Footwear having an outsole for manipulating gait parameters or for improving lower limb pathology

Abstract

The present invention provides an outsole comprising at least one recess located on the ground contact surface or outer surface of the outsole, the recess having (a) a depth of 10% to 95% of the maximum thickness of the outsole, and (b) an area covering 10% to 95% of the entire ground contact surface or outer surface of the outsole.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is an international patent application claiming the benefit of U.S. Patent Application No. 17 / 585,997, filed January 27, 2022, which claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 226,790, filed July 29, 2021, entitled “FOOTWEAR HAVING AN OUTSOLE FOR MANIPULATING A GAIT PARAMETER OR AMELIORATE A LOWER LIMB PATHOLOGY,” the entire contents of which are incorporated herein by reference in their entirety.

[0002] The present invention is particularly directed to footwear that includes at least one lug, the location and configuration of the at least one lug affecting at least one gait parameter. [Background technology]

[0003] Human gait depends on a complex interplay of major parts of the nervous, musculoskeletal, and cardiopulmonary systems. An individual's gait pattern is influenced by musculoskeletal structure, posture, diseases affecting musculoskeletal structure, neurological factors affecting musculoskeletal structure and posture, age, personality, mood, and sociocultural factors.

[0004] Preferred walking speed in older adults is a highly accurate indicator of general health and survival. Safe walking requires intact cognitive and executive control. Gait disorders lead to injuries, falls, disability, loss of personal freedom, and injury, resulting in a significant decrease in quality of life (Pirker W, Katzenschlager R. Gait disorders in adults and the elderly. Wiener Klinische Wochenschrift. 2017 Feb 1;129(3-4):81-95).

[0005] Gait analysis of each component of the three phases of gait is an essential part of the diagnosis of various neurological disorders, various orthopedic disorders, and the evaluation of a patient's progress during rehabilitation and recovery from a neurological disorder, musculoskeletal injury or disease process, or lower limb amputation.

[0006] The boundary between walking and running occurs when a double support period (when both feet are simultaneously on the ground) during the stance phase of the gait cycle transitions to two double lift periods (when neither foot is on the ground) at the beginning and end of the swing phase of gait (Novacheck TF. The biomechanics of running. Gait and Posture 7 (1998) 77-95).

[0007] The gait sequence that occurs can be summarized as follows (Vaughan CL. Theories of bipedal walking: an odyssey. J Biomech 2001;36(2003):513-523): registration and activation of the walking command in the central nervous system, transmission of the locomotor system to the peripheral nervous system, muscle contraction, generation of several forces, coordination of joint forces and moments across synovial joints and skeletal segments, generation of ground reaction forces.

[0008] A normal forward step consists of two phases: stance and swing. Stance phase occupies 60% of the gait cycle, during which one leg and foot bears most or all of the body weight. Swing phase occupies only 40% of the gait cycle, during which one foot is not in contact with the walking surface and the body weight is supported by the other leg and foot (Loudon J et al., The clinical orthopedic assessment guide. 2nd ed. Kansas: Human Kinetics, 2008. p. 395-408).

[0009] Throughout the two-phase cycle, both feet are on the ground simultaneously for approximately 25 percent of the time. This portion of the cycle is called the double support period. The gait cycle includes phases of stance and swing and a combination of open and closed chain activities (Shultz SJ et al., Examination of musculoskeletal injuries. 2nd ed, North Carolina; Human Kinetics, 2005. p55-60).

[0010] Sports injuries are an inevitable part of sports. Understanding the challenge in injury prevention is to recognize all the risk factors and musculoskeletal patterns for specific injuries in each sport and to create better prevention strategies. One of the key elements in injury prevention and post-injury rehabilitation is proprioception and neuromuscular control. Such control can be achieved through gait manipulation.

[0011] There is a need for devices and methods that can manipulate gait, specifically guide lower extremity muscles, treat neurological disorders, treat and reduce pain originating from the lower extremities, treat orthopedic disorders, improve neurological and muscle control, and / or improve / reduce these and other outcomes related to the sensory system, motor system, and / or overall movement, walking, and / or running. Summary of the Invention

[0012] In one embodiment, the present invention provides an outsole comprising at least one recess located on the ground contact surface or outer surface of the outsole, the recess having (a) a depth of 10% to 95% of the maximum thickness of the outsole, and (b) an area covering 10% to 95% of the entire ground contact surface or outer surface of the outsole.

[0013] In one embodiment, the perimeter of at least one recess defines a base adapted to be enclosed within the one or more protrusions. In one embodiment, the outer contour of the one or more protrusions and the outer contour of the outsole form a continuous curve. In one embodiment, at least 50% of the base area of ​​the one or more protrusions is defined by at least one recess. In one embodiment, the base of a single protrusion occupies at least 60% of the area of ​​a single recess, and a first perimeter of the base of the single protrusion is adapted to match a second perimeter of the single recess.

[0014] In one embodiment, each of the one or more protrusions comprises an apex and a base, the apex being at least 10% higher than a maximum depth of the at least one recess, and the one or more protrusions are adapted to be removably attached to the at least one recess / depression / cavity. In one embodiment, the one or more protrusions are two protrusions.

[0015] In one embodiment, the ground surface of the one or more protrusions extends from the at least one recess when the one or more protrusions are disposed in the at least one recess.

[0016] In one embodiment, a rear portion of the at least one recess is adapted to mate with the rear lug and a front portion of the at least one recess is adapted to mate with the front lug. In one embodiment, the outsole has a rear recess adapted to mate with the rear lug and a front recess adapted to mate with the front lug.

[0017] In one embodiment, the outsole has a Shore hardness of 20Sh-00 to 80Sh-D. In one embodiment, the outsole further includes a layer in contact with at least a portion of the at least one recess. In one embodiment, the layer has a Shore hardness of 20Sh-A to 90Sh-D.

[0018] In one embodiment, the layer has a Shore hardness at least 5% greater than the Shore hardness of the outsole.

[0019] Some aspects of the present invention relate to a footwear or footwear kit for manipulating gait parameters, comprising an outsole according to any one of the embodiments disclosed herein, further comprising two curved protrusions protruding from the ground contact surface or outer surface of the outsole and adapted to be removably attached to the at least one recess, each protrusion having a different curved outer contour.

[0020] In some embodiments, the two curved protrusions are asymmetric. In some embodiments, the two curved protrusions are defined by various arches of different radii that meet each other. In some embodiments, the outer contour of at least one of the two curved protrusions and the outer contour of the outsole form a continuous curve. In some embodiments, each curved protrusion comprises a portion connectable to a recess and a ground contact portion, and the portion connectable to the recess is harder than the ground contact portion.

[0021] In some embodiments, each protrusion differs with respect to at least apex position, prominence, Shore hardness, or any combination thereof. In some embodiments, the base of a single protrusion occupies at least 60% of the area of ​​a single recess, and a first perimeter of the base of the single protrusion is adapted to match a second perimeter of the single recess.

[0022] In some embodiments, for each protrusion, the location of at least the apex is determined based on at least one gait and / or balance parameter of the subjects measured for the subject group. In some embodiments, the at least one gait parameter is selected from foot alignment, knee alignment, speed, swing and stance phases, double support time, ground reaction force, impulse, propulsion during habitual gait, knee alignment, center of pressure, symmetry, gait speed, step time, step length, stride length, step width, foot angle, and boundary between walking and running. In some embodiments, the subject group is determined as subjects having at least two common characteristics selected from age, sex, foot size, gait behavior, and pathology. In some embodiments, the subject group is defined as subjects having 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or any range of numbers therebetween, defects in a common gait parameter. In some embodiments, subjects having a common gait behavior are subjects having at least two similar gait parameters. In some embodiments, for each protrusion, a curvature of the protrusion is determined based on at least one gait and / or balance parameter of the subjects measured for the group of subjects. In some embodiments, for each protrusion, a contour of the base of the protrusion is determined based on at least one gait and / or balance parameter of the subjects measured for the group of subjects.

