or kinesthetic sensory receptors in the body (the spine has the most).
[0008] Proprioceptive and kinesthetic exercises and exercise devices are well known for
improving agility, balance and coordination, and for rehabilitation of persons whose
proprioceptive ability has been impaired, such as after accidents or illness. One
such class of exercise devices includes tilt boards, wherein a patient stands on a
board or similar platform that has a ball mounted underneath. The board does not lie
horizontal due to the presence of the ball, and this challenges the ability of the
patient to balance and perform maneuvers on the platform. Repeated exercises on the
tilt board may be used to develop or rehabilitate the proprioception and neuromuscular
control of the patient, as well as strengthen muscles, tendons and connective tissues
in the foot area.
[0009] Other known proprioceptive and kinesthetic exercise devices include a shoe with a
single ball mounted underneath the sole of the shoe. The shoe with the ball is used
similar to the tilt board. Another kind of shoe has a rod mounted underneath the sole
of the shoe, used for strengthening dorsiflexor muscles.
[0010] Yet another proprioceptive and kinesthetic exercise device is described in
U.S. Pat. No. 6,283,897 to Patton. This device consists of one or more pegs protruding upwards from a baseboard. The
pegs have a rounded top and sit in concave depressions (divots) in the bottom of an
overshoe shaped like a sandal. Specifically, the bottom of the shoe's sole has three
concave, hemisphere-shaped divots, with one located within the heel portion, one directly
underneath the ball of the foot, and one located in the center. Elastomeric bands
may support the user's foot as the user turns his foot and/or hips to develop the
strength, range of motion, and proprioception of the ankle and hips.
SUMMARY OF THE INVENTION
[0011] There is thus provided, according to embodiments of the present invention, there
is provided footwear that includes a support member having an upper surface attachable
to a foot, and two bulbous protuberances, a forward bulbous protuberance and rearward
bulbous protuberance. Each of the protuberances has a curved outer contour, and protrudes
from a lower surface of the support member on opposite sides of a latitudinal midline.
The latitudinal midline is halfway between a calcaneus support portion and a phalanges
support portion of the support member. The forward bulbous protuberance is positioned
medially offset with respect to a longitudinal centerline and the rearward bulbous
protuberance is positioned laterally offset with respect to the longitudinal centerline.
[0012] Furthermore, according to embodiments of the present invention, the longitudinal
centerline is defined as a longitudinal straight line connecting middles of the short
sides of a rectangle which delimits a contour of the support member.
[0013] Furthermore, according to embodiments of the present invention, the contour is a
contour of a foothold confined by an upper part of the footwear.
[0014] Furthermore, according to embodiments of the present invention, the contour is an
outermost contour of the footwear.
[0015] Furthermore, according to embodiments of the present invention, the contour is the
contour of a bottom surface of a sole of the footwear.
[0016] Furthermore, according to embodiments of the present invention, the height of the
forward bulbous protuberance is greater than the height of the rearward bulbous protuberance.
[0017] Furthermore, according to embodiments of the present invention, the height of the
rearward bulbous protuberance is greater than the height of the forward bulbous protuberance.
[0018] Furthermore, according to embodiments of the present invention, there is provided
footwear that includes a support member having an upper surface attachable to a foot,
and two bulbous protuberances, a forward bulbous protuberance and rearward bulbous
protuberance. Each of the protuberances has a curved outer contour, and protrudes
from a lower surface of the support member on opposite sides of a latitudinal midline.
The forward bulbous protuberance is positioned laterally offset with respect to a
longitudinal centerline and the rearward bulbous protuberance is positioned medially
offset with respect to the longitudinal centerline.
[0019] Furthermore, according to embodiments of the present invention, there is provided
footwear that includes a support member having an upper surface attachable to a foot,
and two bulbous protuberances, a forward bulbous protuberance and rearward bulbous
protuberance. Each of the protuberances has a curved outer contour, and protrudes
from a lower surface of the support member on opposite sides of a latitudinal midline.
The height of the forward bulbous protuberance is greater than the height of the rearward
bulbous protuberance.
[0020] Furthermore, according to embodiments of the present invention, there is provided
footwear that includes a support member having an upper surface attachable to a foot,
and two bulbous protuberances, a forward bulbous protuberance and rearward bulbous
protuberance. Each of the protuberances has a curved outer contour, and protrudes
from a lower surface of the support member on opposite sides of a latitudinal midline.
The height of the rearward bulbous protuberance is greater than the height of the
forward bulbous protuberance.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The present invention will be understood and appreciated more fully from the following
detailed description taken in conjunction with the appended drawings in which:
FIG. 1 is a simplified pictorial illustration of footwear constructed and operative
in accordance with an embodiment of the present invention;
FIGS. 2 and 3 are simplified side-view and rear-view illustrations, respectively,
of the footwear of FIG. 1;
FIG. 4 is a simplified top-view illustration of the footwear of FIG. 1, showing further
features of other embodiments of the present invention;
FIG. 5 is a simplified pictorial illustration of a treadmill constructed and operative
in accordance with an embodiment of the present invention;
FIG. 6 is a simplified pictorial illustration of an exercise surface constructed and
operative in accordance with an embodiment of the present invention;
FIG. 7 is a simplified pictorial illustration of an exercise bicycle constructed and
operative in accordance with an embodiment of the present invention;
FIG. 8 is a simplified pictorial illustration of an exercise stepper constructed and
operative in accordance with an embodiment of the present invention;
FIG. 9 is a simplified pictorial illustration of a ski machine constructed and operative
in accordance with an embodiment of the present invention;
FIG. 10 is a simplified pictorial illustration of an elliptic exercise machine constructed
and operative in accordance with an embodiment of the present invention; and
FIG. 11 is a simplified pictorial illustration of a rowing machine constructed and
operative in accordance with an embodiment of the present invention.
FIG. 12 is a simplified pictorial illustration of an alignment of the anterior (forward)
and posterior (rearward) protuberances on a support member, according to embodiments
of the present invention.
FIG. 13 is a simplified pictorial illustration of another alignment of the anterior
and posterior protuberances on a support member, according to embodiments of the present
invention.
FIG. 14 is a simplified pictorial illustration of a sneaker constructed and operative
in accordance with an embodiment of the present invention, whose rearward protuberance
has a greater height than the height of the forward protuberance.
FIG. 15 is a simplified pictorial illustration of a sneaker constructed and operative
in accordance with an embodiment of the present invention, whose forward protuberance
has a greater height than the height of the rearward protuberance.
FIG. 16 illustrates maximal area boundaries of positioning of the anterior and posterior
protuberances with respect to a support surface, according to embodiments of the present
invention.
FIG. 17 illustrates effective area boundaries of positioning of the anterior and posterior
protuberances with respect to a support surface, according to embodiments of the present
invention.
FIG. 18A is an isometric view of a protuberance suitable for use on a footwear, according
to embodiments of the present invention.
FIG. 18B is a frontal view of a protuberance suitable for use on a footwear, according
to embodiments of the present invention.
FIG. 18C is a side view of a protuberance suitable for use on a footwear, according
to embodiments of the present invention.
FIG. 19 are graphs defining the convexity of a protuberance suitable for use on a
footwear, according to embodiments of the present invention. First graph 1000 illustrates
function
(1) and second graph 1002 illustrates function
The circumference of the protuberance is at x, y = 0 for both functions. The apex
of the protuberance is at x = m for both functions, whereas the y-axis value of the
apex may be between n1 for function (1) and n2 for function (2).
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0022] Reference is now made to FIGS. 1-4, which illustrate footwear 10 constructed and
operative in accordance with an embodiment of the present invention. Footwear 10 may
be supplied as one or more pairs of shoe-like devices, or alternatively, as just one
of the shoe-like devices.
[0023] Footwear 10 preferably comprises a support member 12 having a periphery in a shape
of a shoe sole with an upper surface 14. In the illustrated embodiment, the upper
surface 14 is indented with a peripheral ridge 16, but it is appreciated that other
configurations of upper surface 14 are within the scope of the invention. Footwear
10 may be attached to a foot of a user (not shown) by means of a boot 18 and/or fasteners
20, such as but not limited to, VELCRO straps, buckles, shoe laces, and the like.
Boot 18 may be fashioned for attachment to the user's foot with or without fasteners
20. Similarly, fasteners 20 may be used to attach footwear 10 to the user's foot without
boot 18.
[0024] In another embodiment, footwear comprises an inner sole (insole) and an outer sole.
In another embodiment, inner sole is equivalent to the maximal contour line defining
the representative footwear last or shoe last. In one embodiment, footwear is a shoe
or a pair of shoes.
[0025] In another embodiment, footwear comprises an outer sole (outsole). In another embodiment,
outer sole is the bordering contour line of a shoe surface facing the ground. In another
embodiment, outer sole is the layer facing the ground. In another embodiment, a protuberance's
base contacts the outer sole. In another embodiment, a spacer contacts the outer sole.
In another embodiment, a protuberance extends from the outer sole). In another embodiment,
outer sole is synonymous with "perimeter outer sole" or "the bordering contour line
of a shoe surface facing the ground" or "ground outer sole" or "the layer facing the
ground or "layer adapted to engage a ground surface".
[0026] Two bulbous protuberances 22 may protrude from a lower surface 24 of support member
12. Alternatively, bulbous protuberances 22 may protrude from the upper surface 14
of support member 12. Each protuberance 22 may have a curved outer contour 26. The
cross-section of the contour 26, that is, either the cross-section taken with respect
to a longitudinal axis 28 (FIG. 4) of support member 12 (corresponding to the shape
seen in FIG. 2) or the cross-section taken with respect to a latitudinal axis 30 (FIG.
4) of support member 12 (corresponding to the shape seen in FIG. 3), or any other
cross-section, may have any curvilinear shape. For example, the contours 26 may have
the shape of a conic section, that is, the shape of a circle, ellipse, parabola or
hyperbola. The various cross-sections of the contours 26 of protuberance 22 may be
shaped identically or differently.
[0027] As seen clearly in FIG. 2, one protuberance 22 may be positioned more posteriorly
than the other protuberance 22. As seen in FIG. 4, the protuberances may be positioned
on a common longitudinal axis of support member 12, such as the centerline 28 of support
member 12, and on opposite sides of the latitudinal midline 30. As seen in FIG. 2,
the rearward protuberance 22 may be positioned generally underneath a calcaneus (heel,
ankle) support portion 23 of support member 12, while the forward protuberance 22
may be positioned generally underneath a metatarsals support portion 25 and/or phalanges
support portion 27 of support member 12.
[0028] According to embodiments of the present invention, the longitudinal centerline is
defined as a longitudinal straight line connecting middles of the short sides of a
rectangle which delimits a contour of the support member.
[0029] Alternatively, as indicated by broken lines 33 in FIG. 4, one of the protuberances
22 (e.g., the forward one) may be aligned on a longitudinal axis 34 offset from centerline
28, and the rearward protuberance 22 may be positioned offset from axis 34, such as
on the centerline 28. It is appreciated that the above are just some examples of positioning
the protuberances 22, and many other possibilities exist within the scope of the invention.
[0030] The protuberances 22 may be constructed of any suitable material, such as but not
limited to, elastomers or metal or a combination of materials, and may have different
properties. For example, the protuberances may have different resilience or hardness,
such as having different elasticity properties or Shore hardness. The protuberances
22 may protrude by different amounts from the lower surface 24 of support member 12.
[0031] In accordance with an embodiment of the present invention, one or more protuberances
22 may be slidingly mounted on support member 12. For example, protuberance 22 may
be mounted on a track 36 (FIG. 2) formed in the lower surface 24 of support member
12, and may be selectively positioned anywhere along the track and fastened thereto.
Track 36 may extend along a portion of the shoe sole or all along the length of the
shoe sole. Alternatively or additionally, the amount of protrusion of protuberance
22 may be adjusted, such as by mounting protuberance 22 with a threaded fastener 38
(FIG. 3) to support member 12 and tightening or releasing threaded fastener 38.
[0032] In accordance with an embodiment of the present invention, in addition to the bulbous
protuberances 22, there further may be provided one or more non-bulbous protuberances
39, shown in FIG. 3. Protuberances 39 may be formed in the shape of a peg, stud, bolt,
pin, dowel and the like, although the invention is not limited to these shapes. Protuberances
39 may be rigid or flexible. As with protuberances 22, the protuberances 39 may have
different resilience or hardness, such as having different elasticity properties or
Shore hardness, and they may protrude by different amounts from the lower surface
24 of support member 12. As above, the amount of protrusion of protuberances 39 may
be adjusted. Protuberances 39 may be mounted at any place on the lower surface 24
of support member 12.
[0033] The features described above, such as the protuberances 22 being slidingly mounted
on support member 12, may be implemented in the alternative embodiment wherein the
bulbous protuberances 22 protrude from the upper surface 14 of support member 12.
For example, footwear 10 may have a normal outer sole and have a sliding/shifting
mechanism for the protuberances 22 inside the sole of footwear 10. The sliding/shifting
mechanism may comprise, without limitation, a mechanism that floats in a viscous matrix
(e.g., fluid in a chamber formed in the sole) or that is suspended by inner cables.
[0034] Reference is now made to FIG. 4. In accordance with an embodiment of the present
invention, footwear 10 may comprise a flange 40 that extends outwards from the periphery
of support member 12. In the illustrated embodiment, flange 40 extends sideways outwards
from the periphery of support member 12, but it is appreciated that flange 40 may
extend forwards or rearwards or in any other direction as well. Flange 40 may be provided
on one side of footwear 10, as illustrated, or may be provided on both sides. Flange
40 may supplement the range of proprioceptive exercises possible with footwear 10,
by providing an additional support surface during tilting and maneuvering with footwear
10.
[0035] Flange 40 may be constructed of any suitable material, such as but not limited to,
elastomers or metal or a combination of materials, and may have portions 42 with different
properties. For example, portions 42 may have different resilience or hardness, such
as having different elasticity properties or Shore hardness. The portions 42 of flange
40 may have differently curved contours. Flange 40 may be adjustably attached to support
member 12 such that the amount that flange 40 extends from support member 12 is adjustable.
[0036] A user may attach footwear 10 to his/her foot and perform a variety of maneuvers
in a proprioceptive and/or kinesthetic exercise plan for the lower foot, upper leg
and even upper torso and other body parts and organs. For example, footwear 10 may
be used to reestablish neuromuscular control during rehabilitation of joints, to restore
the mechanical and functional stability of the neuromuscular system, to improve or
rehabilitate anticipatory (feed-forward) and reflexive (feed-back) neuromuscular control
mechanism, and to regain and improve balance, postural equilibrium and core stability.
[0037] Reference is now made to FIG. 5, which illustrates a treadmill 50 constructed and
operative in accordance with an embodiment of the present invention.
[0038] Treadmill 50 may comprise a foot-contact running surface 52 that rotates about a
pair of spaced pulleys 54. Running surface 52 may comprise one or more protuberances
56 protruding upwards from running surface 52. Protuberances 56 may be of different
or similar configuration (e.g., height, size, shape and/or slope). Protuberances 56
may have a fixed size/shape, or alternatively, may have a variable size/shape. The
variable size/shape may be achieved by constructing protuberance 56 from an inflatable
element, which may be inflated pneumatically with air or hydraulically with a liquid
(e.g., water or oil). A controller 58 may be provided that controls inflation and
deflation of protuberances 56. Protuberances 56 and/or running surface 52 may have
different or similar material properties. For example, they may have different or
similar resilience or viscosity (in the inflatable version) and may be made of different
or similar materials.
[0039] Protuberances 56 may be movable. For example, one or more of the protuberances 56
may be translatable such as in a track 57 (e.g., forwards, backwards, sideways or
diagonally) and/or rotatable about its own or other axis, or a combination of such
motions. A protective strap
[0040] (not shown) may be provided to maintain the user in an upright position and help
prevent accidental falls.