[0023] The present invention will be understood and more fully appreciated from the following detailed description taken in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0024] [Figure 1A-1D] 1A-1D are diagrams of footwear, assembled footwear, and two kits according to some embodiments of the present invention. [Figure 2A-2C] 1A-1C are bottom views of an outsole and a number of outsoles and lugs, respectively, according to some embodiments of the present invention. [Figure 3A-3B]FIG. 13 is a bottom view of a lug assembled to an outsole according to some embodiments of the present invention. [Figure 4A-4B] 1A-1C are bottom views of a kit and assembled footwear, respectively, including a single lug. [Figure 5A-5B] 1A and 1B are front and inset views, respectively, of an outsole and an outsole receiving a lug, according to some embodiments of the present invention. [Figures 6A-6D] 1A and 1B are bottom and side views, respectively, of an outsole receiving lugs designed based on gait parameters, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Some aspects of the present invention are directed to an outsole of a footwear. The outsole is configured to receive one or more specially designed projections. In some embodiments, the outsole is adapted to receive and secure to one or more projections. In one embodiment, "adapted to receive" is by at least one recess in the outsole. In one embodiment, the outsole may include at least one recess located on the ground contact surface or outer surface of the outsole, having (a) a depth of 10%-95% of the maximum thickness of the outsole, and (b) an area covering 10%-95% of the entire ground contact surface or outer surface of the outsole.

[0026] As used herein, a recess is defined as any open cavity, depression, or the like located on the ground contact or exterior surface of an outsole.

[0027] Some aspects of the present invention are directed to footwear that includes an outsole. The footwear may include additional components, such as an upper, a midsole, an insole, attachable and / or removable lugs, etc.

[0028] Some aspects of the present invention are directed to a "kit" that includes footwear and at least one set of one or more separate protrusions. The protrusions are assembled into at least one recess to form an "assembled footwear." In such a case, the assembled footwear includes one or more protrusions secured to an outer surface of an outsole as described herein. Some aspects of the present invention are directed to a "kit" that includes an outsole and an upper shoe portion of the footwear. Some aspects of the present invention are directed to a "kit" that includes an outsole and an upper shoe portion of the footwear and at least one set of one or more separate protrusions.

[0029] In another embodiment, the one or more projections assembled to the assembled footwear are configured to manipulate at least one gait parameter of the subject. In an embodiment described herein, the assembled footwear comprising projections secured to the outer surface of the outsole described herein is configured to manipulate the balance of the subject. In one embodiment, the assembled footwear is configured to manipulate the proprioception, kinesthetic sense, or both of the subject in need of the assembled footwear. In an embodiment described herein, the assembled footwear comprising projections secured to the outer surface of the outsole described herein is configured to treat a subject suffering from a lower limb joint pathology, such as, but not limited to, degenerative joint disease and musculoskeletal trauma of the lower limb. In an embodiment described herein, the assembled footwear comprising projections secured to the outer surface of the outsole described herein is configured to treat other pathologies as described herein.

[0030] In one embodiment, the prefabricated one or more lugs are secured and / or attached to the footwear. In one embodiment, the prefabricated one or more lugs are secured and / or attached to the outsole. In one embodiment, the prefabricated one or more lugs are secured and / or attached to the outsole within the recess. In one embodiment, the assembled one or more lugs are removable from the footwear, the outsole, and / or the recess. In one embodiment, the assembled one or more lugs are replaceable.

[0031] In another embodiment, one or more protrusions assembled into at least one recess may have a therapeutic effect as described herein. Footwear, prefabricated footwear, and kits

[0032] Reference is made to Figures 1A, 1B, 1C, and 1D, which are illustrations of footwear, assembled footwear, and two kits, according to some embodiments of the present invention.

[0033] Footwear, such as footwear 10 shown in FIG. 1A, in accordance with embodiments of the present invention, may include at least an upper 15 and an outsole 50. In some embodiments, outsole 50 includes at least one recess 60 adapted to match or be surrounded by one or more protrusions, such as, for example, protrusions 20 and / or 30 or protrusion 25 shown in FIG. 1D.

[0034] In another embodiment, assembled footwear 100, shown in FIG. 1B, includes footwear 10 and one or more lugs 20 and / or 30.

[0035] In another embodiment, a kit 200 comprising disassembled footwear is shown in FIG. 1C. The kit 200 comprises footwear 10 and one or more sets of lugs 20 and / or 30. In another embodiment, the kit comprises the lugs and the footwear separately. In another embodiment, the disassembled footwear or kit comprises an outsole and an upper shoe portion separately, the upper shoe portion adapted to be assembled to the outsole. In another embodiment, the disassembled footwear or kit comprises an outsole, an upper shoe portion, and lugs separately.

[0036] In another embodiment, a kit 200 is shown in FIG. 1D that includes disassembled footwear having a single protrusion. The kit 200 includes the footwear 10 and a separate single protrusion 25. The single protrusion 25 may be a generally flat protrusion, as shown and described below. Alternatively, the single protrusion 25 is a spherical protrusion (e.g., protrusion 20 or 30). The single spherical protrusion may be assembled to a front portion of the recess 60, a middle portion of the recess 60, and / or a rear portion of the recess 60.

[0037] In another embodiment, the kit 200 may include two or more separate recesses or two generally planar protrusions that assemble into a single recess.

[0038] In another embodiment, the kit or footwear only includes a flat lug or lugs.

[0039] In another embodiment, kit 200 may include two or more sets of alternative lugs that are easily interchanged by the subject. In another embodiment, kit 200 may include footwear 10, a set of functional lugs, such as lugs 20 and 30, and at least one additional lug 25. As used herein, a functional lug is defined as a lug configured to manipulate at least one gait and / or balance parameter of the subject.

[0040] In another embodiment, at least one additional protrusion 25 is assembled into at least one recess 60 for normal walking, standing, or running. Outsole

[0041] Reference is now made to Figures 2A, 2B, and 2C, which are bottom views of an outsole and a plurality of outsoles and lugs, respectively, according to some embodiments of the present invention.

[0042] In another embodiment, outsole 50 includes at least one recess 60 located on the ground contact, bottom, or exterior surface 55 of outsole 50. Outsole 50 may be made from any material known in the art suitable for forming an outsole. In an embodiment, outsole 50 includes a polymer or similar material characterized by a Shore hardness of 20Sh-00 to 80Sh-D.

[0043] In an embodiment, the outsole 50 is made from a single piece having a uniform hardness. For example, the outsole 50 may be obtained by injection, extrusion, molding, pressing, etc. from a single polymer. In another embodiment, the outsole 50 is made from multiple pieces made from different or similar materials, each joined / glued / welded during or after the molding process. In such a case, the outsole 50 may include different portions having different hardness. For example, a front portion of the outsole 50 is made from a first polymer having a first Shore hardness and is welded to a rear portion of the outsole 50 made from a second material having a second Shore hardness different from the first Shore hardness. For example, the first portion is harder than the second portion.