[0041] Reference is now made to FIG. 6, which illustrates an exercise surface 60 constructed
and operative in accordance with an embodiment of the present invention. Exercise
surface 60 may comprise one or more protuberances 62 protruding upwards from the upper
(foot-contacting) face and/or lower (floor-contacting) face of exercise surface 60.
Protuberances 62 may be of different or similar configuration (e.g., height, size,
shape and/or slope). Protuberances 62 may have a fixed size/shape, or alternatively,
may have a variable size/shape. The variable size/shape may be achieved by constructing
protuberance 62 from an inflatable element, which may be inflated pneumatically with
air or hydraulically with a liquid (e.g., water or oil). A controller 64 may be provided
that controls inflation and deflation of protuberances 62. Protuberances 62 may have
different or similar resilience or viscosity (in the inflatable version), and may
be made of different or similar materials.
[0042] Protuberances 62 may be movable. For example, one or more of the protuberances 62
may be translatable such as in a track 66 (e.g., forwards, backwards, sideways, radially
or diagonally) and/or rotatable about its own or other axis, or a combination of such
motions. A user of the exercise surface 60 may thus move in six degrees of freedom
(translating in three mutually orthogonal directions (x, y, z) and rotating about
these axes (azimuth, elevation and roll)).
[0043] Reference is now made to FIG. 7, which illustrates a stationary exercise bicycle
70 constructed and operative in accordance with an embodiment of the present invention.
Exercise bicycle 70 may comprise apparatus with its own pedals, wheel and sensors
(e.g., speedometer, odometer, etc.) or may comprise an indoor bicycle trainer, wherein
a user mounts a bicycle to a stand, which permits pedaling the bicycle while the bicycle
remains stationary. Exercise bicycle 70 may comprise a bumping mechanism 72 connected
to a front axle 74 or rear support 75 of bicycle 70 and/or a bumping mechanism 76
connected to a seat 78 of bicycle 70. The bumping mechanisms may oscillate, rock,
bump and otherwise disrupt the balance of the user of the exercise bicycle 70 (as
indicated by arrows in FIG. 7). The bumping mechanisms may move the rider in six degrees
of freedom (translation in three mutually orthogonal directions (x, y, z) and rotation
about these axes (azimuth, elevation and roll)). The bumping mechanisms in this embodiment,
as in other embodiments of the invention, may comprise a plate on which exercise bicycle
70 is mounted, wherein the plate provides the bumping action in six degrees of freedom.
[0044] Exercise bicycle 70 may be used to exercise the neuromuscular control in the back,
hip, pelvis, ankle, knee and other parts of the body by means of bumps during riding,
which may simulate riding on bumpy roads. A controller 77 may be provided to control
operation of bumping mechanism 72.
[0045] Reference is now made to FIG. 8, which illustrates an exercise stepper 80, constructed
and operative in accordance with an embodiment of the present invention. Exercise
stepper 80 may comprise a controller 82 that varies the resistive force offered by
pedals 84 of the stepper 80. Controller 82 may also vary the angle of the pedals 84,
such as to create eversion and inversion, as indicated by arrows in FIG. 8. Here too,
controller 82 may move the pedals 84 in six degrees of freedom (translation in three
mutually orthogonal directions (x, y, z) and rotation about these axes (azimuth, elevation
and roll)).
[0046] Reference is now made to FIG. 9, which illustrates a ski machine 90, constructed
and operative in accordance with an embodiment of the present invention. Ski machine
90 may comprise a controller 92 that varies the resistive force offered by ski platforms
94 of the ski 90. Controller 92 may also vary the angle of ski platforms 94, such
as to create eversion and inversion, as indicated by arrows in FIG. 9. Controller
92 may move the ski platforms 94 in six degrees of freedom (translation in three mutually
orthogonal directions (x, y, z) and rotation about these axes (azimuth, elevation
and roll)).
[0047] Some exercise experts have noted several drawbacks to prior art exercise equipment.
For example, stationary exercise bicycles may utilize only a relatively small number
of muscles, throughout a fairly limited range of motion. Cross-country skiing devices
may exercise more muscles than a stationary bicycle, however, the substantially flat
shuffling foot motion of the device may limit the range of motion of some of the muscles
being exercised. Stair climbing devices may exercise more muscles than stationary
bicycles, however, the limited range of up-and-down motion may not exercise the leg
muscles through a large range of motion.
[0048] In response to these concerns, elliptic exercise machines have been developed that
simulate natural walking and running motions and exercise a large number of muscles
through a large range of motion. The machines provide variable, flexibly coordinated
elliptical motion of the leg muscles. An example of one of the many elliptic exercise
machines in the prior art is described in
U.S. Pat. No. 5,848,954.
[0049] Reference is now made to FIG. 10, which illustrates an elliptic exercise machine
100, constructed and operative in accordance with an embodiment of the present invention.
Elliptic exercise machine 100 is shown for convenience with some elements similar
to that of
U.S. Pat. No. 5,848,954, but it is emphasized that the invention is not limited to this construction. In
any case, the proprioceptive features of the invention are not found in
U.S. Pat. No. 5,848,954 or any of the prior art.
[0050] Elliptic exercise machine 100 may comprise a frame 102 and a linkage assembly 104
movably mounted on frame 102. Linkage assembly 104 may generally move relative to
frame 102 in a manner that links rotation of a flywheel 106 to generally elliptical
motion of a force receiving member or "skate" 108. Frame 102 may include a base 110,
a forward stanchion or upright 112, and a rearward stanchion or upright 114.
[0051] It is noted that the term "elliptical motion" is intended in a broad sense to describe
a closed path of motion having a relatively longer first axis and a relatively shorter
second axis (which extends perpendicular to the first axis). It is further noted that
in the illustrated embodiment, there is left-right symmetry about a longitudinal axis,
and the "right-hand" components are 180.degree out of phase relative to the "left-hand"
components. However, like reference numerals are used to designate both the "right-hand"
and "left-hand" parts on elliptic exercise machine 100, and when reference is made
to one or more parts on only one side of the machine, it is to be understood that
corresponding part(s) are disposed on the opposite side of the machine.
[0052] The forward stanchion 112 may extend perpendicularly upward from base 110 and support
a telescoping tube or post 116. A pair of handles 118 may be pivotally mounted to
post 116 at a pivot 119. Handles 118 may have gripping portions 120. A display 122
may be disposed on post 116. Skates 108 may slide on rails 124. A user may place his/her
foot on a foot-contacting surface 126 of skate 108.
[0053] In accordance with an embodiment of the present invention, elliptic exercise machine
100 may comprise one or more bumping mechanisms 130 connected to a front support 132
and/or a rear support 134 of rails 124. The bumping mechanisms 130 may oscillate,
rock, bump and otherwise disrupt the balance of the user of elliptic exercise machine
100. The bumping mechanisms 130 may move the user in six degrees of freedom (translation
in three mutually orthogonal directions (x, y, z) and rotation about these axes (azimuth,
elevation and roll)). A controller 136 may be provided to control operation of bumping
mechanism 130.
[0054] Reference is now made to FIG. 11, which illustrates a rowing machine 150, constructed
and operative in accordance with an embodiment of the present invention. Rowing machine
150 may comprise a rail 152 on which a seat 154 is slidingly mounted. Rail 152 may
have a rear support 155. Rail 152 may extend from a forward-mounted tension drum 156,
which may be mounted on a front support 157. A cord 158 may be wound around tension
drum 156. Cord 158 may be provided with a handle 159. Footrests 160 may be mounted
on rail 152.
[0055] A user (not shown) may sit on seat 154, place feet against the footrests 160, grasp
handle 159 and pull cord 158 towards the rear of rowing machine 150, outwards from
tension drum 156. This motion simulates the action of pulling oars in a rowboat. The
seat 154 may slide back and forth on rail 152 during the rowing motion. Tension drum
156 resists the pulling action on cord 158, thereby exercising muscles used in rowing.
The tension in tension drum 156 may be adjusted to suit the desired level of exercise.
A controller 162 may be provided that varies the resistive force offered by tension
drum 156.
[0056] In accordance with an embodiment of the present invention, rowing machine 150 may
comprise one or more bumping mechanisms 164 connected to front support 157 and/or
rear support 155 of rail 152, or to seat 154. The bumping mechanisms 164 may oscillate,
rock, bump and otherwise disrupt the balance of the user of rowing machine 150. The
bumping mechanisms 164 may move the user in six degrees of freedom (translation in
three mutually orthogonal directions (x, y, z) and rotation about these axes (azimuth,
elevation and roll)). Controller 162 may control operation of bumping mechanisms 164.
[0057] In some embodiments of the present invention, at least two bulbous protuberances
22 protrude from a lower surface 24 of support member 12. In some embodiments of the
present invention, only two bulbous protuberances 22 protrude from a lower surface
24 of support member 12. In some embodiments of the present invention, a lower surface
of support member is an outsole. In some embodiments of the present invention, only
two bulbous protuberances 22 protrude from a lower surface 24 of support member 12.
In some embodiments of the present invention, the ground engaging parts of the device
are only the bulbous protuberances 22. In some embodiments of the present invention,
during all phases of gait including the stance phase the bulbous protuberances 22
are the only parts of the device which are ground engaging. In some embodiments of
the present invention, during all phases of gait including the stance phase the bulbous
protuberances 22 are the only parts of the device which are in direct contact with
the ground.
[0058] In another embodiment, protuberances as described herein are not pegs. In another
embodiment, each shoe of the footwear of the invention comprises two bulbous protuberances.
In another embodiment, each shoe of the footwear of the invention consists two bulbous
protuberances. In another embodiment, each shoe of the footwear of the invention consists
two bulbous protuberances and optionally spacers/weights places in between a protuberance's
base and the outer-sole.
[0059] In another embodiment, the invention provides that the device such as footwear 10
supports the foot of a subject only by the two protuberances when the two protuberances
are placed on a ground surface. In another embodiment, the invention provides that
the device such as footwear 10 supports the foot of a subject during stance by only
two protuberances when the two protuberances are placed on a ground surface. In another
embodiment, the invention provides that during stance only the 2 ground engaging surfaces
of the protuberances (such as the peak or the surface facing the ground) are in contact
with a ground surface. In another embodiment, the invention provides that during stance
only the ground engaging surface in each protuberance is in contact with a ground
surface. Each possibility represents a separate embodiment of the present invention.
[0060] In another embodiment, at least two bulbous protuberances 22 protrude from a lower
surface 24 of support member 12. In another embodiment, only two bulbous protuberances
22 protrude from a lower surface 24 of support member 12.
[0061] In another embodiment, the outer sole is a surface having no openings or apertures
adapted to receive additional protuberances other than the two bulbous protuberances
22. In another embodiment, the outer sole is a surface having no protrusions other
than the two bulbous protuberances 22.
[0062] In some embodiments of the present invention, a protuberance as described herein
is movable. In some embodiments of the present invention, a protuberance as described
herein is mountable. In some embodiments of the present invention, a protuberance
as described herein is replaceable. In some embodiments of the present invention,
a protuberance as described herein is movable along the outer surface of the support
member. In some embodiments of the present invention, a protuberance as described
herein is movable along the outer surface of the outsole. In some embodiments of the
present invention, a protuberance as described herein can be positioned within the
outer surface of the support member.
[0063] In some embodiments of the present invention a protuberance is fixed in a predetermined
location. In some embodiments of the present invention, a protuberance is movable
within a predefined area. In some embodiments of the present invention, a protuberance
is movable within an area of 1 cm2 to 18 cm2. In some embodiments of the present invention,
a protuberance is movable within an area of 1 cm2 to 6 cm2. In some embodiments of
the present invention, a protuberance is movable within an area of 1 cm2 to 4 cm2.
In some embodiments of the present invention, a protuberance is movable within an
area of 2 cm2 to 8 cm2. In some embodiments of the present invention, a protuberance
is movable within an area of 3 cm2 to 6 cm2. In some embodiments of the present invention,
a protuberance is movable within an area of 4 cm2 to 10 cm2. In some embodiments of
the present invention, a protuberance is movable within an area of 5 cm2 to 18 cm2.
In some embodiments of the present invention, a protuberance is movable within an
area of 4 cm2 to 12 cm2.
[0064] In some embodiments of the present invention, the predefined area within which the
protuberance is movable is a circle. In other embodiments, a predefined area within
which the protuberance is movable is a square. In other embodiments, a predefined
area within which the protuberance is movable is an ellipse. In other embodiments,
a predefined area within which the protuberance is movable is a rectangle. In other
embodiments, a predefined area within which the protuberance is movable is quadrangular.
[0065] In some embodiments, the protuberance is hooked to a rail. In some embodiments, the
protuberance is connected to a rail. In some embodiments, the protuberance is connected
to a rail and is movable along the rail. In some embodiments, the protuberance is
connected to a rail, is movable along the rail, and can be positioned and/or fixed
anywhere along the rail.
[0066] [In another embodiment, a protuberance can be fixed anywhere on the support member.
In another embodiment, a protuberance can be positioned and/or fixed anywhere within
a predefined area.
[0067] In another embodiment, the device comprises at least one anterior protuberance and
one moveable/relocatable posterior protuberance. In another embodiment, the device
comprises at least one moveable/relocatable anterior protuberance and one posterior
protuberance. In another embodiment, the device comprises one moveable/relocatable
anterior protuberance and one moveable/relocatable posterior protuberance. In another
embodiment, the device consists one moveable/relocatable anterior protuberance and
one moveable/relocatable posterior protuberance. Each possibility represents a separate
embodiment of the present invention. In another embodiment, the term "comprises" may
include the term "consists".
[0068] As seen clearly in FIG. 2, one protuberance 22 may be positioned more posteriorly
than the other protuberance 22. In some embodiments, a device as described herein
comprises at least one anterior bulbous protuberance. In other embodiments, a device
as described herein comprises at least one posterior bulbous protuberance. In other
embodiments, the device includes one anterior bulbous protuberance and one posterior
bulbous protuberance. In other embodiments, the device comprises at least one anterior
bulbous protuberance and one moveable posterior bulbous protuberance. In other embodiments,
the device comprises at least one moveable anterior bulbous protuberance and one posterior
bulbous protuberance. In other embodiments, the device comprises at least one moveable
anterior bulbous protuberance and one moveable posterior bulbous protuberance. In
other embodiments, the device includes one moveable anterior bulbous protuberance
and one moveable posterior bulbous protuberance.
[0069] The longitudinal centerline is defined, in some embodiments, as a longitudinal straight
line connecting middles of the short sides of a rectangle which delimits a contour
of the support member. The contour of the support member is defined, in some embodiments,
as a foothold confined by an upper part of the footwear. The contour of the support
member is defined, in some embodiments, as an outermost contour of the footwear. The
contour of the support member is defined, in some embodiments, as a contour of a bottom
surface of a sole of the footwear.
[0070] In some embodiments, the protuberances rise vertically, each protuberance including
a base end and a peak end. In some embodiments, the surface area of the base is larger
than the surface area of the peak. In some embodiments, the peak is the ground engaging
portion of a protuberance.
[0071] In some embodiments, bulbous protuberance 22 protrudes from the upper surface 14
of support member 12. In some embodiments, each protuberance 22 has a curved outer
contour 26. In some embodiments, each protuberance 22 has a different curved outer
contour. In some embodiments, each protuberance 22 has a convexity. In some embodiments,
each protuberance 22 has a different convexity. The cross-section of the contour 26,
that is, either the cross-section taken with respect to a longitudinal axis 28 (FIG.
4) of support member 12 (corresponding to the shape seen in FIG. 2) or the cross-section
taken with respect to a latitudinal axis 30 (FIG. 4) of support member 12 (corresponding
to the shape seen in FIG. 3), or any other cross-section, may have any curvilinear
shape. In some embodiments, the contours 26 may have the shape of a conic section,
that is, the shape of a circle, ellipse, parabola or hyperbola. The various cross-sections
of the contours 26 of protuberance 22 may be shaped identically or differently.
[0072] In some embodiments, as seen in FIG. 4, the protuberances are positioned on a common
longitudinal axis of support member 12, such as the centerline 28 of support member
12. In some embodiments, the protuberances are positioned on opposite sides of the
latitudinal midline 30. In some embodiments, the protuberances are positioned offset
from the centerline 28 of support member 12, and on opposite sides of the latitudinal
midline 30. In some embodiments, the meaning of "protuberance is positioned offset
from the centerline" comprises that the peak or the ground engaging surface of a protuberances
is positioned offset from the centerline. In some embodiments, the meaning of "protuberance
is positioned offset from the centerline" comprises that only the peak or the ground
engaging surface of a protuberances is positioned offset from the centerline but the
centerline still crosses the protuberance. In some embodiments, the bases of the protuberances
are positioned on the centerline of the support member. In some embodiments, the peaks
of the protuberances are positioned on opposite sides of the centerline of support
member. In some embodiments, the centerline divides longitudinally the calcaneus support
portion into two equal halves and further extends towards the phalanges and metatarsals
support portion in a straight line. In some embodiments, the centerline divides longitudinally
the arch of the calcaneus support portion into two equal halves and further extends
towards the phalanges and metatarsals support portion in a straight line. In some
embodiments, the centerline divides longitudinally the proximal arch of the calcaneus
support portion into two equal halves and further extends towards the phalanges and
metatarsals support portion in a straight line. In some embodiments, the centerline
divides longitudinally the support portion as seen in FIG. 4 of the calcaneus support
portion into two equal halves and further extends towards the phalanges and metatarsals
support portion in a straight line.
[0073] In some embodiments, the bases of the protuberances are positioned on the centerline
of the support member and the peaks of the protuberances are positioned on opposite
sides of the centerline of support member. In some embodiments, the bases of the protuberances
are positioned on the centerline of the support member but the peaks of the protuberances
are offset from the centerline of the support member. In some embodiments, the bases
of the protuberances are positioned on the centerline of the support member but the
peaks of the protuberances are positioned on opposite sides of the centerline of the
support member.
[0074] In some embodiments, the anterior protuberance is positioned medially from the centerline
of the support member. In some embodiments, the peak of the anterior protuberance
is positioned medially from the centerline of the support member. In some embodiments,
the base of the anterior protuberance is position on the centerline of the support
member but the peak of the anterior protuberance is positioned medially from the centerline
of the support member. In some embodiments, the anterior protuberance is positioned
laterally from the centerline of the support member. In some embodiments, the peak
of the anterior protuberance is positioned laterally from the centerline of the support
member. In some embodiments, the base of the anterior protuberance is position on
the centerline of the support member but the peak of the anterior protuberance is
positioned laterally from the centerline of the support member. In some embodiments,
the posterior protuberance is positioned medially from the centerline of the support
member. In some embodiments, the peak of the posterior protuberance is positioned
medially from the centerline of the support member. In some embodiments, the base
of the posterior protuberance is positioned on the centerline of the support member
but the peak of the posterior protuberance is positioned medially from the centerline
of the support member. In some embodiments, the posterior protuberance is positioned
laterally from the centerline of the support member. In some embodiments, the peak
of the posterior protuberance is positioned laterally from the centerline of the support
member. In some embodiments, the base of the posterior protuberance is position on
the centerline of the support member but the peak of the posterior protuberance is
positioned laterally from the centerline of the support member.
[0075] In some embodiments, the term sneaker comprises a boot. In some embodiments, the
term sneaker comprises a walking boot. In some embodiments, sneaker comprises a platform
of a running shoe.
[0076] In some embodiments, the ground engaging parts of the device are only the protuberances.
In some embodiments, during all phases of gait including the stance phase the protuberances
are the only parts of the device which are ground engaging. In some embodiments, during
the stance phase the protuberances are the only parts of the device which are ground
engaging. Each possibility represents a separate embodiment of the present invention.
[0077] In some embodiments, a protuberance is movable within a predefined area. In some
embodiments, a protuberance is movable within an area of 1 cm2 to 18 cm2. In some
embodiments, a protuberance is movable within an area of 1 cm2 to 6 cm2. In some embodiments,
a protuberance is movable within an area of 1 cm2 to 4 cm2. In some embodiments, a
protuberance is movable within an area of 2 cm2 to 8 cm2. In some embodiments, a protuberance
is movable within an area of 3 cm2 to 6 cm2. In some embodiments, a protuberance is
movable within an area of 4 cm2 to 10 cm2. In some embodiments, a protuberance is
movable within an area of 5 cm2 to 18 cm2. In some embodiments, a protuberance is
movable within an area of 4 cm2 to 12 cm2. Each possibility represents a separate
embodiment of the present invention.
[0078] In some embodiments, the footwear 10 comprises a support member 12 having a periphery
in a shape of a shoe sole with an upper surface 14. In some embodiments, the footwear
10 comprises an insole placed on top of the upper surface 14. In some embodiments,
the insole is the interior bottom of footwear 10. In some embodiments, the insole
sits directly beneath the foot. In some embodiments, the insole is removable, replaceable,
or both. In some embodiments, the insole adds comfort, control the shape, moisture,
smell, or any combination thereof. In some embodiments, the insole is placed to correct
defects in the natural shape of the foot or positioning of the foot during standing
or walking. Each possibility represents a separate embodiment of the present invention.
[0079] In some embodiments, the peak or the ground engaging surface of the anterior protuberance
is positioned laterally from the centerline of the support member. In some embodiments,
the peak or the ground engaging surface of the anterior protuberance is positioned
medially from the centerline of the support member. In some embodiments, the peak
or the ground engaging surface of the anterior protuberance is positioned laterally
from the centerline of the support member and the peak or the ground engaging surface
of the posterior protuberance is aligned with centerline. In some embodiments, the
peak or the ground engaging surface of the anterior protuberance is positioned medially
from the centerline of the support member and the peak or the ground engaging surface
of the posterior protuberance is aligned with centerline. Each possibility represents
a separate embodiment of the present invention.
[0080] In some embodiments, the peak or the ground engaging surface of the posterior protuberance
is positioned laterally from the centerline of the support member. In some embodiments,
the peak or the ground engaging surface of the posterior protuberance is positioned
medially from the centerline of the support member. In some embodiments, the peak
or the ground engaging surface of the posterior protuberance is positioned laterally
from the centerline of the support member and the peak or the ground engaging surface
of the anterior protuberance is aligned with centerline. In some embodiments, the
peak or the ground engaging surface of the posterior protuberance is positioned medially
from the centerline of the support member and the peak or the ground engaging surface
of the anterior protuberance is aligned with centerline. Each possibility represents
a separate embodiment of the present invention.
[0081] In some embodiments, the peak or the ground engaging surface of the posterior protuberance
is positioned laterally from the centerline of the support member and the peak or
the ground engaging surface of the anterior protuberance is positioned medially from
the centerline of the support member. In some embodiments, the peak or the ground
engaging surface of the anterior protuberance is positioned laterally from the centerline
of the support member and the peak or the ground engaging surface of the posterior
protuberance is positioned medially from the centerline of the support member. Each
possibility represents a separate embodiment of the present invention.
[0082] In some embodiments, protuberances are of different heights. In some embodiments,
protuberances are of different weights. In some embodiments, a footwear of the invention
further comprises a spacer located between the base of a protuberance and the support
member or outsole. In some embodiments, a spacer is used for adjusting the height
of a protuberance, the weight of a protuberance or a combination thereof.
[0083] In some embodiments, a spacer or a protuberance comprises a diameter of 50-150 mm.
In some embodiments, a spacer or a protuberance comprises a diameter of 55-110 mm.
In some embodiments, a spacer or a protuberance comprises a diameter of 60-100 mm.
In some embodiments, a spacer or a protuberance comprises a diameter of 80-90 mm.
In some embodiments, a spacer or a protuberance comprises a diameter of 85 mm. In
some embodiments, a spacer or a protuberance or a protuberance comprises a thickness
of 1-12 mm. In some embodiments, a spacer or a protuberance comprises a thickness
of 1-4 mm. In some embodiments, a spacer or a protuberance comprises a thickness of
3-10 mm. In some embodiments, a spacer or a protuberance comprises a thickness of
1-3 mm.
[0084] In some embodiments, a spacer or a protuberance comprises hardness of 35-100 Sh A.
In some embodiments, a spacer or a protuberance comprises hardness of 60-70 Shore
A, which is a soft spacer. In some embodiments, a spacer or a protuberance comprises
hardness of 90-100 Shore A, which is a hard spacer. In some embodiments, a spacer
or a protuberance comprises hardness of 70-90 Shore A, which is medium hardness spacer.
In another embodiment, the protuberance's range of hardness as provided herein reflects
an effective range that allows minimal deformation of the protuberance's structure/shape/contour.
In another embodiment, the protuberance's range of hardness reflects an effective
range that abolishes or minimizes bouncing. In another embodiment, the protuberance's
range of hardness reflects an effective range that abolishes or minimizes spring characteristics.
In another embodiment, the protuberance's range of hardness reflects an effective
range that allows optimal and/or minimizes bouncing. In another embodiment, the protuberance's
range of hardness enables the control of ground reaction force. In another embodiment,
the protuberance's range of hardness enables the control of ground reaction force
which is important for treating osteoarthritis. In another embodiment, the protuberance's
range of hardness enables the control of ground reaction force which is important
for treating knee pathologies such as knee osteoarthritis. In another embodiment,
a hard protuberance focuses, concentrates and/or enhances loads exerted on it while
a soft protuberance allows the migration of loads. In another embodiment, a "hard"
protuberance has shore hardness in the upper 40% of the range of shore hardness provided
herein. In another embodiment, a "soft" protuberance has shore hardness in the lower
40% of the range of shore hardness provided herein.
[0085] In another embodiment, the harder the protuberance is, the vectorial shift of loads
exerted by the user on the protuberance during gait, is more precise with respect
to [targeted] body part. In another embodiment, a hard protuberance minimizes deformation
of the protuberance upon impact with the ground, especially in the area contacting
the ground. In another embodiment, the softer protuberance reduces the impact resulting
from ground engagement. In another embodiment, the soft protuberance has better shock
absorbing properties than the hard protuberance and is suited for the treatment of
pain in the lower limbs and/or lower back.
[0086] In another embodiment, a protuberance is a soft protuberance comprising a shore hardness
of between 40 to 55 Sh A. In another embodiment, a protuberance is a medium hardness
protuberance comprising a shore hardness of between 50 to 70 Sh A. In another embodiment,
a protuberance is a hard protuberance comprising a shore hardness of between 65 to
90 Sh A.
[0087] In some embodiments, a spacer or a protuberance weighs 2-500 g. In some embodiments,
a spacer or a protuberance weighs 2-250 g. In some embodiments, a spacer or a protuberance
weighs 2-6 g. In some embodiments, a spacer or a protuberance weighs 2-20 g. In some
embodiments, a spacer or a protuberance weighs 2-20 g is made of Nylon. In some embodiments,
a spacer or a protuberance weighs 2-20 g is made of Nylon and fiber. In some embodiments,
a spacer or a protuberance weighs 2-40 g is made of Nylon and glass fiber. In some
embodiments, a spacer or a protuberance weighs 30-100 g. In some embodiments, a spacer
or a protuberance weighs 50-80 g. In some embodiments, a spacer or a protuberance
weighs 60-100 g. In some embodiments, a spacer or a protuberance comprises: Nylon
glass fiber polyurethane an alloy (such as but not limited to Zink alloy), or any
combination thereof. Each possibility represents a separate embodiment of the present
invention.
[0088] In another embodiment, the ratio between the surface area of the inner sole (the
surface are facing the user's foot or the surface area adapted to contact the user's
foot) to the combined surface area of the bases of the two bulbous protuberances is
7:1 to 1:0.8. In another embodiment, the ratio between the surface area of the inner
sole to the combined surface area of the bases of the two bulbous protuberances is
5:1 to 1:1. In another embodiment, the ratio between the surface area of the inner
sole to the combined surface area of the bases of the two bulbous protuberances is
4:1 to 1:1. In another embodiment, the ratio between the surface area of the inner
sole to the combined surface area of the bases of the two bulbous protuberances is
6:1 to 2:1. In another embodiment, the ratio between the surface area of the inner
sole to the combined surface area of the bases of the two bulbous protuberances is
8:1 to 1:1. In another embodiment, the ratio between the surface area of the inner
sole to the combined surface area of the bases of the two bulbous protuberances is
6:1 to 1:1.5. In another embodiment, the ratio between the surface area of the inner
sole to the combined surface area of the bases of the two bulbous protuberances is
8:1 to 3:1.
[0089] In another embodiment, the ratio between the surface area of the inner sole (the
surface is facing the user's foot or the surface area adapted to contact the user's
foot) to the surface area of a base of at least one bulbous protuberance of the two
bulbous protuberances is 20:1 to 4:1. In another embodiment, the ratio between the
surface area of the inner sole to the surface area of a base of at least one bulbous
protuberance of the two bulbous protuberances is 15:1 to 3:1. In another embodiment,
the ratio between the surface area of the inner sole to the surface area of a base
of at least one bulbous protuberance of the two bulbous protuberances is 12:1 to 5:1.
In another embodiment, the ratio between the surface area of the inner sole to the
surface area of a base of at least one bulbous protuberance of the two bulbous protuberances
is 8:1 to 3:1. In another embodiment, the ratio between the surface area of the inner
sole to the surface area of a base of at least one bulbous protuberance of the two
bulbous protuberances is 6:1 to 2:1.In another embodiment, the ratio between the surface
area of the inner sole to the surface area of a base of at least one bulbous protuberance
of the two bulbous protuberances is less than 20:1. In another embodiment, the ratio
between the surface area of the inner sole to the surface area of a base of at least
one bulbous protuberance of the two bulbous protuberances is less than 15:1. In another
embodiment, the ratio between the surface area of the inner sole to the surface area
of a base of at least one bulbous protuberance of the two bulbous protuberances is
less than 12:1. In another embodiment, the ratio between the surface area of the inner
sole to the surface area of a base of at least one bulbous protuberance of the two
bulbous protuberances is less than 10:1. In another embodiment, the ratio between
the surface area of the inner sole to the surface area of a base of at least one bulbous
protuberance of the two bulbous protuberances is less than 8: 1.. In another embodiment,
the ratio between the surface area of the inner sole to the surface area of a base
of at least one bulbous protuberance of the two bulbous protuberances is less than
7: 1.. In another embodiment, the ratio between the surface area of the inner sole
to the surface area of a base of at least one bulbous protuberance of the two bulbous
protuberances is less than 6: 1.. In another embodiment, the ratio between the surface
area of the inner sole to the surface area of a base of at least one bulbous protuberance
of the two bulbous protuberances is less than 5: 1.. In another embodiment, the ratio
between the surface area of the inner sole to the surface area of a base of at least
one bulbous protuberance of the two bulbous protuberances is less than 4:1.
[0090] In another embodiment, the ratio between the surface area of the inner sole to the
surface area of a base of at least one bulbous protuberance of the two bulbous protuberances
is more than 1:1. In another embodiment, the ratio between the surface area of the
inner sole to the surface area of a base of at least one bulbous protuberance of the
two bulbous protuberances is more than 1.5:1. In another embodiment, the ratio between
the surface area of the inner sole to the surface area of a base of at least one bulbous
protuberance of the two bulbous protuberances is more than 2:1. In another embodiment,
the ratio between the surface area of the inner sole to the surface area of a base
of at least one bulbous protuberance of the two bulbous protuberances is more than
3:1.
[0091] In another embodiment, the ratio between the surface area of the outer sole (the
surface are facing the ground) to the combined surface area of the bases of the two
bulbous protuberances is 20:1 to 4:1. In another embodiment, the ratio between the
surface area of the outer sole to the combined surface area of the bases of the two
bulbous protuberances is 1:16 to 1:10. In another embodiment, the ratio between the
surface area of the outer sole to the combined surface area of the bases of the two
bulbous protuberances is 15:1 to 5:1. In another embodiment, the ratio between the
surface area of the outer sole to the combined surface area of the bases of the two
bulbous protuberances is 10:1 to 3:1. In another embodiment, the ratio between the
surface area of the outer sole to the combined surface area of the bases of the two
bulbous protuberances is 8:1 to 1:1. In another embodiment, the ratio between the
surface area of the outer sole to the combined surface area of the bases of the two
bulbous protuberances is 12:1 to 7:1.