[0044] In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-00 to 20Sh-0. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-0 to 20Sh-A. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-A to 20Sh-B. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-B to 20Sh-C. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-C to 20Sh-D. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-C to 30Sh-D. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-C to 40Sh-D. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-C to 50Sh-D. In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 20Sh-C to 60Sh-D.

[0045] In an embodiment, the outsole or a portion of the outsole has a Shore hardness of 40 to 55Sh A. In another embodiment, the outsole or a portion of the outsole has a Shore hardness of 50 to 70Sh A. In another embodiment, the outsole or a portion of the outsole has a Shore hardness of 65 to 90Sh A. In another embodiment, the outsole or a portion of the outsole has a Shore hardness of 55 to 60Sh A. In another embodiment, the outsole or a portion of the outsole has a Shore hardness of 65 to 70Sh A.

[0046] In another embodiment, the outsole 50 includes a layer 70 in contact with at least a portion of the at least one recess 60. In another embodiment, the outsole 50 includes a layer 70 in contact with at least a portion of the outer surface of the at least one recess 60. The layer 70 may be adapted to contact both the outsole 50 and one or more protrusions 20 and / or 30. The layer 70 may be made of a harder material, for example a polymer having a Shore hardness at least 5% harder than the Shore hardness of the outsole 50. The harder layer 70 may provide additional durability to the lower surface 55 or ground contact surface of the outsole 50. Thus, when a protrusion, such as, for example, the protrusions 20 and / or 30, is coupled or secured to the at least one recess 60, the softer material of the outsole 50 may not deform due to the force exerted by the protrusions 20 and / or 30, for example when the protrusions 20 and / or 30 bear the weight of a subject. In an embodiment, layer 70 may include a polymer or similar material characterized by a Shore hardness of 20Sh-A to 90Sh-D.

[0047] In an embodiment, the layer has a Shore hardness of 20Sh-0 to 20Sh-A. In an embodiment, the layer has a Shore hardness of 20Sh-A to 20Sh-B. In an embodiment, the layer has a Shore hardness of 20Sh-B to 20Sh-C. In an embodiment, the layer has a Shore hardness of 20Sh-C to 20Sh-D. In an embodiment, the layer has a Shore hardness of 20Sh-C to 30Sh-D. In an embodiment, the layer has a Shore hardness of 20Sh-C to 40Sh-D. In an embodiment, the layer has a Shore hardness of 20Sh-C to 50Sh-D. In an embodiment, the layer has a Shore hardness of 20Sh-C to 60Sh-D. In an embodiment, the layer has a Shore hardness of 20Sh-C to 80Sh-D.

[0048] In an embodiment, the layer has a Shore hardness of 40-55Sh A. In another embodiment, the layer has a Shore hardness of 50-70Sh A. In another embodiment, the layer has a Shore hardness of 65-90Sh A. In another embodiment, the layer has a Shore hardness of 55-60Sh A. In another embodiment, the layer has a Shore hardness of 65-70Sh A. In another embodiment, the layer has a Shore hardness of 50-90Sh A. In another embodiment, the layer has a Shore hardness of 40-80Sh A.

[0049] In another embodiment, the outsole 50 includes one recess 60, as shown in Figures 2A and 2B, or includes multiple recesses, for example two recesses, a front recess 62 and a rear recess 64, as shown in Figure 2C. The recess 60 shown in Figure 2B may include a front portion 61 adapted to match the base of the front lug 20 and a rear portion 63 adapted to match the base of the rear lug 30. In some embodiments, the front recess 62 shown in Figure 2C is adapted to match the front lug 20, and the rear recess 64 is adapted to match the rear lug 30. It should be understood by those skilled in the art that the specific shapes of the recess 60, the front recess 62, the rear recess 64, the front lug 20, and the rear lug 30 are provided by way of example only, and the invention as a whole is not limited to these specific designs.

[0050] In another embodiment, the outsole 50 may include one or more connectors 58 for connecting one or more lugs. The connectors 58 may be located at one or more locations within the recesses 60, the front recess 62, and / or the rear recess 64. For example, the connectors 58 may be press studs (e.g., snaps) as shown, or may be any element that may allow for removable / removable attachment of one or more lugs to at least one recess. The lugs 20 and 30 assembled and removably attached to the outsole 50 are shown in Figures 3A and 3B. Outsole Geometry

[0051] In another embodiment, the perimeter of at least one recess 60, 62, and / or 64 defines the base of one or more protrusions 20 and 30 adapted to be matched and / or surrounded therein, as shown in Figures 3A and 3B. The perimeter of each recess may roughly or tightly define the base of one or more protrusions. For example, a gap of 0.1-2 mm may be formed between the wall of at least one recess and the base of one or more protrusions. In yet another example, at least 25% of the base 24 and / or 34 (shown in Figure 5B) of one or more protrusions 20 and / or 30 is defined by at least one recess 60, 62, and / or 64. In another embodiment, at least 30% of the base is defined by at least one recess. In another embodiment, at least 40% of the base is defined by at least one recess. In another embodiment, at least 50% of the base is defined by at least one recess. In another embodiment, at least 60% of the base is defined by the at least one recess. In another embodiment, at least 70% of the base is defined by the at least one recess. In another embodiment, at least 80% of the base is defined by the at least one recess. In another embodiment, at least 90% of the base is defined by the at least one recess.

[0052] In another embodiment, the base of the protrusion occupies at least 50% of the area of ​​the single recess 60 such that a first perimeter of the base is adapted to fit a second perimeter of the single recess 60. For example, a gap of 0.1 to 1 mm may be formed between the wall of the recess 60 and the base of the single protrusion. In another embodiment, the base of the protrusion occupies at least 60% of the area of ​​the single recess 60. In another embodiment, the base of the protrusion occupies at least 70% of the area of ​​the single recess 60. In another embodiment, the base of the protrusion occupies at least 80% of the area of ​​the single recess 60. In another embodiment, the base of the protrusion occupies at least 90% of the area of ​​the single recess 60. In another embodiment, the base of the protrusion occupies at least 95% of the area of ​​the single recess 60.

[0053] In another embodiment, at least one recess 60, 62, and / or 64 has an area covering 10% to 95% of the ground contact surface or outer surface 55 of the outsole 50, as shown in Figures 2A-2C. The area of ​​at least one recess 60, 62, and / or 64 may be measured at the bottom of each recess. Alternatively, the area of ​​at least one recess 60, 62, and / or 64 may be measured as the area of ​​the opening of at least one recess 60, 62, and / or 64 in the ground contact surface or outer surface 55. In another embodiment, at least one recess has an area covering 15% to 85% of the entire ground contact surface or outer surface. In another embodiment, at least one recess has an area covering 20% ​​to 80% of the entire ground contact surface or outer surface. In another embodiment, at least one recess has an area covering 30% to 95% of the entire ground contact surface or outer surface. In another embodiment, at least one recess has an area covering 40% to 95% of the entire ground contact surface or outer surface. In another embodiment, the at least one recess has an area covering 50% to 95% of the entire ground surface or outer surface.

[0054] In another embodiment, the bases 24 and 34 of the two protrusions 20 and 30 may occupy at least 40% of the area of ​​a single recess 60, as shown in FIG. 3A. In another embodiment, the bases of two or more protrusions may occupy at least 50% of the area of ​​a single recess. In another embodiment, the bases of two or more protrusions may occupy at least 60% of the area of ​​a single recess. In another embodiment, the bases of two or more protrusions may occupy at least 70% of the area of ​​a single recess. In another embodiment, the bases of two or more protrusions may occupy at least 80% of the area of ​​a single recess. In another embodiment, the bases of two or more protrusions may occupy at least 90% of the area of ​​a single recess. In another embodiment, the bases of two or more protrusions may occupy at least 95% of the area of ​​a single recess.