[0092] In another embodiment, the ratio between the surface area of the outer sole (the
surface are facing the ground) to the surface area of a base of at least one bulbous
protuberance of the two bulbous protuberances is 40:1 to 18:1. In another embodiment,
the ratio between the surface area of the outer sole to the surface area of a base
of at least one bulbous protuberance of the two bulbous protuberances is at least
10:1. In another embodiment, the ratio between the surface area of the outer sole
to the surface area of a base of at least one bulbous protuberance of the two bulbous
protuberances is at least 20:1.
[0093] In another embodiment, the ratio between the minimal width of the inner sole to the
minimal diameter of the base of at least one bulbous protuberance of the two bulbous
protuberances is 2:1 to 1:1.5. In another embodiment, the ratio between the minimal
width of the inner sole to the minimal diameter of the base of at least one bulbous
protuberance of the two bulbous protuberances is 1:0.8 to 1:1.2. In another embodiment,
the ratio between the minimal width of the inner sole to the minimal diameter of the
base of at least one bulbous protuberance of the two bulbous protuberances is at least
1:0.4. In another embodiment, the ratio between the minimal width of the inner sole
to the minimal diameter of the base of at least one bulbous protuberance of the two
bulbous protuberances is at least 1:0.6. In another embodiment, the ratio between
the minimal width of the inner sole to the minimal diameter of the base of at least
one bulbous protuberance of the two bulbous protuberances is less than 1:1.8. In another
embodiment, the ratio between the minimal width of the inner sole to the minimal diameter
of the base of at least one bulbous protuberance of the two bulbous protuberances
is less than 1:1.5.
[0094] In another embodiment, the ratio between the maximal width of the inner sole to the
minimal diameter of the base of at least one bulbous protuberance of the two bulbous
protuberances is 5:1 to 1:1. In another embodiment, the ratio between the maximal
width of the inner sole to the minimal diameter of the base of at least one bulbous
protuberance of the two bulbous protuberances is 4:1 to 1:1. In another embodiment,
the ratio between the maximal width of the inner sole to the minimal diameter of the
base of at least one bulbous protuberance of the two bulbous protuberances is less
than 8:1. In another embodiment, the ratio between the maximal width of the inner
sole to the minimal diameter of the base of at least one bulbous protuberance of the
two bulbous protuberances is less than 6:1. In another embodiment, the ratio between
the maximal width of the inner sole to the minimal diameter of the base of at least
one bulbous protuberance of the two bulbous protuberances is less than 4:1.
[0095] In another embodiment, the ratio between the maximal width of the inner sole to the
maximal diameter of the base of at least one bulbous protuberance of the two bulbous
protuberances is 2:1 to 1:2. In another embodiment, the ratio between the maximal
width of the inner sole to the maximal diameter of the base of at least one bulbous
protuberance of the two bulbous protuberances is 1:0.8 to 1:1.2. In another embodiment,
the ratio between the maximal width of the inner sole to the maximal diameter of the
base of at least one bulbous protuberance of the two bulbous protuberances is at least
1:0.4. In another embodiment, the ratio between the maximal width of the inner sole
to the maximal diameter of the base of at least one bulbous protuberance of the two
bulbous protuberances is at least 1:0.6. In another embodiment, the ratio between
the maximal width of the inner sole to the maximal diameter of the base of at least
one bulbous protuberance of the two bulbous protuberances is less than 1:1.8. In another
embodiment, the ratio between the maximal width of the inner sole to the maximal diameter
of the base of at least one bulbous protuberance of the two bulbous protuberances
is less than 1:1.5.
[0096] In another embodiment, the ratio between the minimal width of the outer sole to the
minimal diameter of the base of at least one bulbous protuberance of the two bulbous
protuberances is 2:1 to 1:1.5. In another embodiment, the ratio between the minimal
width of the outer sole to the minimal diameter of the base of at least one bulbous
protuberance of the two bulbous protuberances is 1:0.8 to 1:1.2. In another embodiment,
the ratio between the minimal width of the outer sole to the minimal diameter of the
base of at least one bulbous protuberance of the two bulbous protuberances is at least
1:0.4. In another embodiment, the ratio between the minimal width of the outer sole
to the minimal diameter of the base of at least one bulbous protuberance of the two
bulbous protuberances is at least 1:0.6. In another embodiment, the ratio between
the minimal width of the outer sole to the minimal diameter of the base of at least
one bulbous protuberance of the two bulbous protuberances is less than 1:1.8. In another
embodiment, the ratio between the minimal width of the outer sole to the minimal diameter
of the base of at least one bulbous protuberance of the two bulbous protuberances
is less than 1:1.5.
[0097] In another embodiment, an area of a base of a protuberance as described herein maximizes
support to the user's foot. In another embodiment, the combined areas of the bases
of the two protuberances enable the two protuberances, alone, as described herein
to support a user.
[0098] In some embodiments, a protuberance is compressible. In some embodiments, a protuberance
is shock absorbing. In some embodiments, a protuberance is deformable. In some embodiments,
a protuberance is compressible or deformable upon pressure exerted by subject's weight.
Each possibility represents a separate embodiment of the present invention.
[0099] In some embodiments, a protuberance is made of a shock absorbing material. In some
embodiments, a protuberance is made of rubber. In another embodiment, a protuberance
is composed of at least one elastomer. In some embodiments, a protuberance is made
of an elastic material. In some embodiments, a protuberance is made of a continuous
elastic material. In some embodiments, a protuberance is made of a "non-hookean" material.
In some embodiments, the elasticity of a protuberance is stress dependent. In some
embodiments, a protuberance is composed of a material that is sensitive to temperature
and loading rate. In some embodiments, a protuberance is not a spring. In another
embodiment, a protuberance is devoid of a spring. In another embodiment, a protuberance
is devoid of a spring.. In another embodiment, a protuberance does not have high yield
strength and therefore cannot return to its original shape upon significant bending
or twisting. In another embodiment, a protuberance is made of a material that does
not exert force that is disproportional to its change in length.
[0100] In another embodiment, a protuberance has a measure of less than 10 Young's modulus
in GPa. In another embodiment, a protuberance has a measure of less than 7.5 Young's
modulus in GPa. In another embodiment, a protuberance has a measure of less than 5
Young's modulus in GPa. In another embodiment, a protuberance has a measure of 0.01
to 7.5 Young's modulus in GPa. In another embodiment, a protuberance has a measure
of 0.01 to 5 Young's modulus in GPa.
[0101] In another embodiment, a protuberance has a density in g/cm3 of less than 2. In another
embodiment, a protuberance has a density in g/cm3 of less than 1.8. In another embodiment,
a protuberance has a density in g/cm3 of 0.5 to 2. In another embodiment, a protuberance
has a density in g/cm3 of 0.7 to 1.8. In another embodiment, a protuberance has a
density in g/cm3 of 0.7 to 1.5. In another embodiment, a protuberance has an elastic
limit of 200% (stretched 200% and returned to original shape). In another embodiment,
a protuberance has an elastic limit of 180%. In another embodiment, a protuberance
has an elastic limit of 150%. In another embodiment, a protuberance has an elastic
limit of 125%.
[0102] In some embodiments, a protuberance has a convexity defined as follows (see Fig.
19): A cross section of the curvature of the protuberance, from a circumference thereof
to an apex thereof, may be delimited between graphs of the following two functions:
[0103] Reference is now made to Fig. 19, which shows a first graph 1000 illustrating function
(1) and a second graph 1002 illustrating function (2). The circumference of the protuberance
is at x, y = 0 for both functions. The apex of the protuberance is at x = m for both
functions, whereas the y-axis value of the apex may be between n1 for function (1)
and n2 for function (2). The apex of the protuberance is its highest point relative
to its circumference. The apex may be at a horizontal center of the curvature, or
be offset from that horizontal center. As an alternative to a single point, the apex
may span over a flat, horizontal area.
[0104] In another embodiment, the cross section of the curvature of the protuberance may
be continuous or comprised of discrete segments. In another embodiment, the protuberance
may be separated (fully or partially) into numerous bodies, which are spaced apart
horizontally, but whose end surfaces form the aforesaid curvature. Namely, if those
end surfaces are interpolated to form a continuous line, the portion of that line
which spans between the circumference of the protuberance to the apex thereof would
be delimited between functions (1) and (2).
[0105] In another embodiment, at least one protuberance has an abrasion resistance of between
1 to 125 mm
3 (by DIN 53516). In another embodiment, at least one protuberance has an abrasion
resistance of between 1 to 20 mm
3. In another embodiment, at least one protuberance has an abrasion resistance of between
1 to 60 mm
3. In another embodiment, at least one protuberance has an abrasion resistance of between
20 to 110 mm
3. In another embodiment, at least one protuberance has an abrasion resistance of between
40 to 80 mm
3. In another embodiment, at least one protuberance has an abrasion resistance of between
30 to 60 mm
3. In another embodiment, at least one protuberance has an abrasion resistance of between
50 to 120 mm
3.
[0106] In another embodiment, at least one protuberance has an abrasion resistance of less
than 125 mm
3 (by DIN 53516). In another embodiment, at least one protuberance has an abrasion
resistance of less than 100 mm
3. In another embodiment, at least one protuberance has an abrasion resistance of less
than 80 mm
3.
[0107] In another embodiment, a protuberance comprises a rubber cup. In another embodiment,
a protuberance comprises natural rubber compounds. In another embodiment, a protuberance
comprises synthetic rubber compounds such as TPU or TPR. In another embodiment, a
protuberance comprises silicone. In another embodiment, a protuberance a plastic material
such as PA 6 (nylon), PA6/6 (nylon) + glass fiber, ABS, TPU, Glass fiber, Polypropylene,
POM (Polyoxymethylene), or any combination thereof. In another embodiment, a protuberance
comprises a metal such as aluminum, steel, stainless steel, brass, or metal alloys.
In another embodiment, a protuberance comprises compound materials such as glass fibers,
carbon fibers, kevlar, or any combination thereof. Each possibility represents a separate
embodiment of the present invention.
[0108] In another embodiment, the basic requirement for continuous balancing a user with
footwear of the invention is achieved when the device comprises two protuberances
having a base surface as described, in a column-like order and in the offset arrangement.
In another embodiment, the bulbous structure of the protuberance together with its
shore hardness, limited deformation capacity, and its shock absorbing capacity are
of great importance for continuous balancing a user. In another embodiment, the protuberance's
hardness allows limited deformity/ compressibility.
[0109] In another embodiment, limited deformity/compressibility results in less than 20%
protuberance height loss upon maximal impact (the entire weight of the subject is
exerted on the protuberance). In another embodiment, limited deformity/compressibility
results in less than 15% protuberance height loss upon maximal impact. In another
embodiment, limited deformity/compressibility results in less than 10% protuberance
height loss upon maximal impact. In another embodiment, limited deformity/compressibility
results in less than 20% protuberance diameter (any diameter along the protuberance)
increase upon maximal impact. In another embodiment, limited deformity/compressibility
results in less than 15% protuberance diameter increase upon maximal impact. In another
embodiment, limited deformity/compressibility results in less than 12% protuberance
diameter increase upon maximal impact.
[0110] In another embodiment, the basic requirement for continuous balancing a user with
footwear of the invention is achieved when the device-footwear comprises two bulbous
protuberances having a base surface as described, in a column-like order, in the offset
arrangement, having a shore hardness as defined herein, having limited deformation
capacity, and having shock (energy) absorbing capacity (as opposed to a spring). In
another embodiment, offset arrangement refers to the peak of the protuberances as
being offset). In another embodiment, does not include the base the protuberance's
is not in an offset arrangement/position.
[0111] In another embodiment, the phrase "continuous balancing a user" includes constantly
inducing a user to stabilize his posture and gait with minimal risk of falls and injuries.
In another embodiment, the phrase "continuous balancing a user" includes developing
proprioceptive and/or kinesthetic skills in a user. In another embodiment only the
two bulbous protuberances can support the user's foot when the two spring elements
are placed on a ground surface.
[0112] In another embodiment, a shoe of the footwear is in a balanced position, wherein
the balanced position is a position whereby the device provides a reduced inversion
or a reduced eversion to the subject's foot during the stance phases. In another embodiment,
a balanced position is a position wherein at least one protuberance is offset with
respect to the centerline. In another embodiment, a balanced position is a position
wherein the forward protuberance, the rearward protuberance, or both are offset with
respect to the centerline. In another embodiment, when both the forward protuberance
and the rearward protuberance are offset with respect to the centerline, each protuberance
is within or on a different side of the centerline (dividing the outer-sole/innersole
to 2). In another embodiment, when both the forward protuberance and the rearward
protuberance are offset with respect to the centerline, each protuberance peak is
within or on a different side of the centerline.
[0113] In another embodiment, each position described hereinbelow is characterized by at
least one protuberance being offset with respect to a centerline. In another embodiment,
each calibration refers to the balanced position as the initial position. In another
embodiment, after each calibration the forward protuberance, the rearward protuberance,
or both are offset with respect to the centerline.
[0114] In another embodiment, an activity of a dorsi-flexor is increased by positioning
the posterior protuberance to 2 mm-25 mm posteriorly from the balanced position. In
another embodiment, an activity of a dorsi-flexor is increased by positioning the
posterior protuberance to 5 mm-15 mm posteriorly from the balanced position. In another
embodiment, an activity of a dorsi-flexor is increased by heightening the posterior
protuberance. In another embodiment, an activity of a dorsi-flexor is increased by
heightening the posterior protuberance by 0.5 mm-15 mm. In another embodiment, heightening
the posterior protuberance results in a posterior protuberance which is 0.5 mm-15
mm higher than the anterior protuberance. In another embodiment, an activity of a
plantar flexor is increased by positioning the posterior protuberance to 2 mm-25 mm
anteriorly from the balanced position. In another embodiment, an activity of a plantar-flexor
is increased by heightening (raising) the anterior protuberance. In another embodiment,
an activity of an ankle evertor is increased by positioning the posterior protuberance
to 0.5 mm-15 mm medially from the balanced position. In another embodiment, an activity
of an ankle evertor is decreased by positioning the posterior protuberance to 0.5
mm-25 mm laterally from the balanced position. In another embodiment, an activity
of an ankle dorsiflexor is decreased by heightening (adding at least one spacer) the
anterior protuberance from the neutral position which is the balanced position (the
position wherein the device provides a reduced inversion or a reduced eversion to
the subject's foot).
[0115] In another embodiment, an activity of the pes anserinus muscles (sartorius semitendinosus
and gracilis) is decreased by positioning the posterior protuberance laterally from
the neutral position which is the balanced position. In another embodiment, an activity
of the quadriceps muscle is increased by positioning the posterior protuberance posteriorly
from the neutral position which is the balanced position. In another embodiment, an
activity of the hamstring muscle is increased by positioning the posterior protuberance
anteriorly from the neutral position which is the balanced position. In another embodiment,
an activity of the lateral knee muscles (vastus lateralis) is increased by positioning
the posterior protuberance posteriorly and medially from the neutral position which
is the balanced position. In another embodiment, an activity of the knee flexor muscles
(gastrocnemius and hamstrings) is increased by heightening the anterior protuberance.
In another embodiment, an activity of a hip external rotator muscle is increased by
positioning the posterior protuberance to 2-20 mm medially from the balanced position.
In another embodiment, an activity of a hip extensor muscle is increased by expanding
the height of the anterior protuberance from the neutral position which is the balanced
position
[0116] In another embodiment, a balanced position is the position in which the footwear
exerts the least valgus, varus, dorsal or plantar torque about the ankle in a subject.