[0055] Reference is now made to Figures 4A and 4B, which are bottom views of a kit and assembled footwear, respectively, including a single lug, according to some embodiments of the present invention. In another embodiment, the recess 60 of the outsole 50 is configured to receive a single lug 25. In another embodiment, the base of the lug 25 occupies at least 80% of the area of ​​the single recess 60 such that a first perimeter of the base is adapted to match a second perimeter of the single recess 60. In another embodiment, the base of the lug 25 occupies at least 90% of the area of ​​the single recess 60. In another embodiment, the base of the lug 25 occupies at least 95% of the area of ​​the single recess 60. In one embodiment, the lug 25 is a generally planar lug. Alternatively, the lug 25 is a non-planar lug, as described below.

[0056] In another embodiment, two or more recesses 62 and 64 in the outsole 50 are configured to receive two or more generally planar protrusions 25 .

[0057] Reference is now made to Figures 5A and 5B, which are front and inset views of an outsole 50 and the outsole receiving lugs according to some embodiments of the present invention.

[0058] In another embodiment, at least one recess 60, 62, and / or 64 may have a depth D1 and / or D2 of 10% to 95% of the maximum thickness T of the outsole 50. The depth may vary from recess to recess, for example, as shown, the depth D1 of the front portion 61 or front recess 62 is less than the depth D2 of the rear portion 63 or rear recess 64. The maximum thickness T of the outsole 50 may be measured from a ground contact point 56 at a ground contact surface 55 to a top point 57 at a surface of the outsole 50 adapted to be attached to an insole. In another embodiment, at least one recess may have a depth D1 and / or D2 of 15% to 95% of the maximum thickness T of the outsole. In another embodiment, at least one recess may have a depth D1 and / or D2 of 20% to 90% of the maximum thickness T of the outsole. In another embodiment, at least one recess may have a depth D1 and / or D2 of 10% to 90% of the maximum thickness T of the outsole. In another embodiment, the at least one recess may have a depth D1 and / or D2 of 10% to 80% of the maximum thickness T of the outsole. In another embodiment, the at least one recess may have a depth D1 and / or D2 of 10% to 70% of the maximum thickness T of the outsole. In another embodiment, the at least one recess may have a depth D1 and / or D2 of 10% to 60% of the maximum thickness T of the outsole.

[0059] In another embodiment, the recess is configured to securely fasten the protrusion. In another embodiment, a single recess is configured to securely fasten the protrusion. In another embodiment, a single recess is configured to securely fasten two protrusions. In another embodiment, two separate recesses are each configured to securely fasten a protrusion or a single protrusion. In another embodiment, the recess comprises a protrusion fastening means and / or a fastening means. In another embodiment, the protrusion comprises a recess fastening means and / or a fastening means. protrusion

[0060] In another embodiment, the projection has a base and an apex. In another embodiment, the base is the bottom of the projection and the apex is the top of the projection. In another embodiment, the apex or top portion occupies 5-60% of the projection volume. In another embodiment, the apex or top portion occupies 10-40% of the projection volume. In another embodiment, the apex or top portion occupies 5-30% of the projection volume. In another embodiment, the base or bottom portion occupies 30-95% of the projection volume. In another embodiment, the base or bottom portion occupies 40-95% of the projection volume. In another embodiment, the base or bottom portion occupies 60-90% of the projection volume. In another embodiment, the base or bottom portion occupies 70-95% of the projection volume.

[0061] In another embodiment, the projection has a harder lower portion (connectable to the recess) and a softer upper portion including the apex. In some embodiments, the hard lower portion is at least 10% harder than the soft lower portion. In some embodiments, the hard lower portion is at least 20% harder than the soft lower portion. In some embodiments, the hard lower portion is at least 30% harder than the soft lower portion. In some embodiments, the hard lower portion is at least 40% harder than the soft lower portion. In some embodiments, the hard lower portion is at least 50% harder than the soft lower portion.

[0062] In another embodiment, the upper soft portion occupies 30 to 90% of the protrusion volume. In another embodiment, the upper soft portion occupies 40 to 90% of the protrusion volume. In another embodiment, the upper soft portion occupies 30 to 80% of the protrusion volume. In another embodiment, the upper soft portion occupies 50 to 90% of the protrusion volume. In another embodiment, the upper soft portion occupies 40 to 70% of the protrusion volume. In another embodiment, the upper soft portion occupies 60 to 90% of the protrusion volume.

[0063] In another embodiment, the lower hard portion occupies 10 to 70% of the protrusion volume. In another embodiment, the lower hard portion occupies 20 to 60% of the protrusion volume. In another embodiment, the lower hard portion occupies 10 to 60% of the protrusion volume. In another embodiment, the lower hard portion occupies 20 to 70% of the protrusion volume. In another embodiment, the lower hard portion occupies 10 to 50% of the protrusion volume. In another embodiment, the lower hard portion occupies 10 to 50% of the protrusion volume. In another embodiment, the lower hard portion occupies 10 to 40% of the protrusion volume. In another embodiment, the lower hard portion occupies 30 to 70% of the protrusion volume.

[0064] In another embodiment, assembled footwear 100 or kit 200 includes one or more (e.g., two) lugs, such as, for example, lugs 20 and 30. In another embodiment, at least one lug 20 and / or 30 includes ground-contacting apex 22 and / or apex 32 and base 24 and / or base 34, respectively, as shown in FIG. 5B. In another embodiment, the lug is at least 10% higher at apex 22 and / or apex 34 than the maximum depth of at least one recess 60, 62, and / or 64. For example, height H2 of the lug at apex 32 may be at least 10% higher than depth D2 of recess 60. Height H1 or H2 is measured, for example, from base 34 to apex 32. In another embodiment, the lug is at least 15% higher at its apex than the maximum depth of at least one recess. In another embodiment, the lug is at least 20% higher at its apex than the maximum depth of at least one recess. In another embodiment, the protrusion is at least 30% taller at its apex than the maximum depth of the at least one recess. In another embodiment, the protrusion is at least 40% taller at its apex than the maximum depth of the at least one recess. In another embodiment, the protrusion is at least 50% taller at its apex than the maximum depth of the at least one recess. In another embodiment, the protrusion is at least 60% taller at its apex than the maximum depth of the at least one recess. In another embodiment, the protrusion is at least 70% taller at its apex than the maximum depth of the at least one recess. In another embodiment, the protrusion is at least 80% taller at its apex than the maximum depth of the at least one recess. In another embodiment, the protrusion is at least 95% taller at its apex than the maximum depth of the at least one recess. In another embodiment, the protrusion is at least twice as taller at its apex than the maximum depth of the at least one recess.

[0065] In another embodiment, as shown in Figures 3A, 3B, and 4B, the ground contact surfaces (e.g., surfaces of apexes 22 and 32) of one or more of the protrusions 20 and 30 extend outwardly from the outsole or extend outwardly from at least one of the recesses 60, 62, and / or 64 when the one or more of the protrusions 20 and 30 are positioned and / or secured in the at least one of the recesses 60, 62, and / or 64.

[0066] 4A and 4B, which show a single generally flat protrusion 25. In one embodiment, the additional protrusion is a generally flat protrusion 25. In one embodiment, the kit includes at least one recess 60 or a set of two generally flat protrusions that are assembled into two different recesses 62 and 64. The one or more generally flat protrusions include a flat ground surface. Such a flat ground surface may be patterned to improve ground surface engagement. In another embodiment, the one or more protrusions are configured with one or more flexible areas to improve ground surface engagement and facilitate use of the footwear. In another embodiment, the kit includes a pair of curved or spherical protrusions and a pair of flat protrusions.