In another embodiment, a balanced position is the position in which the footwear provides
the least or minimal lower limbs muscle activity. In another embodiment, a balanced
position is the position in which the footwear provides balanced lower limbs muscle
activity. In another embodiment, a balanced position is toning lower limb muscles.
In another embodiment, a balanced position is toning the amount of tension or resistance
to movement in a muscle involved in gait. In another embodiment, a balanced position
is lower limb unloading that allows maximal ankle, knee, and hip joint mobility. In
another embodiment, a balanced position is providing a reduction of muscle activity,
larger passive ankle excursion, improved gait ability, or any combination thereof.
In another embodiment, a balanced position is increasing step length, stance symmetry,
or a combination thereof. In another embodiment, a balanced position is increasing
the length of the force point of action in lower limb muscles such as but not limited
to: soleus, tibialis posterior, and both gastrocnemius muscles.
[0117] In another embodiment, bi-lateral knee osteoarthritis is treated by using protuberances
with soft hardness or resilience. In another embodiment, correction of early heel-rise
in both right and left leg includes: (1) a 2mm hard spacer is placed between the left
posterior BP and the left shoe in order to bring the left foot to a slight plantar-flexion;
and (2) a 2mm hard spacer is placed between the right posterior BP and the right device
in order to bring the right foot to a slight plantar-flexion.
[0118] In another embodiment, bi-lateral patello-femoral pain syndrome with a slight lateralization
of the patellae in the left and right knees is treated by using protuberances having
"hard" hardness or resilience, a 100 g spacer (disc shape) of 3mm was introduced between
the outsole and the posterior BP under the left leg and the right leg and (in order
to maintain the anterior BPs at the same height and not create a plantar flexion)
and a hard spacer and a soft spacer were introduced between the anterior BP and shoe
both under the left leg and the right leg.
[0119] As seen in FIG. 2, the posterior protuberance is positioned generally underneath
a calcaneus (heel, ankle) support portion 23 of support member 12. In some embodiments,
the anterior protuberance may be positioned generally underneath a metatarsals support
portion 25 and/or phalanges support portion 27 of support member 12.
[0120] FIG. 12 is a simplified pictorial illustration of an alignment of the anterior (forward)
and posterior (rearward) protuberances on a support member 200, according to embodiments
of the present invention.
[0121] Centerline 216, in the embodiment shown in FIG. 12 is defined as a longitudinal straight
line (median) that connects the middles of short sides 214 of a rectangle 212, the
long sides 212 of which are parallel to centerline 216, and which delimits the contour
210 of the support member. In embodiments of the present invention contour 210 is
the contour (254, see FIG. 14) of the foothold confined by the upper part (252, see
FIG. 14) of the footwear (250, see FIG. 14), corresponding to the last which is used
to form the footwear. In other embodiments of the present invention contour 210 is
the outermost contour of the footwear. In other embodiments of the present invention
contour 210 is the contour of the bottom surface of the sole of the footwear.
[0122] According to embodiments of the present invention, as shown in FIG. 12, forward protuberance
218 at the anterior (phalanges) portion of the support member (i.e. its front portion)
is positioned medially offset to centerline 216. By "medially offset" is meant that
a peak surface of protuberance 218 (marked by cross 219) is shifted from centerline
216 medially towards the inner side of support surface 200, facing the support member
of the other foot (not shown in this figure). The peak surface is a surface on the
protuberance which is furthest from the support surface with respect to other surfaces
of the protuberance, and which comes in contact with the ground, when the user attaches
the support member to the foot, and walks or stands on the ground.
[0123] According to embodiments of the present invention, as shown in FIG. 12, rearward
protuberance 220 at the posterior (calcaneus) portion of the support member (i.e.
its back portion) is positioned laterally offset to centerline 216. By "laterally
offset" is meant that a peak surface of protuberance 220 (marked by cross 221) is
shifted from centerline 216 laterally towards the outer side of support surface 200,
away from the support member of the other foot (not shown in this figure).
[0124] In some embodiments of the present invention only forward protuberance 218 is offset
medially, while rearward protuberance 220 is substantially aligned with centerline
216. In some embodiments of the present invention only rearward protuberance 220 is
offset medially, while forward protuberance 218 is substantially aligned with centerline
216.
[0125] The alignment of the protuberances shown in FIG. 12 is useful, for example, for exercising
users with one or more of the following medical indications: medial compartment-knee
osteoarthritis (OA), medical meniscus tear or damage, genu varus, patello-femoral
pain syd, patello-femoral problem (malalignment), lateral collateral ligamental damage
or tear, bone bruise or avascular necrosis of the medial tibial plateau or the medial
femoral condyle MTP/MFC (AVN), low back pain, hip OA, hip labrum damage (TCM), trochanteric
bursitis, pes anseninus bursitis, ankle instability (supination and ext rut), achilles
tendonitis and metatarsalgia.
[0126] FIG. 13 is a simplified pictorial illustration of another alignment of the anterior
and posterior protuberances on a support member, according to embodiments of the present
invention.
[0127] According to embodiments of the present invention, as shown in FIG. 13, forward protuberance
218 is laterally offset to centerline 216, whereas rearward protuberance 220 is medially
offset to centerline 216.
[0128] In some embodiments of the present invention only forward protuberance 218 is offset
laterally, while the rearward protuberance 220 is substantially aligned with centerline
216. In some embodiments of the present invention only rearward (posterior) protuberance
220 is offset laterally, while the forward (anterior) protuberance 216 is substantially
aligned with centerline 216.
[0129] The alignment of the protuberances shown in FIG. 12 is useful, for example, for exercising
users with one or more of the following medical indications: lateral meniscus tear
or damage, lateral compartment knee osteoarthritis, valgus knee (genu valgus), patello-femoral
pain syndrome, patello-femoral problem (malalignment),Medial collateral Ligament tear,
bone bruise or avascular necrosis of the lateral tibial plateau or lateral femoral
condyle hip labrum damage or tear, hip pain, ankle instability (pronoation), achilles
tendonitis, tibilias insufficiency and metatarsalgia.
[0130] FIG. 14 is a simplified pictorial illustration of a sneaker 250 constructed and operative
in accordance with an embodiment of the present invention, whose rearward protuberance
220 has a greater height than the height of the forward protuberance 218. It is noticeable
that such arrangement facilitates initial contact between rearward protuberance 220
and the supporting ground (not shown in this figure) when a user wears the sneaker,
before the forward protuberance is brought in contact with the ground. When both protuberances
are placed in contact with the ground the foot of the user wearing sneaker 250 acquires
a downward inclination with respect to direction of gait of the user.
[0131] FIG. 15 is a simplified pictorial illustration of a sneaker 250 constructed and operative
in accordance with an embodiment of the present invention, whose forward protuberance
218 has a greater height than the height of the rearward protuberance 220. In this
embodiment when both protuberances are placed in contact with the ground the foot
of the user wearing sneaker 250 acquires an upward inclination (with respect to the
direction of gait of the user.
[0132] FIG. 16 illustrates maximal area boundaries of positioning of the anterior and posterior
protuberances with respect to a support surface, according to embodiments of the present
invention. Shown in this figure is a bottom view of a sneaker designed to be worn
on a right foot of a user. The medial side is thus the right side of the drawing,
facing the arc of greater curvature of the side arcs of the sneaker. The lateral side
is opposite to the medial side that is the left side of the drawing, facing the arc
of lesser curvature of the side arcs of the sneaker. A grid is provided, dividing
rectangle 202 to 6*6 sub-rectangles (other divisions may apply too), to aid in the
determining the position of the protuberances.
[0133] Indicated are the midsole 401 and contour 402 of the foothold which is determined
by the last used in the making of the sneaker, 403 marking the medial curvature of
contour 402. Front rail 404 and rear rail 405 are used for anchoring the protuberance.
The area bordered by dotted line 406 marks the maximal area within which the peak
surface of the anterior protuberance, i.e. the ground engaging surface of the anterior
protuberance, may be located, according to some embodiments of the present invention.
On the 6*6 grid, area 406 mainly stretches across the second row of sub-rectangles
(counting from the front), and some of the third row of sub-rectangles. The area bordered
by dotted line 407 marks the maximal area within which the peak surface of the posterior
protuberance. On the 6*6 grid, area 407 mainly stretches across the third and forth
sub-rectangles (adjacent centerline 216) of the fifth row (counting form the front)
of the grid.
[0134] FIG. 17 illustrates the effective area boundaries of positioning of the anterior
and posterior protuberances with respect to a support surface, according to embodiments
of the present invention. Indicated are the midsole 501 and outsole 502, contour 503
of the foothold which is determined by the last used in the making of the sneaker.
[0135] The area bordered by dotted line 504 marks the effective area within which the peak
surface of the anterior protuberance, i.e. the ground engaging surface of the anterior
protuberance, may be located, according to some embodiments of the present invention.
On the 6*6 grid, area 504 mainly stretches across four sub-rectangles-two on either
sides of centerline 216, of the second row of sub-rectangles (counting from the front),
and some of the third row of sub-rectangles.
[0136] The area bordered by dotted line 505 marks the effective area within which the peak
surface of the posterior protuberance. "Effective" refers to the effectiveness of
use of the footwear according to embodiments of the present invention, which facilitates
noticeable and useful proprioceptive/kinesthetic workout. On the 6*6 grid, area 505
mainly stretches across the third and forth sub-rectangles (adjacent centerline 216)
of the fifth row (counting form the front) of the grid.
[0137] It is noted that the term "bulbous protuberance" is taken in the broadest sense to
also include a cut bulbous protuberance, a truncated bulbous protuberance, a trimmed
bulbous protuberance. If trimmed or cut, the trimmed or cut portion serves as the
ground engaging of the protuberance, the base surface or both (e.g. both sides are
cut or trimmed).
[0138] FIG. 18A is an isometric view of a protuberance suitable for use on a footwear, according
to embodiments of the present invention. Cleats 901 are provided on the surface of
the protuberance for facilitating enhanced grip of the surface on which the user stands
or walks. In some embodiments, spikes or grip means are constructed of any suitable
material, such as but not limited to: elastomers such as rubbers or plastic materials.
In some embodiments, spikes or grip means cover only a portion of a protuberance.
In some embodiments, spikes or grip means cover at least a ground engaging surface
of a protuberance (the surface in contact with the ground during stance). In some
embodiments, a fixing means for securing a protuberance to the support portion is
embedded within a spikes or a grip means. In some embodiments, a fixing means for
securing a protuberance to the support portion is places in between spikes or a grip
means. Each possibility represents a separate embodiment of the present invention.
[0139] FIG. 18B is a frontal view of a protuberance suitable for use on a footwear, according
to embodiments of the present invention. The peak surface is marked by cross 902.
Bore 904 is provided for a screw or other fastening arrangement to fix the protuberance
in the desired position.
[0140] FIG. 18C is a side view of a protuberance suitable for use on a footwear, according
to embodiments of the present invention. Convexity 905 of the protuberance is clearly
seen. Various convexities may be employed, all of which define a peak surface, typically
(but not necessarily) at the center of the protuberance, which is the surface which
comes in contact with the ground, when the user attaches the support member to the
foot, and walks or stands on the ground.
[0141] It will be appreciated by persons skilled in the art that the present invention is
not limited by what has been particularly shown and described hereinabove. Rather
the scope of the present invention includes both combinations and subcombinations
of the features described hereinabove as well as modifications and variations thereof
which would occur to a person of skill in the art upon reading the foregoing description
and which are not in the prior art.
EXAMPLES
EXAMPLE 1: Treating a Bi-lateral knee osteoarthritis (medial compartment, genu varus)
with a device of the invention
[0142] A 68 years old patient presented to the clinic with a major complaint of bi-lateral
knee OA.
[0143] Anamnesis: Patient complained on bi-lateral knee pain, primarily in the left knee
that lasted for 5 years prior to the visit. Patient experienced gradual pain increase
and decrease in function (walking, ascending and descending stairs). Pain degree while
walking was 6/10 (on a visual analogue scale of 10cm, higher value means more severe).
Patient suffered from moderate stiffness in the morning hours and a severe difficulties
in getting out of cars.
[0144] Physical examination: Thigh muscles were atrophied. Knees were in varus alignment
with limited knee extension on both sides (Lt.: -10° , Rt.: -5°). Palpation was characterized
by tenderness on the medial joint line on the left and knee and in the pes anserinus
region in the left knee. The right knee was also characterized by tenderness likewise
the medial joint line and pes anserinus region were also characterized by tenderness.
During walking patient experienced pain in the medial joint line in both knees in
the heel-strike phase (VAS 5/10 in the left knee and 3/10 in the right knee). Patient
also experienced pain in the pes anserinus region in the mid-stance to toe-off phase.
[0145] Imaging and lab: Knee X-ray in standing position: Antero-Posterior view reveals a
joint space narrowing on the medial compartment and osteophytes, Kellgren & Lawrence
classification 3 in both knees. Gait lab results (see table 1) showed velocity of
93 cm/sec, single limb support of 37.0% in the left leg and 38.1% in the right knee
Step length: Left.: 61 cm Right .60 cm.
Table 1: Patient's gait parameters
Visit |
Velocity (cm/sec) |
Left step length (cm) |
Right Step length (cm) |
Left Single Limb Support (in % of step cycle) |
Right Single Limb Support (in % of step cycle) |
1st (initial) |
93 |
61 |
60 |
37.0 |
38.1 |
2nd (first follow-up) |
99 |
64 |
63.2 |
37.4 |
38.3 |
3rd (second follow-up) |
106 |
65 |
64.2 |
37.7 |
38.5 |
4th (third follow-up) |
110 |
65.5 |
65.0 |
38.0 |
38.6 |
Treatment
[0146] Bulbous protuberances (BPs with the lowest convexity (A) and soft hardness or resilience
were placed under the hind foot and fore-foot.
[0147] Balancing: Patient was balanced by visually by reducing eversion and inversion through
heel-strike, mid-stance and toe-off.
[0148] Pain: In order to reduce pain in the right medial knee joint line in heel-strike
posterior right BP was shifted 1-2mm laterally and fixed. Patient was then asked to
walk 20 m with the device and reported reduction of pain from 5/10 to 3/10. Posterior
right element was shifted 1-2mm further laterally. Patient reported that pain disappeared
in the right medial joint line while walking with the device.
[0149] In order to reduce the pain in the right pes anserinus, the anterior right BP was
shifted 1-2 mm medially. At this point the patient reported he had no more pain in
the right pes anserinus region while walking with the device.
[0150] In order to reduce pain in the left medial knee joint line in heel-strike the left
posterior BP was shifted 1-2mm laterally. Patient than reported a reduction of walking
pain from 5/10 to 3/10 when wearing the device. After the left posterior BP was shifted
1-2mm laterally the patient reported further reduction of pain to 2/10 in the left
medial knee joint line while walking with the device. A further lateral shift of the
left posterior BP increased the eversion in heel-strike in the left leg so patient
was out of balance. Therefore, the left posterior BP was shifted back to the last
position (where pain was 2/10 while walking).
[0151] In order to reduce the pain in the left pes anserinus, the anterior left BP was shifted
1-2 mm medially. At this point the patient reported a reduction of pain in the left
pes anserinus region while walking with the device. After the left anterior BP was
shifted additional 1-2 mm medially, pain disappeared in the left pest anserinus region
upon walking with the device.
[0152] Heel-rise timing: Patient was asked to walk 20 m in order to confirm that he was
still balanced and the heel-rise timing is proper. It was noted that the patient had
early heel-rise in both right and left leg. At this phase a 2mm hard spacer was placed
between the left posterior BP and the left shoe in order to bring the left foot to
a slight plantar-flexion. This time heel rise timing was proper in the left leg. At
this phase a 2mm hard spacer was placed between the right posterior BP and the right
device in order to bring the right foot to a slight plantar-flexion. This time heel
rise timing was proper in the right leg as well as in the left leg.