[0067] In another embodiment, the maximum thickness of the at least one substantially flat protrusion is the same as or higher than the maximum depth of the at least one recess. In another embodiment, the maximum thickness of the at least one substantially flat protrusion 25 is at least 5% higher than the maximum depth of the at least one recess. In another embodiment, the maximum thickness of the at least one substantially flat protrusion 25 is at least 10% higher than the maximum depth of the at least one recess. In another embodiment, the maximum thickness of the at least one substantially flat protrusion 25 is at least 15% higher than the maximum depth of the at least one recess. In another embodiment, the maximum thickness of the at least one substantially flat protrusion 25 is at least 20% higher than the maximum depth of the at least one recess. In another embodiment, the maximum thickness of the at least one substantially flat protrusion 25 is at least 30% higher than the maximum depth of the at least one recess. In another embodiment, the maximum thickness of the at least one substantially flat protrusion 25 is at least 40% higher than the maximum depth of the at least one recess.

[0068] In another embodiment, in the assembled footwear, the portion of the lug occupies at least 80% of the recess area or volume. In another embodiment, in the assembled footwear, the portion of the lug occupies at least 85% of the recess area or volume. In another embodiment, in the assembled footwear, the portion of the lug occupies at least 90% of the recess area or volume. In another embodiment, in the assembled footwear, the portion of the lug occupies at least 95% of the recess area or volume. In another embodiment, in the assembled footwear, the portion of the lug occupies at least 97% of the recess area or volume.

[0069] In another embodiment, in the assembled footwear, the lower or base of the lug comprises an outer surface, the outer surface abutting the recess and occupying at least 95% of the area or volume of the recess.

[0070] In another embodiment, in the assembled footwear, the lower or base of the lug accounts for at least 95% of the recess area or volume. In another embodiment, in the assembled footwear, 2-50%, 2-20%, 5-40%, 20-40%, 5-15%, or 10-30% of the lug volume accounts for at least 80%, 90%, 95%, or 97% of the recess area or volume.

[0071] In another embodiment, at least one of the protrusions 20 and / or 30 is a spherical protrusion. In another embodiment, the protrusion is symmetric. In another embodiment, the protrusion is asymmetric. In another embodiment, the protrusion comprises a polygon, a decagon, a diagonal, a dodecagon, a nonagon, a unilateral, an eleventh, a heptagon, a hexagon, a hexagon, an icosagon, an octagon, a pentagon, a triangle, a Penrose tile, a trapezoid, an isosceles triangle, a trapezoid, an eleventh, a quadrilateral, a rhombus, a rhomboid, a rectangle, a square, a rhombus, a trapezoid, a polydraft, an arbelos, a circle, a disk, a crescent, a hemisphere, an ellipse, a bow, an oval, a sphere, a star, or a triangle. In another embodiment, at least one of the protrusions 20 and / or 30 has an amorphous curvature.

[0072] In another embodiment, each protrusion 20 or 30 has a curved outer contour 26 or 36. In another embodiment, each protrusion 20 or 30 has a different curved outer contour, as shown. In another embodiment, each protrusion 20 or 30 has a convex surface.

[0073] In another embodiment, the outer contour 26 and / or 36 of one or more of the projections 20 and / or 30 and the outer contour 57 of the outsole 50 form a continuous curvature, as shown in FIG. 5B. In another embodiment, the curvature is continuous across any cross-section or in one or more particular cross-sections of the outsole and one or more projections. For example, the curvature may be continuous across the longitudinal cross-section (as shown) and / or across the lateral cross-section.

[0074] In another embodiment, the protrusions, such as protrusions 20 and / or 30, comprise a dome shape. In another embodiment, the protrusions described herein comprise a dome shape further comprising a plurality of different convex surfaces. In another embodiment, each protrusion 20 or 30 comprises a different convex surface. In another embodiment, each protrusion 20 or 30 comprises a different set of convex surfaces. Each possibility represents a separate embodiment of the present invention.

[0075] In another embodiment, the contour 26 and / or 36 may have a conical section shape, i.e., a circular, elliptical, parabolic, or hyperbolic shape. The various cross sections of the contour 26 or 36 of the projection 20 or 30 may be the same or different shapes. In another embodiment, the shape of the projection is defined by equal arcs. In another embodiment, the shape of the projection is defined by various arcs of different radii that are tangent to one another. In another embodiment, the shape of the projection is symmetrical. In another embodiment, the shape of the projection is asymmetrical. In another embodiment, the projection is a spherical projection. Each possibility represents a separate embodiment of the present invention.

[0076] In another embodiment, the present invention provides that when one or more prongs are placed on the ground, the assembled footwear, e.g., assembled footwear 100, supports the subject's foot only by one or more prongs. In another embodiment, the present invention provides that when two prongs are placed on the ground, the device, e.g., assembled footwear 100, supports the subject's foot during stance only by two prongs 20 and 30. In another embodiment, the present invention provides that when standing, only two ground contact surfaces (e.g., tops or ground-facing surfaces) of the prongs contact the ground. In another embodiment, the present invention provides that when standing, only the ground contact surface of each prong contacts the ground. Each possibility represents a separate embodiment of the present invention.

[0077] In another embodiment, the ground-contacting portions of assembled footwear 100 are only the lugs. In another embodiment, the only parts of assembled footwear that come into direct contact with the ground during all gait phases, including the stance phase, are the lugs. In another embodiment, the only parts of assembled footwear that come into direct contact with the ground during all gait phases, including the stance phase, are the lugs 20 and 30. Each possibility represents a separate embodiment of the present invention.

[0078] In another embodiment, the ground contact portion of the assembled footwear comprises lugs 20, 25, and 30. In another embodiment, the ground contact portion of the assembled footwear comprises ground contact surface 55 of outsole 50. In another embodiment, the lugs are the only parts of the footwear kit that come into contact with the ground during all gait phases, including the stance phase.

[0079] In another embodiment, the projections described herein are mountable in recesses in the outsole. In another embodiment, the projections described herein are fixedly mounted in recesses in the outsole. In another embodiment, the projections described herein are replaceable.

[0080] In another embodiment, the lugs have a Shore hardness of 30-90Sh A so that they are relatively stiff and do not compress under the weight of a subject wearing the footwear (20-150 kg). In another embodiment, the lugs have a Shore hardness of 40-55Sh A. In another embodiment, the lugs have a Shore hardness of 50-70Sh A. In another embodiment, the lugs have a Shore hardness of 65-90Sh A. In another embodiment, the lugs have a Shore hardness of 55-60Sh A. In another embodiment, the lugs have a Shore hardness of 65-70Sh A. In another embodiment, the front and rear lugs have the same Shore hardness. In another embodiment, the front and rear lugs have different Shore hardnesses. Each possibility represents a separate embodiment of the present invention.

[0081] In another embodiment, the protrusions are relatively stiff and non-compressible, so that they maintain their contour under the subject's body weight (20-150 kg). In another embodiment, the non-compressible protrusions maintain their contour under a weight of 0-150 kg. In another embodiment, the non-compressible protrusions maintain their contour, prominence, height, or any combination thereof under a weight of 0-150 kg.

[0082] In another embodiment, the protrusions are soft protrusions with a Shore hardness of 40 to 55Sh A. In another embodiment, the protrusions are medium hardness protrusions with a Shore hardness of 50 to 70Sh A. In another embodiment, the protrusions are hard protrusions with a Shore hardness of 65 to 90Sh A.

[0083] In another embodiment, the protrusion is 1 to 60 mm 3 (according to DIN 53516). In another embodiment, the protrusion comprises a rubber cup. In another embodiment, the protrusion comprises a natural rubber compound. In another embodiment, the protrusion comprises a synthetic rubber compound, such as, for example, TPU or TPR. In another embodiment, the protrusion comprises a cast polyurethane. In another embodiment, the protrusion comprises ethylene vinyl acetate. In another embodiment, the protrusion comprises silicone. In another embodiment, the protrusion comprises a plastic material, such as, for example, PA6 (nylon), PA6 / 6 (nylon) + glass fiber, ABS, polypropylene, POM (polyoxymethylene). In another embodiment, the protrusion comprises a metal, such as, for example, aluminum, steel, stainless steel, brass, metal alloys. In another embodiment, the protrusion comprises a composite material, such as, for example, glass fiber, carbon fiber, Kevlar, or any combination thereof. Each possibility represents a separate embodiment of the present invention.

[0084] In another embodiment, the geometry and / or structure of the protrusions 20, 30, and / or 25 are adapted to be responsive to the application of pressure. When the subject is standing, walking, and / or running, the shape and / or structure of the protrusions 20, 30, and / or 25 change. In such cases, the position of the apex of the protrusions 20 and 30 changes depending on the position of the leg.

[0085] Thus, protrusions 20, 30, and / or 25 comprise one or more deformable materials. A deformable material is defined as a material that allows deformation of at least 10% of its original shape upon application of external pressure during use (e.g., at room temperature). For example, the protrusions may comprise a flexible shell filled with a liquid (e.g., water, oil), a granular material (e.g., sand), a gel, or the like. Protrusion Selection

[0086] In one embodiment, at least one set of one or more prongs is provided in kit 200. Upon receiving a selected set, a subject may easily couple one or more prongs 20, 30, and / or 25 to an outsole, for example using connector 58, to form assembled footwear 100, and wear assembled footwear 100.

[0087] In another embodiment, each set provided in the kit may be selected to manipulate at least one gait parameter and / or treat a pathology. Additionally or alternatively, at least one set of protrusions includes one or more substantially flat protrusions. In some embodiments, the kit 200 may include one set of one or more substantially flat protrusions and at least one other set including one or more non-flat functional protrusions. In some embodiments, the gait parameters are selected from foot alignment, knee alignment, speed, swing and stance phases, double support time, ground reaction forces, impulse, propulsion during habitual gait, knee alignment, center of pressure, symmetry, gait speed, step time, step length, stride length, step width, foot angle, boundary between walking and running, and the like.

[0088] As should be understood by those skilled in the art, the non-planar protrusions are functional protrusions that are selected according to the disclosure below.

[0089] In another embodiment, the set may be selected to include protrusions having a prominence, height, structure, and / or apex adapted to manipulate at least one gait parameter, treat or reduce leg or back pain, or ameliorate a leg pathology or pelvic disorder, such as, but not limited to, urinary incontinence. In some embodiments, the location, surface area, and / or prominence of the apex is adapted to manipulate at least one gait parameter, treat or reduce leg or back pain, or ameliorate a leg pathology or pelvic disorder, such as, but not limited to, urinary incontinence. In some embodiments, the location of the apex is a location along the outsole. In some embodiments, the location of the apex is a location relative to the base of the protrusion or the center of the outer surface of the base.

[0090] In some embodiments, the one or more protrusions may be selected according to the required manipulation of at least one gait parameter or improvement of a leg pathology. In another embodiment, the height of the protrusion at the apex (e.g., height H) is adapted to manipulate at least one gait parameter, treat or reduce leg or back pain, or improve a leg pathology or pelvic disorder, such as, but not limited to, urinary incontinence.

[0091] In some embodiments, a set of lugs may be manufactured for a subject and pathology combination such that an individual may select footwear 100 and / or kit 200 based on at least two characteristics. For example, an individual may order footwear 100 of kit 200 based on their age, sex, gait parameters, and pathology / condition. A list of pathologies and conditions that can be treated by footwear 100 or kit 200 is provided below.

[0092] In another embodiment, two or more sets of lugs are provided in the kit 200 or assembled footwear 100. In one embodiment, each lug in the kit 200 or assembled footwear differs with respect to at least the location of the apex, the height of the lug at the apex, the prominence, the Shore hardness, or any combination thereof. In one embodiment, a first set of lugs is selected to manipulate a first gait parameter and a second set of lugs is selected to manipulate a second gait parameter. In one embodiment, a first set of lugs is selected for initial treatment of a lesion or pain and a second set is selected for further treatment of a lesion or pain.

[0093] In another embodiment, the set includes two lugs on each shoe of footwear 100. In another embodiment, the set includes four lugs on both shoes (two shoes) of footwear 100. In another embodiment, each lug or set is specifically designed for a subject or gait condition. In another embodiment, each set is designed and manufactured for a group of subjects with similar pathologies or similar gait parameters. In another embodiment, each set is designed and manufactured for a group of subjects with at least one similar gait parameter. Each possibility represents a separate embodiment of the present invention.

[0094] In another embodiment, the selection of the protrusions and / or sets of protrusions 20 and 30 are directed to the treatment and relief of pain associated with the following diseases and / or conditions: medial compartment knee OA, medial meniscus tear / injury, genu varum, patellofemoral pain syndrome, patellofemoral problems (misalignment), lateral collateral ligament (injury / rupture), bone contusion MTP / MFC (AVN), hip OA, hip labrum tear (TCM), trochanteric bursitis, anserine pes, ankle instability (supination + ext rut), Achilles tendonitis, metatarsalgia, or combinations thereof.

[0095] In another embodiment, the selection of the projections and / or projection sets is directed to the treatment and relief of pain associated with the following diseases and / or conditions: spinal disorders, spinal lesions, spinal injuries, and / or spinal related pathologies. In another embodiment, the selection of the projection sets is directed to the treatment and relief of pain in subjects suffering from neurological conditions. Protrusion Design

[0096] In another embodiment, the protrusions are designed and manufactured, for example using three-dimensional (3D) printing or any other CAD-CAM manufacturing method, to treat various conditions, with each protrusion having parameters selected from an apex location, a protrusion height at the apex, a protrusion degree, a Shore hardness, or any combination thereof.

[0097] In some embodiments, for each protrusion, the location of at least the apex is determined based on at least one gait and / or balance parameter of the subject measured for the group of subjects. In some embodiments, measurements of a selection of gait parameters may be obtained from a plurality of subjects, such as a group, all of whom have at least two common characteristics selected from, for example, age, sex, height, weight, foot size, gait behavior, pathology, etc. In some embodiments, subjects with common gait behavior are subjects with at least two similar gait parameters. In some embodiments, a group of subjects is defined as subjects with 1, 2, 3, 4, 5, 5, 6, 7, 8, 9, 10, or any range of numbers therebetween common gait parameter(s) (common gait defect(s)). In some embodiments, a common gait behavior is defined as a common defect in 1, 2, 3, 4, 5, 5, 6, 7, 8, 9, 10, or any range of numbers therebetween common gait parameter(s).

[0098] As used herein, subject balance parameters include parameters related to the subject's standing / balance position and posture. A balanced position is a position in which the device provides reduced and / or minimal inversion and / or reduced and / or minimal eversion to the subject's foot during stance phase. In some embodiments, a balanced position adjusts the amount of tension or resistance to the movement of the muscles involved in walking. A balanced position provides reduced muscle tone, greater passive ankle deviation, improved walking ability, or any combination thereof.