[0153] Prescription: On week 1 Patient was briefed with safety instructions and was asked
to wear the device at home for 45 minutes daily (and walk in accumulative about 5
minutes a day as part of his daily activities at home). Patient was instructed to
increase daily wearing time of the device by 5 minutes every week for the initial
6 weeks, reaching 75 minutes wearing time with the device every day (12-15 minutes
of accumulative walking). Patient was monitored in the treatment center 6 weeks after
his first visit, 3 months after his first visit, and 6 months after his first visit.
[0154] Treatment: Patient immediately reported reduction in pain while walking with the
device; patient gradually reported a decrease in pain also when walking without the
device device. In the follow-up visits gait velocity was increased to 110 cm/sec an
increase in step length of 65.5 cm in the left leg and 65.0 cm in the right leg, was
observed. Single limb support bi-laterally was increased to 38.0 % in the left leg
and 38.6% in the right leg, patient had a lower difference between the single limb
support of the right and the left leg (a more symmetric gait). After 10 weeks of treatment
the patient reported that pain was substantially reduced during walking without the
device and he found it much easier to stand for long periods. Patient gradually increased
the daily use of the device, until reaching a daily usage of up to 3 hours a day.
After 3 months patient was also allowed to walk outdoors with the device. After the
initial 6 months patient continued follow-up visits twice-three times a year.
EXAMPLE 2: Treating a Patello-femoral pain syndrome (Hyper-laxity and genu valgus)
with a device of the invention
[0155] A 30 years old female patient presented to the clinic with a diagnosis of patello-femoral
pain syndrome.
[0156] Anamnesis: Patient complained of suffering from bi-lateral knee pain for the last
5 years. Left knee was more painful than the right knee. During the last 6 months
there was an exacerbation in pain level to a level of approx. 5/10 on a visual analogue
scale (exacerbation appeared following an intensive day of cleaning the house). She
reported that she experiences anterior knee pain during sitting with flexed knees
for over 20 minutes (moviegoers' knee). The patient who was an amateur dancer and
ceased dancing since pain intensified. Patient reported of being extra flexible since
childhood.
[0157] Physical examination: Patient had valgus alignment and recurvatum in both knees.
On palpation tenderness was noted on the medial side of the patella. Patellar compression
test was positive. When examining the patient's gait, patient reported pain is in
the medial side of the patella while walking, pain appeared in heel-strike and is
higher in the left knee compared to the right knee, 5/10 and 3/10, respectively.
[0158] Imaging/Gait: X-ray of the knees showed a slight lateralization of the patellae in
the left and right knees. Gait lab results showed a velocity of 110 cm/sec, single
limb support of 41.8% in the right leg and 42.4 % in the left knee. Step length: Left:
57 cm Right .58 cm.
[0159] Treatment: identical BPs with B convexity and "hard" hardness or resilience were
placed under the hind foot and fore-foot in the left and in the right leg. A 100 g
spacer (disc shape) of 3mm was introduced between the outsole and the posterior BP
under the left leg and the right leg and (in order to maintain the anterior BPs at
the same height and not create a plantar flexion) a hard spacer and a soft spacer
were introduced between the anterior BP and shoe both under the left leg and the right
leg.
[0160] Balancing: Patient was balanced by visually, reducing eversion and inversion through
heel-strike, mid-stance and toe-off.
[0161] Pain: In order to reduce pain in the right patella in heel-strike posterior BP was
shifted 3 mm anteriorly and 2 mm medially under the right leg. Patient then reported
feeling no pain in the right knee while walking with the device. In order to reduce
pain in the left patella in heel-strike posterior BP was shifted 3 mm anteriorly and
2 mm medially under the left leg. Patient then reported feeling a 70% decrease in
pain at the medial side of the patella in the left knee while walking with the device.
At this point posterior BP of the left foot was shifted further 1mm anteriorly. Patient
reported that walking with the current configuration of the device left her only with
very mild pain (1-2/10) in the medial side of the left patella.
[0162] Heel-rise timing: Patient was asked to walk 20 m in order to confirm that she is
still balanced and the heel-rise timing is proper. It was noted that the patient had
delayed heel-rise in both right and left foot. At this phase a 2mm hard spacer was
placed between the left anterior BP and the left shoe in order to bring the left foot
to a slight dorsi-flexion. Patient was observed walking with the device - heel rise
timing was proper in the left foot. At this phase a 2mm hard spacer was placed between
the right anterior BP and the right shoe in order to bring the right foot to a slight
dorsi-flexion. Patient was observed walking with the device - heel rise timing was
now proper in the right leg.
[0163] Prescription: Patient was briefed with safety instructions and was asked on week
1 to wear the device at home for 45 minutes daily (and walk in accumulative about
5 minutes a day as part of his daily activities at home). Patient was instructed to
increase daily walking time with the device by 5 minutes every week for the initial
4 weeks, reaching 60 minutes wearing time of the device every day (accumulatively
walking or standing 7-10 minutes a day). Patient was monitored in the treatment center
4 weeks after her first visit, 10 weeks after her first visit, and 5 months after
her first visit.
[0164] Treatment course: Patient immediately reported reduction in pain while walking with
the device; patient gradually reported a decrease in pain also when walking without
the device to a level of 2/10 after 3 months. She was now able to sit for long periods
of time without pain and walked painlessly without the device. In the follow-up visits
an increase in step length bi-laterally, a decrease in step length difference, a decrease
in single limb support bi-laterally (towards 40%) and a decrease in single limb support
difference (see table 2 for gait parameters) were observed. Patient gradually increased
the daily use of the device, until reaching a daily usage of 2 hours after 5 months
(accumulative walking of 20 minutes a day). After 5 months patient arrived to 2-3
follow-ups every year.
Table 2: Patient's gait parameters
Visit |
Velocity (cm/sec) |
Left step length (cm) |
Right Step length (cm) |
Left Single Limb Support (in % of step cycle) |
Right Single Limb Support (in % of step cycle) |
1st (initial) |
110 |
58 |
57 |
42.4 |
41.8 |
2nd (first follow-up) |
117 |
61 |
60.2 |
42.0 |
41.5 |
3rd (second follow-up) |
120 |
63 |
62.3 |
41.6 |
41.1 |
4th (third follow-up) |
125 |
64 |
63.5 |
41.1 |
40.7 |
EXAMPLE 3: Treating a degenerative medial meniscus tear (Radial tear in the posterior
horn of the medial meniscus) with a device of the invention
[0165] 57 years old patient presented to the clinic with a major complaint of left medial
meniscus tear.
[0166] Anamnesis: Patient suffered from occasional knee pain for the last 6 years with symptoms
alternating between left and right knees. 4 weeks prior to arrival to the clinic he
had an event of acute pain in his left knee while having is evening walk. He ruled
out any knee trauma.
[0167] Upon admission pain in the left knee is 6/10 (on a visual analogue scale of 10cm)
in the medial joint line. Patient reports that he suffered great pain upon walking
and unable to fully extend his knee.
[0168] Physical examination: In inspection the knees are in varus alignment. The left knee
is slightly flexed when standing and a mild atrophy of the VMO muscle is apparent.
Patient had limited left knee extension of: 10°. In palpation there was tenderness
on the medial joint line of the left knee and McMurray's Test for the left medial
meniscus was positive. Patient did not extend his left leg fully when walking. Patient
reported of pain in the medial joint line in the left knee in the heel-strike phase.
[0169] Imaging and lab: Knee X-ray while standing: Antero-Posterior view showed mild changes
in the medial compartment bi-laterally. In MRI a radial tear of the posterior horn
of the left medial meniscus was observed. Gait lab results (see table 3) showed velocity
of 85 cm/sec, single limb support of 35.6% in the left leg and 39.5 % in the right
leg Step length: Left.: 60 cm Right .58 cm.
Table 3: Patient's gait parameters
Visit |
Velocity (cm/sec) |
Left step length (cm) |
Right Step length (cm) |
Left Single Limb Support (in % of step cycle) |
Right Single Limb Support (in % of step cycle) |
1st (initial) |
85 |
60 |
58 |
35.6 |
39.5 |
2nd (first follow-up) |
95 |
63 |
61.3 |
36.9 |
39.3 |
3rd (second follow-up) |
107 |
66 |
64.5 |
37.5 |
39.3 |
4th (third follow-up) |
120 |
68 |
67 |
38.5 |
39.5 |
[0170] Therapy: identical BP's with the B convexity were fixed under the hind-foot and fore-foot
of the patient's right foot. BPs had "soft" hardness. Under the left foot two BPs
with C convexity (which is higher than B) were placed under the hind-foot and fore-foot.
BP's under the left foot had higher convexity in order to introduce higher perturbation/instability
under the left foot, thus, allegedly, promoting more coordinated recruitment of muscles
and reducing the muscle guarding of the left knee. The higher convexity under the
left foot also provided additional height compared to the right foot, thus promoting
"off loading" (a shift of weight of the body from the affected, left leg to the right
leg).
[0171] Balancing: Patient was balanced by visually reducing eversion and inversion through
heel-strike, mid-stance and toe-off.
[0172] Pain: In order to reduce pain in the left medial knee joint line in heel-strike posterior
left BP was shifted 1-2mm laterally. Patient reported pain in the left medial joint
line was reduced while walking with the device from 6/10 to 4/10. At this point left
posterior BP was shifted 1-2mm further laterally. Patient reported that the pain was
further reduced to 2/10. Left posterior BP was shifted 1-2mm further laterally. After
the last lateral shift it was noted that upon heel strike the patient went into increased
eversion and therefore, the left posterior BP was fixed back in the previous position
(Where pain was 2/10).
[0173] Heel-rise timing: Patient was asked to walk 20 m in order to confirm that he is still
balanced and the heel-rise timing is proper. An early heel-rise in the left leg was
observed. A soft spacer of 2mm was introduced between the posterior left BP and the
device. Once the patient walked with the device, heel rise timing was corrected for
the left leg. In this case, the spacer was a soft spacer in order to reduce the impact
in heel strike.
[0174] Prescription: Patient was briefed with safety instructions and was asked to wear
the device at home for 45 minutes a day on week 1 (and walk in accumulative about
5 minutes a day as part of his daily activities at home). Patient was instructed to
increase daily wearing time of the device by 5 minutes every week for the initial
3 weeks, reaching 60 minutes wearing time with the device every day (8-10 minutes
of accumulative walking or standing). Patient was monitored in the treatment center
3 weeks after his first visit, 6 weeks after his first visit, and 3 months after his
first visit.
[0175] Treatment: Patient immediately reported reduction in pain while walking with the
device; patient gradually reported a decrease in pain also when walking without the
device. After 3 months of treatment pain in the left knee was decreased to 2/10. Gait
(see table 3) velocity was increased, an increase in step length of the left and right
leg was observed and single limb support was increased in the left leg and in the
right leg. Patient had a lower difference between the single limb support of the right
and the left leg (a more symmetric gait). The patient reported an increasing alleviation
of pain whilst walking with street shoes or barefooted. Clinical visual gait assessment
showed full extension of the left knee during the stance phase Once pain was reduced,
full extension reached and the symmetry in single limb support improved the different
calibrations on the right and left systems was evened out. The patient had "C" BP's
under the hind-foot and the fore-foot of both legs. The additional soft spacer was
removed from under the posterior left BP
[0176] Patient gradually increased the daily use of the device, until reaching a daily usage
of up to 2 hours a day. After 3 months patient was also allowed to walk outdoors with
the device. After the first 6 months, patient arrived to the center 2-3 times a year
for follow-up visits. The additional spacer that was introduced between the posterior
left BP and the shoe was removed after the difference in single limb support was reduced
below 2%.
EXAMPLE 3: Left Anterior Cruciate Ligament tear (no pain) with a device of the invention
[0177] A 27 years old patient presented to the clinic with a major complaint of left Anterior
Cruciate Ligament (ACL) tear.
[0178] Anamnesis: 2 months prior coming to the clinic the patient twisted his left knee
in a soccer game. Following this event the knee got swollen and painful. Patient was
treated in a physiotherapy clinic since the injury and suffered no pain but had experienced,
twice a week, events of "giving-way" in the left knee. He was also unable to enjoy
in activities such as soccer, running or jumping.
[0179] Physical examination: On observation the knees were in a varus alignment. Anterior
drawer test was positive in the left knee. McMurry and valgus stress tests were negative.
Imaging and lab: MRI revealed that a left ACL tear is present. Gait lab results (see
table 4) showed velocity of 110 cm/sec, single limb support of 38.2% in the left leg
and 40.5 % in the right leg Step length: Left.: 63 cm Right: 62 cm.
Table 4: Patient's gait parameters
Visit |
Velocity (cm/sec) |
Left step length (cm) |
Right Step length (cm) |
Left Single Limb Support (in % of step cycle) |
Right Single Limb Support (in % of step cycle) |
1st (initial) |
110 |
63 |
62 |
38.2 |
40.5 |
2nd (first follow-up) |
123 |
66 |
65.2 |
39.0 |
40.3 |
3rd (second follow-up) |
135 |
70 |
69.5 |
39.5 |
40.1 |
4th (third follow-up) |
140 |
72 |
71.6 |
39.9 |
40 |
[0180] Therapy: identical BPs with B convexity and "hard" hardness were fixed under the
hind-foot and fore-foot of the patient's right foot and the patient's left foot. A
100 g weighted spacer (disc) of 2mm was introduced between the footwear and the posterior
BP under the left foot and the right foot and (in order to maintain the anterior BPs
at the same height and to avoid a plantar flexion) a hard and a soft spacers was introduced
between the anterior BP and outsole both under the left foot and the right foot. The
weighted spacer was introduced in order to induce increased activity in the muscles
of the left leg and right leg. BPs convexity was planned to be increased as the treatment
progressed.
[0181] Balancing: Patient was balanced by visually reducing eversion and inversion through
heel-strike, mid-stance and toe-off.
[0182] Pain: Patient had no pain and was calibrated according to the balancing criteria.
[0183] Heel-rise timing: Patient was asked to walk 20 m in order to confirm that he is still
balanced and the heel-rise timing is proper. Heel-rise was proper.
[0184] Prescription: Patient was now briefed with safety instructions and was asked on week
1 to wear the device at home for 1 hour a day (and walk in accumulative about 10-15
minutes a day as part of his daily activities at home). Patient was instructed to
increase daily wearing time of the device by 10-15 minutes every week for the initial
3 weeks, reaching 90 minutes wearing time with the device every day (about minutes
of accumulative walking a day). Patient was monitored in the treatment center 3 weeks
after his first visit, 6 weeks after his first visit, and 3 months after his first
visit.
[0185] Treatment course: Patient reported a significant reduction in "giving-ways" already
after 3 weeks of treatment, in gait lab velocity was higher; step length and single
limb support were increased in the left and in the right knee. In the first follow-up
meeting the BPs convexity was increased to "C" under the hind-foot and the fore-foot
both in the left and in the right leg. After 6 weeks of treatment, the patient was
also given designated exercise to incorporate with the device. After 3 months of treatment,
patient returned to play soccer as an amateur. The convexity of all 4 BPs was gradually
increased. The daily usage of the device was increased until reaching up to 3 hours
daily wearing time both indoors and outdoors.
EXAMPLE 4: Hip Osteoarthritis
[0186] A 72 years old female patient presented to the clinic with pain, difficulty in walking,
difficulty ascending stairs and difficulty in prolonged standing.
[0187] The patient reported having pain in the area of the right greater trochanter and
the inguinal area. The pain was felt during walking, getting up from a seated position
and while ascending stairs. The patient had the pain for the past year and reported
it was gradually worsening. She also described stiffness around the right hip area
after getting up in the morning lasting for 15 minutes.
[0188] Physical Examination: On observation the patients' knees are in a mild valgus alignment
and she stands with an anterior pelvic tilt (flexion deformity of the right hip).