[0099] The balance parameters are those for which the footwear exerts minimal valgus, varus, dorsal or plantar torque on the ankle of the experimental subject, such as weight distribution between the legs, the subject's body inclination, spinal structure when standing upright, etc.

[0100] In some embodiments, subjects are grouped according to age group (e.g., 20-30 years, 30-45 years, 45-50 years, 50-55 years, 55-60 years, etc.) and gender. In some embodiments, subjects are grouped according to age group and pathology, such as, for example, subjects aged 50-55 years with lower extremity pathology. In yet another example, a subject group may include women aged 60-70 years with pelvic disorders, such as, but not limited to, urinary incontinence. In some embodiments, subjects are grouped according to age, common gait behavior / common gait defect(s), pathology (such as, but not limited to, lower extremity pathology, spinal pathology, and urinary incontinence), or any combination thereof.

[0101] In some embodiments, subjects are grouped according to age group and gait behavior / common defect(s). For example, subjects who have not been diagnosed with a specific limb or back pathology are grouped according to subjects of the same age group having substantially the same (e.g., less than 10% difference) at least two gait parameters, such as substantially the same foot alignment, knee alignment, walking speed, step time, step length, stride length, step width, foot angle, walking-running boundary, speed, swing and stance phases, double support time, ground reaction forces, impulses, propulsive forces during habitual gait, etc.

[0102] In some embodiments, the gait parameter measurements obtained from each subject group are used to design a projection set suitable for the groups provided herein (any subjects with similar characteristics). In some embodiments, the subject or expert can select the projection set based on group characteristics that match the characteristics of the subjects, such as, for example, walking behavior / common gait defect(s), pathology (such as, but not limited to, lower extremity pathology, spinal pathology, and urinary incontinence), or any combination thereof.

[0103] In some embodiments, in addition to or as an alternative to the apex position, the curvature of each protrusion and / or the contour of the base of the protrusion may be determined based on at least one gait and / or balance parameter of a subject measured for a group of subjects.

[0104] In some embodiments, the gait parameter(s) and / or balance parameter measurements from each subject group are used to select multiple geometric parameters that affect the location of the apex, the curvature of each lug, and the profile of each lug, in some embodiments, the parameters are selected from the location of the apex relative to the outsole topography and profile (e.g., medial and lateral lugs), the height of the apex, the prominence(s) of the curvature in each direction, etc.

[0105] Reference is now made to Figures 6A, 6B, 6C, and 6D, which are bottom, front, side, and back views, respectively, of an outsole receiving lugs designed based on gait parameters, according to some embodiments of the present invention. In some embodiments, for each of the lugs 20 or 30, the location of at least the corresponding apex 22 or 32 is determined based on at least one gait and / or balance parameter of the subjects measured for the subject group. For example, the area of ​​each lug 20 or 30 may be divided by grids 40 and 45 comprising lateral and longitudinal midlines. For example, the area of ​​the lug 20 may be divided by grid 40 and include lateral midline 41 and longitudinal midline 42. Similarly, the area of ​​the lug 30 may be divided by grid 45 and include lateral midline 43 and longitudinal midline 44.

[0106] In the non-limiting example shown in Figures 6A, 6B, 6C, and 6D, the location of apices 22 and 32 was determined based on gait parameters received from a group of 35-45 year old women with urinary incontinence. After receiving the measurements, the controller may determine, for example, based on previously collected data, where the optimal location of apices 22 and 32 is to treat urinary incontinence for this group. In this non-limiting example, apices 22 is 0.5 steps to the left of vertical midline 42 on horizontal midline 41, and apices 32 is 0.5 steps to the right of vertical midline 44 on horizontal midline 43.

[0107] In some embodiments, the contour of protrusion 20 or 30 may also be determined based on gait parameters measured from a group of subjects. In the non-limiting example of FIG. 6A, contour 46 of protrusion 20 and contour 47 of protrusion 30 were determined based on gait parameters received from a group of 35-45 year old women with urinary incontinence and designed to treat this particular group.

[0108] In some embodiments, the curvature of the projections 20 or 30 may also be determined based on gait parameters measured from a group of subjects. In some embodiments, each projection 20 or 30 may be divided by a corresponding vertical midline 81 and 82. The vertical midline may divide the curved surfaces 26 and 36 into different convex surfaces. In the non-limiting example of Figures 6B, 6C, and 6D, the curved surface 26 is divided into four different convex surfaces 26a, 26b, 26c, and 26d, and the curved surface 36 is divided into four different convex surfaces 36a, 36b, 36c, and 36d. In some embodiments, each of the convex surfaces may be determined based on gait parameters measured from a group of subjects. In the non-limiting example of Figures 6B, 6C, and 6D, convex surfaces 26a, 26b, 26c, and 26d and convex surfaces 36a, 36b, 36c, and 36d are determined based on gait parameters received from a group of women ages 35-45 with urinary incontinence and are designed to treat this particular group.

[0109] In some embodiments, the hardness of each protrusion 20 or 30 may also be determined based on gait parameters received from a group of subjects. A similar methodology may be applied to the required hardness. For example, a relatively hard (e.g., non-compressible) material may be selected having a Shore hardness of 30-90Sh A. In a particular example, a Shore hardness of 60Sh A may be selected for treating pelvic disorders, such as, but not limited to, urinary incontinence, in women aged 40-45, and a Shore hardness of 70Sh A may be selected for protrusions intended for the prevention of back pain in men aged 40-60.

[0110] In some embodiments, a training phase may be conducted in which gait parameter measurements from different subject groups are collected and a design of the protrusion may be proposed based on known geometric parameters of the protrusion. These geometric parameters have known effects on subjects and pathologies and may be received from experts (e.g., doctors, physical therapists, trainers, etc.) who treat individuals in the subject group. In some embodiments, the geometric parameters may include the location of the apex, the height of the apex, and various curvatures. For example, the controller may collect various apex locations for a particular group and determine what is the optimal location of the apex using any mathematical model, e.g., average location, most common location, etc. After designing an initial design, the initial design may be manufactured and the design may be tested on subjects in the group to receive feedback from the subjects and / or experts. Improvements may be made to the design, if necessary.

[0111] In another embodiment, the projection is designed and manufactured to treat a subject suffering from patellofemoral pain and hyperlaxity. The parameters of the anterior and posterior projections are selected to improve the balance and reduce pain for the subject. In another embodiment, the projection is designed and manufactured to treat a subject suffering from patellofemoral pain, early heel rise, and hyperlaxity. The parameters of the anterior and posterior projections are selected to improve the balance and reduce pain for the subject. Also, to reduce early heel rise, the height at the apex of the posterior projection is selected to be greater than the height at the apex of the anterior projection.

[0112] In another embodiment, the protrusion is designed and manufactured to treat a subject suffering from patellofemoral knee OA, with a relatively high knee ROM (range of motion) for his / her age, and pain relief and delayed heel rise when walking uphill. The parameters of the anterior and posterior protrusions are selected to improve the balance and reduce pain of the subject. Also, the height of the apex of the posterior protrusion is selected to be lower than the height of the apex of the anterior protrusion to adjust the heel rise during stance of the subject.