Internal rotation of the right hip in neutral position was full but painful at the
end of range. Right hip internal rotation in 90 degrees of flexion was 15 degrees
and painful (30 degrees in the left hip). FADIR test was positive on the right and
negative on the left. Right hip extension showed limited range of motion in comparison
to the left (10 degrees and 25 degrees respectively). Clinical gait assessment revealed
increased pelvic posterior rotation on the right during late stance. The patient reported
she feels the inguinal pain during both heel strike and late stance. She rated the
pain as 4/10 on VAS.
[0189] Imaging and Gait lab: X-rays in the supine position revealed right hip joint space
narrowing with subchondral bone sclerosis and subchondral bone cysts. The left hip
showed joint space narrowing to a lesser degree. Gait lab data provided: gait velocity
of 91 cm/sec, right step length: 55 cm., left step length 52.3 cm., right single limb
support 37.3% and left single limb support 39.1%. In/ out toeing angle of the foot
was -3.1 degrees on the right (indicating 3.1 degrees of in- toeing) and +5 degrees
on the left (indicating 5 degrees of out-toeing) (see table 5 for gait lab data) .
Table no. 5: Patient Gait Parameters
Visit |
Velocity (cm/sec) |
Left step length (cm) |
Right Step length (cm) |
Left Single Limb Support (in % of step cycle) |
Right Single Limb Support (in % of step cycle) |
Left In/Out Toeing (+ out - in) |
Left In/Out Toeing (+ out - in) |
1st (initial) |
91.0 |
55.0 |
52.3 |
39.1 |
37.1 |
-3.1 |
+5 |
2nd (first follow-up) |
95 |
56.1 |
54.5 |
39.0 |
38.0 |
-2.7 |
+6.1 |
3rd (second follow-up) |
100 |
56.5 |
54.9 |
39.3 |
38.5 |
-1.3 |
+6.5 |
4th (third follow-up) |
108 |
56.4 |
55.3 |
39.4 |
38.6 |
-1.2 |
+6.4 |
[0190] Treatment course: BP's with B (medium) convexity and "soft" resilience/hardness were
connected and fixed under the hind-foot and fore -foot of the left and right footwear.
A 100 g spacer (disc shaped) of 3 mm height was attached and fixed between the outsole
and the posterior protuberance under both legs. In order to maintain the anterior
protuberance at the same height so as not to create a plantar flexed position a hard
spacer and a soft spacer were introduced and fixed between the anterior protuberance
and footwear both under legs.
[0191] Balancing: The patient's device was calibrated and fine tuned during repeated clinical
gait assessments with the device (footwear). During this process care is taken to
reduce the eversion and inversion during heel strike, loading response, mid-stance
and toe-off.
[0192] Pain: In order to reduce the pain in the right inguinal area during heel strike the
posterior Rt. BP was calibrated 3 mm posterior and 2 mm medially. The patient reported
that pain was reduced to a 2/10 (from a level of 4/10). To reduce the pain further
the posterior right BP was calibrated and fixed in a new position (1 mm posteriorly
and 1 mm medially). The patient reported that pain during heel strike was reduced
to a mild discomfort. However, the foot seemed to be inverting during heel strike
phase so the posterior Rt. BP was calibrated and fixed 1 mm lateral to its previous
position. As a result the pain was decreased to a level of 1/10 while walking with
the system. The left system was balanced and further calibrated to minimize eversion
and inversion through all phases of the stance.
[0193] Heel-Rise Timing: The patient was asked to walk 20 meters in order to see if the
heel-rise was timed in the gait cycle. It was noted that the patient had a late heel-rise
in both the right and the left leg. In order to correct this, another 2mm hard spacer
was fixed between the right anterior BP and the right boot, thus bringing the right
ankle into a more plantar flexed position. The patients gait was reassessed and the
heel rise observed on the right was normalized. The patient reported at this point
that she felt a significant decrease in the pain during late stance (0.5 on VAS).
This is allegedly because the dorsi-flexion created reduced the need for hip extension
at this phase of gait. Thus, the patient was better supported by the footwear. In
order to correct the timing of the left heel-rise another 2mm hard spacer was fixed
between the left anterior BP and the left boot, thus bringing the left ankle into
a more plantar flexed position. The patient's gait was reassessed: left heel rise
was normalized.
[0194] Treatment Plan: The patient was briefed about the safety instructions of the device
and instructed to start the treatment with a total wearing time of 30 minutes a day
for the first week of the treatment (accumulative weight bearing time was defined
as 15% of total wearing time, i.e. 5 minutes). She was asked to increase the total
wearing time of the device by 10 minutes a week for the first 6 weeks of the treatment,
maintaining the relative 10% of accumulative weight bearing time. The patient was
seen for follow up consultations 6 weeks after the initial consultation, 3 months
after the initial consultation and 5 months after the initial consultation.
[0195] Treatment Progression: As described above during the initial consultation, the patient
had an immediate reduction in pain while walking with the calibrated device. On the
first follow up consultation the patient reported that she found house work much easier
than previously and less painful. Follow up Gait lab results indicated an increase
in velocity, step length and single support in both legs as well as an improvement
in the symmetry of gait. The patient was asked to continue to add to the total wearing
time at a rate of 15 minutes per week while increasing the accumulative weight bearing
time to 15% of the total wearing time.
[0196] On the second follow up the patient reported that morning stiffness was substantially
reduced and she found that walking outside without the device is easier. She reported
she currently feels the pain around the greater trochanter when she walks for over
45 minutes (VAS 1-2/10). The pain in the inguinal area was very infrequent. By then,
the patient was wearing the device for 4 hours a day and functioning indoors freely
(Gait lab data provided in table no. 5). The posterior BP's on both devices were changed
to C convexity (more convex) in order to provide a greater challenge for her neuromuscular
system. Since C convexity protuberances are higher than the B convexity protuberances
(which remained unchanged in the anterior protuberance on both the device on the left
foot and the device on the right foot) a hard spacer was introduced between the outsole
and the base of the anterior protuberance on both the right and the left boots. This
was done without changing the location of the anterior protuberances. Following this
calibration, the patient's gait was reassessed including balanced calibration (as
explained above). The patient reported she had no pain or discomfort with the new
calibration. She was instructed to maintain the overall treatment time.
[0197] After the initial 5 months the patient was seen twice a year for follow up consultations
and monitoring. Her walking abilities and pain improved dramatically.
EXAMPLE 5: Left Total Knee Replacement and Right Knee OA
[0198] A 71 years old male presented to the treatment center 3 months after undergoing a
left total knee replacement.
[0199] Case History: The patient suffered from OA of the left knee for 5 years prior to
undergoing an elective TKR. He suffered right knee medial and anterior pain for the
last 2 years. The patient reported that he had physiotherapy for 3 months post surgery
but he feels weak in the injured leg. He also reported of an increase in medial pain
in the right knee since the surgery which he rated as 6/10 at its worst.
[0200] Physical Examination: On observation the patient bears more weight on the right leg,
quadriceps and triceps surae on the left are atrophied compared to the right. Assessment
of range of motion in the supine position revealed full extension of the right and
left knees. Flexion on the right was 110 degrees and 120 on the left with left medial
knee pain produced at the end of range. Palpation did not produce any pain in the
left knee and produced medial joint line tenderness on the right knee. During clinical
gait assessment the left knee was observed to have inadequate flexion during swing
phase which resulted in circumduction of the hip as compensation. During stance phase
the left knee did not fully extend and was kept at about 10 degrees flexion. The patient
reported medial knee pain in the left knee was felt mainly during heel strike and
loading phases. He rated that pain as 4/10 on VAS.
[0201] Imaging and Gait lab: X-rays in the supine position (regrettably X-rays in standing
were unavailable at the initial consultation) showed the TKR prosthesis was well positioned
and did not show any signs of infection or loosening. The left knee X-rays revealed
mild-moderate medial joint space narrowing. Kellgern-Lawrence rating was impossible
since X-rays were in supine. Gait lab data revealed: a gait velocity of 68 cm/sec.,
left single limb support: 32.3%, right single limb support 37.2%, left step length
51.1 cm. and right step length was 46.5 cm. (see table 6 for detailed gait lab data).
Table 6: Patient Gait Parameters
Visit |
Velocity (cm/sec) |
Left step length (cm) |
Right Step length (cm) |
Left Single Limb Support (in % of step cycle) |
Right Single Limb Support (in % of step cycle) |
1st (initial) |
68.0 |
51.1 |
46.5 |
32.3 |
37.2 |
1st (initial) With the Device |
80.0 |
55.2 |
49.5 |
35.1 |
36.2 |
1st (initial) Barefoot retest |
74.2 |
55.0 |
48.1 |
33.8 |
36.9 |
2nd (first follow-up) |
79.3 |
58.1 |
56.3 |
35.8 |
37.9 |
2nd (first follow-up) With the Device |
88.6 |
59.4 |
58.1 |
36.7 |
38.3 |
2nd (first follow-up) Barefoot retest |
85.6 |
58.8 |
58.0 |
36.4 |
37.9 |
3rd (second follow-up) |
103.2 |
60.9 |
59.2 |
38.7 |
38.0 |
3rd (second follow-up) With the Device |
115.3 |
62.3 |
60.9 |
38.9 |
38.3 |
3rd (second follow-up) Barefoot retest |
110.4 |
61.7 |
60.7 |
38.1 |
38.9 |
4th (third follow-up) |
115.9 |
62.5 |
61.9 |
38.2 |
38.1 |
4th (third follow-up) With the Device |
117.2 |
63.0 |
62.4 |
37.9 |
38.0 |
[0202] Therapy: BP's with B convexity and "soft" resilience were attached and fixed under
the hind-foot and the fore-foot of the left device. BP's with C convexity and "soft"
resilience were attached and fixed under the hind-foot and the fore-foot of the right
foot. Since C convexity BP's are higher than B convexity Protuberances, and since
gait lab data showed the patient has reduced single limb support on the left leg,
3 hard spacers were inserted and fixed under the anterior and posterior BP's of the
left foot. This calibration, called "off-loading", induces easier swing of the contra-lateral
leg by increasing the height of the BP's in the affected leg. In this case the left
leg is 3 mm. higher than the right leg.
[0203] In order to increase proprioceptive input, a 100 g disc was inserted between the
shoe and the posterior B.P. of the left and right systems. This brought both ankles
to a slightly plantar flexed position. This was not corrected since the left knee
failed to reach full extension during stance the plantar flexion is supports it.
[0204] Balancing: The patients system was calibrated and fine tuned during repeated clinical
gait assessments with the device. During this process care is taken to reduce the
eversion and inversion during heel strike, loading response, mid-stance and toe-off.
[0205] Pain: In order to reduce the pain in the right medial knee the posterior BP of the
right system was calibrated 2 mm. laterally and fixed in the new position. The patient
then reported that his pain has reduced to 3/10 while walking with the device. The
posterior protuberance of the right system was therefore calibrated another 2 mm.
laterally and fixed in the new position. When the patient walked with the device again
the pain was reduced to 1/10. The posterior protuberance of the right device was calibrated
and fixed a further 1 mm. laterally but clinical gait assessment showed that the right
foot was now excessively pronated and the patient did not report any further decrease
in pain. The posterior BP of the right system was therefore recalibrated to its previous
position and fixed there. Clinical gait assessment showed that the eversion of the
right foot was now at an acceptable amount and the patient rated the medial knee pain
as 1/10.
[0206] In order to improve the extension of the left knee during stance the posterior BP
of the left footwear was calibrated and fixed 5 mm. anterior to its neutral position.
The knee seemed to be more extended during stance phase and the gait velocity was
increased. The patient reported that walking with the footwear is much more comfortable
than walking with regular sneakers.
[0207] Heel-Rise Timing: The patient was asked to walk 20 m in order to confirm that he
was still balanced and the heel-rise is well timed in the gait cycle. The clinical
gait assessment showed an early heel rise on the left leg. In order to correct this,
a hard spacer was introduced and fixed under the posterior BP in the left footwear.
Repeated gait assessment showed that the left heel-rise had been normalized.
[0208] Gait lab Retest: Once the balancing process was completed the patient performed another
gait lab test with the device. The results of this test were significantly better
than the baseline results. Gait velocity increased to 80 cm/sec., left single limb
support: 35.1%, right single limb support 36.2%, left step length 55.2 cm. and right
step length was 49.5 cm. (see table 6 for detailed gaitlab data). The data from this
test showed gait velocity was 74.2 cm/sec., left single limb support: 33.8%, right
single limb support 36.9%, left step length 55.0 cm. and right step length was 48.1
cm. (see table 6 for detailed gaitlab data). These results show that the patients
gait is much improved with the device and that some of the improved motor control
(for example the improved left knee extension during stance) is retained for at least
a short period of time.
[0209] Treatment Plan: The patient was briefed with safety instructions and instructed to
start the treatment by wearing the device for an hour and a half daily on the first
week of the treatment. Accumulated weight bearing time was set at 10% of the total
time of wearing the footwear. Thus out of the hour and a half he was supposed to be
in weight bearing for an accumulative period of 9-10 minutes. The patient was asked
to increase the total wearing time of the footwear by 15 minutes on the second week,
maintaining the relative 10% of accumulated weight bearing time. The patient was seen
for follow up consultations 2 weeks after the initial consultation, 6 weeks after
the initial consultation, 3 months and again 6 months after the initial consultation.
[0210] Treatment Progression: As mentioned above the patient felt an immediate pain relief
in the right knee and had better knee extension on the left when walking with the
footwear during the initial consultation. During the second follow up consultation
the patient reported that he enjoyed walking with the footwear and found it easier
and less painful to walk and function with it. The pain in the right knee was not
constant now though its peak level did not decrease (VAS 6/10). Gait lab test revealed
an increase in left single limb support (from 32.3% to 33.9%) and an increase in right
step length (from 46.5cm. to 47.3 cm., for gait lab details see table no. 6). Due
to the improvement and due to the fact that differences between right and left single
limb support and step length were still significant the calibration of the right and
the left boots was left unchanged. The patient was asked to increase the total wearing
of the footwear by 15 minutes per week. In addition he was instructed to walk continuously
with the device indoors, starting from 2 minutes of continuous walking and increasing
by 2 minutes every week.
[0211] On the second follow up the patient reported that he reached 2.5 hours of total wear
time, out of which he had an accumulative weight bearing time of 15-20 minutes. In
addition, he reported that he had much less pain in the right knee while performing
daily activities without the footwear (VAS 3/10). Gait lab data revealed further increases
in gait velocity (79.3 cm/sec.), left single limb support (35.8%) and right and left
step length ( 56.3 cm. and 58.1 cm. respectively). These results represent a marked
improvement in gait symmetry and mirror the patients' report of improvement in pain
level and functional level. The calibration was therefore changed to C convexity on
the anterior and posterior BP's of the left device. The hard spacer on the posterior
protuberance of the left device was removed since the knee extension on barefoot gait
was now full. The calibration in the right device remained unchanged. The patients
gait was reassessed with the device and there were no gait deviations observed. The
patient reported he felt comfortable walking with the new calibration and did not
experience any symptoms. A gait lab test with the footwear was performed and showed
encouraging results, as did a barefoot gait lab retest (see detailed results in table
6). The patient was asked not to increase wearing time as to allow for a customization
process to take place. He was told to gradually increase total wearing time to 4 hours
and increase accumulative weight bearing time to 15% of the total wearing time. In
addition he was instructed to increase his indoor walking gradually to 15 minutes.
[0212] The patient continued his gait improvement and pain relief. On the third follow up
consultation he was allowed to perform outdoor walking with the Device. Gait lab results
are shown in table 6. The patient was seen again for a follow up consultation 6 months
after the initial consultations in which he reported he had no pain or weakness in
the left leg and had only mild (1-2/10) occasional pain in the medial aspect of the
right knee. After this the patient was asked to come in for follow up consultations
twice a year.
EXAMPLE 6: Post Left Total Hip Replacement
[0213] A 75 years old male is presented to the treatment center 3 weeks following an elective
right total hip replacement.
[0214] Case History: The patient had left hip pain for four years prior to surgery, with
a significant increase in pain and functional limitations during the year prior to
surgery. During the surgery a cemented total hip prosthesis was inserted. He was told
to bear full weight on the operated leg but was unable to do so due to pain and fear
that it will not support him. At the time he was first seen he is ambulating with
a walker and confined to indoor walking only. Pain was felt around the surgical wound
and deep in the groin area (VAS 5/10).
[0215] Physical Examination: On observation in standing the patient bears significantly
more weight on the right leg and stands in forward flexion of the trunk. Ranges of
motion measured in supine were: hip flexion- left: 80 degrees, right: 105 degrees.
Internal rotation in neutral position- left: 15 degrees, right: 25 degrees. During
clinical gait assessment the patient had great difficulty walking without the walker
so the assessment was very minimal. The patient rated the pain as 5/10 on VAS and
described the left leg as being very weak
[0216] Imaging and Gait lab: X-rays showed the prosthesis was in good position without any
signs of loosening or infection. The right hip showed mild joint space narrowing.
Gait lab results showed gait velocity was 37 cm/sec., left step length- 21cm., right
step length- 25cm., left single limb support-19.0%, right single limb support-42.1%.
[0217] Therapy: BP's with A level of convexity (low level) were attached and fixed under
the hind-foot and fore-foot of the left device. BP's with C level (high level) of
convexity were attached and fixed under the hind-foot and fore-foot of the right device.
A 100 g spacer (disc) was inserted and fixed between the outsole and the posterior
BP's of the left and the right footwear in order to increase the proprioceptive input
during swing and improve pelvic muscular control during stance. In order to support
the patient in the forward flexed position (and correct the plantar flexed position
created by the insertion of the disc in the posterior BP's) 2 hard spacers and a soft
spacer were inserted and fixed between the shoe and the anterior BP's on the left
and the right devices. Since C convexity provides elevated height than convexity A,
balancing was required. Because of the vast difference in single limb support between
the left and right legs there was a need to "off-load" the left leg (for details about
the rationale of offloading see previous examples). For that purpose 2 hard spacers
were inserted between the outsole and the anterior protuberance of the left boot.
2 additional hard spacers were inserted between the outsole and the base of the anterior
BP of the left device.
[0218] Balancing: The patient's footwear was calibrated and fine tuned during repeated clinical
gait assessments with the device. During this process care is taken to reduce the
eversion and inversion during heel strike, loading response, mid-stance and toe-off.
[0219] Pain: In order to decrease the pain in the left hip during weight bearing, the posterior
protuberance of the left footwear was calibrated and fixed 6mm posteriorly and 4mm
medially to its previous position. The patient reported that pain decreased to a level
of 4/10 on VAS and he found that bearing weight on the leg is now, easier. The posterior
left BP was calibrated and fixed a further 2mm posteriorly and 2mm medially and the
patient reported another decrease in pain level (3/10) and comfort in weight bearing.
During clinical gait assessment it was clear that the gait velocity has increased
and weight bearing on the left leg was performed with more movement into hip extension.
This process continued until the posterior left BP was fixed 15mm posteriorly and
8mm medially to its original position. The patient had a marked improvement in pain
(VAS 2/10) and symmetry of gait. The same process was repeated with the right device
(i.e. the position of the posterior device was recalibrated and fixed to a more posterior
and medial position and the patients' gait was reassessed). At the end of the calibration
of the right boot, the posterior device was 9mm posteriorly and 6 mm medially to its
original position.
[0220] Heel-Rise Timing: The patient was asked to walk 20 m in order to confirm heel-rise
is well timed in the gait cycle. An early heel-rise in the right foot was evident.
In order to correct this, the soft spacer was removed from between the anterior BP
and the shoe of the right footwear. A clinical gait assessment was performed and it
was noted that the heel-rise in the right leg had been normalized.
[0221] Gait lab Retest: Once the balancing process was completed the patient performed another
gait lab test with the device. The results of this test were significantly better
than the baseline results. Gait velocity increased to 55.0 cm/sec., left single limb
support: 27.3%, right single limb support 39.1%, left step length 37.2 cm. and right
step length was 39.3 cm. (see table 7 for detailed gait lab data). The data from this
test showed gait velocity was 49.1 cm/sec., left single limb support: 25.6%, right
single limb support: 41.6 %, left step length 32.7cm and right step length was 39.3cm.
(See table 7 for detailed gait lab data). These results show that the patients gait
is much improved with the device and that some of the improved motor control (for
example the bearing more weight on the left leg thus increasing right step length)
is retained for at least a short period of time.
Table 7: Patient's Gait lab Parameters
Visit |
Velocity (cm/sec) |
Left step length (cm) |
Right Step length (cm) |
Left Single Limb Support (in % of step cycle) |
Right Single Limb Support (in % of step cycle) |
1st (initial) |
37.0 |
21.0 |
25.0 |
19.0 |
42.1 |
1st (initial) With the Device |
55.0 |
37.0 |
40.5 |
27.3 |
39.1 |
1st (initial) Barefoot retest |
49.0 |
32.7 |
39.3 |
25.6 |
41.6 |
2nd (first follow-up) |
73.1 |
42.0 |
47.0 |
33.3 |
39.4 |
2nd (first follow-up) With the Device |
92.8 |
52.3 |
56.6 |
35.1 |
39.0 |
2nd (first follow-up) Barefoot retest |
80.3 |
46.9 |
49.3 |
34.8 |
39.6 |
3rd (second follow-up) |
116.0 |
64.1 |
62.7 |
37.9 |
40.4 |
3rd (second follow-up) With the Device |
117 |
65.3 |
64.8 |
37.1 |
39.1 |
3rd (second follow-up) Barefoot retest |
115.6 |
64.8 |
64.6 |
37.6 |
39.3 |
[0222] Treatment Plan: The patient was briefed about the safety instructions and instructed
to start the treatment by wearing the device for a total time of one hour for every
day of the first week, out of which a total of 5% to 10% should be spent in weight
bearing activities. Thus accumulated weight bearing time should be 3-6 minutes. The
patient was seen for follow up consultations 10 days after the initial consultation,
3 weeks after the initial consultation, 5 weeks after the initial consultation and
3 months after the initial consultation.
[0223] Treatment Progression: At the end of the initial calibration process the patient
immediately felt less pain and his ambulation was much easier with the footwear. In
the first follow up he reported that pain was decreased while walking with the footwear
(to 1/10 on VAS). He also reported that when he was walking with the footwear he did
not need the support of the walker. Gait without the footwear was also significantly
better with pain level rated at a maximum of 3/10. Gait lab results showed a large
improvement in barefoot gait. Gait velocity was 73.0 cm/sec., left single limb support:
33.3%, right single limb support 39.4%, left step length 42.0 cm. and right step length
was 47.0 cm. (see table 7 for details of barefoot gait lab retest). Due to the improvement
and due to the fact that differences between right and left single limb support and
step length were still significant the patient still needed "off-loading" and asymmetrical
level of perturbation. The anterior and posterior BP's of the left footwear were therefore
changed to a B level of convexity. Since B level convexity is higher than the A level
convexity, one hard spacer was removed from the posterior BP. This was done without
changing the position of the BP. A hard spacer was removed from the anterior protuberance
as well, without changing its position. Clinical gait assessment revealed the patient
had an early-heel rise in the left leg. In order to correct this one soft spacer was
removed from the anterior left BP and the patients' heel-rise timing became normalized.
The patient was asked not to increase the total wearing time for 3-4 days to allow
his neuromuscular control to get accustomed to the new calibration. After the first
4 days the patient was asked to increase the total wearing time of the footwear by
15 minutes a week and maintain 10% of accumulative weight bearing time.
[0224] On the second follow up the patient reported that he no longer needed any type of
walking aid. His pain level decreased to 1/10 and he reported he had the device on
for 2 and half hours every day. During that time he ambulates freely around the house.
Gait lab data showed velocity was now 116 cm/sec, left single limb support: 37.9%,
right single limb support 40.4%, left step length 64.1 cm. and right step length was
62.7 cm. (see table 7 for details of barefoot gaitlab retest). The anterior and posterior
BP's of the left device were therefore changed to a C level convexity. Since C level
convexity is higher than the B level of convexity which the left the BP's had in the
last calibration one hard spacer was removed from the posterior protuberance. This
was done without changing the position of the BP. A hard spacer was removed from the
anterior BP as well, without changing its position. Clinical gait assessment showed
no gait deviations and the patient reported he had no pain or discomfort. Gait lab
data with the device and a barefoot retest are provided in table. 7. The patient was
requested to increase the total wearing time of the footwear by 20 minutes a week.
He was instructed that within this time frame he should perform one period of continuous
indoor walking starting with 10 minutes and increasing by 2 minutes per week. In the
follow up consultation conducted 3 months after the initiation of the treatment the
patient reported he was pain free and has worked the overall wearing time of the footwear
to 5 hours a day. During that time he performed a 25 minute period of continuous indoor
walking (see table 7). There were no changes in the calibration made in this follow
up consultation. The patient was instructed to continue with the same treatment plan
and cone for another follow up consultation in 5 months.
EXAMPLE 7: Right Bimalleolar Ankle Fracture (Open Reduction and Internal Fixation)
[0225] A 37 years old male is presented to the treatment center 10 weeks after a bimalleolar
ankle fracture treated by an open reduction and internal fixation.
[0226] Case History: The patient has broken his right ankle during a basketball game 10
weeks ago in an inversion mechanism. He was operated that night and was recommended
to maintain the leg in non-weight bearing for two weeks. Following the removal of
the staples, partial weight bearing was recommended. The patient was instructed by
the treating surgeon to increase weight bearing as tolerated and was referred to physiotherapy.
He needed a walking stick for outdoors walking. Walking for over 5 minutes was difficult
and painful (4/10 on a VAS). The pain was increasing when climbing up or down stairs
(5/10 and 6/10 respectively).
[0227] Physical Examination: On observation there was a moderate edema around the right
foot and ankle. The patient was bearing more weight on the left leg. Ranges of motion
measured by a hand held goniometer revealed right dorsiflexion- 5 degrees, left dorsiflexion-
15 degrees, right plantar-flexion- 45 degrees, left plantar-flexion- 75 degrees. Palpation
of the ankle produced mild tenderness in the anterior joint line and around the lateral
malleolus. During clinical gait assessment it was evident that the patient had insufficient
dorsiflexion in the right ankle. This led to a shorter stance on the right and reduced
the swing phase of the left leg. The patient reported anterior and lateral right ankle
pain during mid and late phases of stance. He rated the pain as 5/10 on a VAS.
[0228] Imaging and Gait lab: X-rays of the right ankle showed the fracture to be well positioned
and fully calloused. There were no apparent signs of ankle or subtalar joint damage.
Gait lab data showed gait velocity of 65.1 cm/sec., left step length- 43.8cm. , right
step length-50.2cm, left single limb support- 43.2 %, right single limb support- 31.7%.
[0229] Therapy-Balancing: The patient's footwear was calibrated and fine tuned during repeated
clinical gait assessments with the device. During this process care is taken to reduce
the eversion and inversion during heel strike, loading response, mid-stance and toe-off.
[0230] Pain: BP's with a B level convexity and "soft" hardness were attached and fixed under
the hind-foot and fore-foot of the right boot. In order to reduce the pain during
midstance of the right leg (believed to be caused by the limited dorsiflexion) two
soft spacers were inserted and fixed between the posterior right BP and the outsole.
This brought the right ankle to a slightly plantar-flexed position. In addition, this
also created a certain a degree of "off-loading" of the right leg (see previous examples
for details of "off-loading"). BP's with C level convexity and hard resilience were
attached and fixed to the hind-foot and fore-foot of the left footwear. Since BP's
with C level convexity are higher than BP's with B level convexity, the "off loading"
of the right leg was now lost. Therefore, two hard spacers were inserted and fixed
between the shoe and the right posterior protuberance, additional two hard spacers
were inserted and fixed for the right anterior BP. The patients' gait was clinically
assessed and showed increased velocity, longer stance period of the right leg and
improved step length symmetry. The patient reported that the right ankle pain was
now at a level of 2/10 pain. In order to decrease the right ankle pain further the
posterior right BP was calibrated and fixed 3mm anteriorly to its original position.
The patient reported that his right ankle pain level was now 1/10. A further anterior
calibration of 2mm of the right posterior BP did not produce any further improvement
in either gait quality or pain level. Therefore, the right posterior BP was calibrated
and fixed 2mm back to its previous position.
[0231] Heel-Rise Timing: The patient was asked to walk 20 m in order to confirm that he
was still balanced and the heel-rise is well timed within the gait cycle. There were
no apparent gait deviations regarding heel-rise timing in the left leg or the right
leg.
[0232] Treatment Plan: The patient was briefed regarding the safety instructions. He was
told to wear the device for a total of 45 minutes a day on every day of the first
week. Out of that total time he was asked to perform weight bearing activities for
an accumulative amount of 9-10 minutes (20% of the total wearing time). The patient
was instructed to increase the total wearing time of the footwear by 10 minutes each
week of the treatment, while maintaining 20% of accumulative weight bearing time.
The patient was seen for follow up consultations in the Treatment center 2 weeks after
the initial consultation, 5 weeks after the initial consultation, 3 months after the
initial consultation and half a year after the initial consultation.
[0233] Treatment Progression: As afore mentioned, the patient had significantly reduced
pain and found walking much easier with the footwear during the initial calibration
process. On the first follow up consultation the patient reported that he found walking
indoors without the footwear easier and less painful than before (pain level for indoor
walking 2/10) though he still needed to use the walking cane for longer, outdoor walks.
He increased the total wearing time of the footwear to an hour and 15 minutes. Gait
lab data showed gait velocity increase to 78.0 cm/sec, right step length and left
step length have increased and the symmetry in step length was better (left-48.9cm.
right-52.3 cm.). The single limb support values also improved and had better symmetry
(left- 41.0% right-33.2 %). Due to the positive effects on pain level and gait parameters
the calibration was left unchanged. The patient was asked to increase the total wearing
time by 15 minutes each week while maintaining the relative 10% of accumulative weight
bearing time.
[0234] On the second follow up consultation the patient reported he found walking outdoors
much less painful (pain level decreased to 1-2/10) and ceased to use the walking cane.
He was wearing the device for 2 hours a day and found walking with it, painless. Gait
lab parameters were: velocity-105.5 cm/sec. left step length 54.3cm, right step length-57.1
cm left single limb support- 39.5%, right single limb support- 37.8%. Due to the pain
decrease and the vast improvement on gait lab parameters the "offloading" and the
asymmetry in perturbation was thought to be unnecessary. The anterior and posterior
BP's of the right device were changed from B level convexity to C level convexity.
The soft spacers placed between the outsole and the base of the posterior right BP
were removed and then the BP was fixed to the same position. The patients gait was
reassessed and the patient reported that he felt mild pain (1/10 on a VAS) during
the late stance phase. In order to relieve this pain, the spacer was removed from
beneath the anterior right protuberance. The protuberance was fixed back to its position.
This brought the right ankle to a slightly plantar-flexed position. The patient then
reported that he had no pain in the right ankle when walking with the device. The
patient was then instructed to continue with the current total treatment time for
a week so as to allow his neuromuscular control to get accustomed to the new calibration.
Following that week, he was asked to increase the total treatment time by 15 minutes
every week up to a maximum of 4 hours. He was also instructed, after the first week
following the consultation, to go about indoor daily activities as normal when wearing
the footwear.
[0235] On the third follow up the patient reported he did not have any pain in the right
ankle. The gait lab parameters are presented in table 8. BP's with a convexity grade
D were attached and fixed to the anterior and posterior BP's of both the right and
the left devices. The hard spacer was removed from the right posterior protuberance.
Following these changes, all BP's (on both right and left devices) were attached and
fixed to their previous position. Clinical gait assessment with the device did not
reveal any gait deviations and the patient reported he did not have any pain or discomfort.
The patient was allowed to walk outside while wearing the footwear.