[0113] In another embodiment, the protrusions are designed and manufactured to treat a subject suffering from medial compartment knee OA, with sudden severe pain in the left knee, Avascular necrosis in the proximal medial tibial plateau of the left knee, 33% left leg support, and 37.5% right leg support. The parameters of the anterior and posterior protrusions are selected to improve the subject's balance and reduce pain. Also, the height of the top of the anterior and posterior protrusions of the left leg are selected to be higher than the height of the protrusions of the right leg.

[0114] In another embodiment, the lugs are designed and manufactured to treat subjects suffering from knee pain during heel strike. In such a case, the location of the apex of the posterior lugs is selected to have the posterior lugs lateral to the centerline. In another embodiment, the lugs are designed and manufactured to treat subjects suffering from knee pain during mid-stance / toe-off. In such a case, the location of the apex of the anterior lugs is selected to have the apex lateral to the centerline of the assembled footwear.

[0115] In another embodiment, the center line of the assembled footwear bisects the calcaneal support portion longitudinally and further extends in a straight line toward the phalangeal and metatarsal support portion. In another embodiment, the center line of the assembled footwear bisects the arch of the calcaneal support portion longitudinally and further extends in a straight line toward the phalangeal and metatarsal support portion. In another embodiment, the center line of the assembled footwear bisects the proximal arch of the calcaneal support portion longitudinally and further extends in a straight line toward the phalangeal and metatarsal support portion. In another embodiment, the center line of the assembled footwear bisects the calcaneal support portion longitudinally and further extends in a straight line toward the phalangeal and metatarsal support portion. Each possibility represents a separate embodiment of the present invention.

[0116] In another embodiment, the lugs are designed and manufactured to treat subjects suffering from pain in the pes anserine region during heel strike. In such a case, the location of the apex of the posterior lugs is selected to be centered on the centerline of the assembled footwear. In another embodiment, the lugs are designed and manufactured to treat subjects suffering from pain in the pes anserine region during mid-stance / toe-off. In such a case, the location of the apex of the anterior lugs is selected to be centered on the centerline of the assembled footwear.

[0117] In another embodiment, the lug is designed and manufactured to treat subjects suffering from medial patella pain during heel strike. In such a case, the location of the posterior lug is selected to be anterior (front) toward the latitude of the assembled footwear.

[0118] In another embodiment, the lug is designed and manufactured to treat subjects suffering from mid-stance / toe-off pain on the medial aspect of the patella, in such a case, the location of the apex of the anterior lug is selected to be posterior toward the anterior end of the calcaneus of the assembled footwear.

[0119] In another embodiment, the projection is designed and manufactured to treat a subject suffering from lateral patella pain during heel strike. In such a case, the location of the posterior projection is selected to be anterior (front). In another embodiment, the projection is designed and manufactured to treat a subject suffering from lateral patella pain during mid-stance / toe-off. In such a case, the location of the apex of the anterior projection is selected to be posterior to the midline.

[0120] In another embodiment, the projection is designed and manufactured to treat a subject suffering from suprapatellar pain during heel strike. In such a case, the location of the apex of the posterior projection is selected to be anterior to at least one recess. In another embodiment, the projection is designed and manufactured to treat a subject suffering from suprapatellar pain during midstance / toe off. In such a case, the location of the apex of the anterior projection is selected to be posterior to the centerline.

[0121] In another embodiment, the assembled footwear 100 provides pain relief at the medial femoral condyle. In another embodiment, the assembled footwear 100 provides pain relief at heel strike. In another embodiment, the assembled footwear 100 provides pain relief at mid-stance / toe off. In another embodiment, the assembled footwear 100 provides pain relief at the medial femoral condyle. In another embodiment, the assembled footwear 100 provides pain relief at the proximal medial tibia. In another embodiment, the assembled footwear 100 provides pain relief at the proximal lateral tibia. In another embodiment, the assembled footwear 100 provides pain relief at the insertion of the medial head of the gastrocnemius. In another embodiment, the assembled footwear 100 provides pain relief at the insertion of the Achilles tendon. In another embodiment, the assembled footwear 100 provides pain relief at the insertion of the medial hamstring. In another embodiment, the assembled footwear 100 relieves pain at the insertion site of the lateral hamstring. In another embodiment, the assembled footwear 100 relieves pain at the insertion site of the lateral head of the gastrocnemius. Each possibility represents a separate embodiment of the present invention.

[0122] In another embodiment, lower extremity musculoskeletal pain or disorders, such as those described herein, result in a gait disorder that can be treated according to the methods described herein. Common symptoms

[0123] In some embodiments, the use of the assembled footwear disclosed herein is directed to a method of controlling or manipulating at least one gait parameter. In some embodiments, the gait parameter is selected from foot alignment, knee alignment, speed, step length, swing and stance phases, double support time, ground reaction force, impulse, propulsion during habitual gait, knee alignment, center of pressure, symmetry, walking speed, step time, step length, stride length, step width, foot angle, boundary between walking and running, etc. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate step length, which is the length measured parallel to the body's line of progression from the rear contact point (heel) of the previous step to the rear contact point (heel) of the current opposite step. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate stride length, which is the distance measured parallel to the line of progression between the rear heel points of two successive footprints of the foot in question. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate a step width, which is the distance measured between a left foot line of progression and a right foot line of progression. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate a foot angle, which is the angle between the line of progression and a foot axis. The foot angle is zero when the foot axis is parallel to the line of progression. The foot angle is positive when the foot axis points outward relative to the line of progression. The foot angle is negative when the foot axis points inward relative to the line of progression. Each possibility represents a separate embodiment of the present invention.

[0124] In some embodiments, one or more lugs of the assembled footwear disclosed herein are configured / configured for use in a balanced position, which is a position in which the assembled footwear provides reduced and / or minimal inversion or reduced and / or minimal eversion to the subject's foot during stance phase.

[0125] In some embodiments, one or more lugs of the assembled footwear disclosed herein are designed to manipulate the balance of each foot of the subject and / or the overall balance of the subject. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate the balance of both feet during stance. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate the balance of both feet during walking. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate the balance of both feet during running. In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to manipulate the balance of each foot separately. Degenerative joint disease

[0126] In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to treat a lower limb joint condition comprising a lower limb joint disease, a degenerative lower limb joint disease, a degenerative lower limb disease, a lower limb musculoskeletal pathology, a lower limb musculoskeletal trauma, a lower limb musculoskeletal disease, a lower limb osteoarthritis, or any combination thereof. In another embodiment, the lower limb joint condition is associated with lower limb musculoskeletal pain.

[0127] In another embodiment, the lower limb joint pathology is a degenerative joint disease of the hip, ankle, foot, or knee. In another embodiment, the lower limb joint pathology comprises a degenerative joint disease, such as, for example, osteoarthritis. In another embodiment, the osteoarthritis is idiopathic osteoarthritis. In another embodiment, the degenerative joint disease is lower limb osteoarthritis, in another embodiment, the degenerative joint disease is knee osteoarthritis. In another embodiment, the hip, ankle, foot, or knee osteoarthritis is primary osteoarthritis. Each possibility represents a separate embodiment of the present invention.

[0128] In another embodiment, the degenerative joint disease is osteoarthritis of the ankle. In another embodiment, the degenerative joint disease is osteoarthritis of the hip. In another embodiment, the osteoarthritis is secondary osteoarthritis. In another embodiment, the knee osteoarthritis is secondary osteoarthritis of the knee. In another embodiment, the classification as primary or secondary depends on whether there is an identifiable underlying cause. Each possibility represents a separate embodiment of the present invention.

[0129] In another embodiment, the lower limb joint pathology is patellar pressure. In another embodiment, the lower limb joint pathology is joint line tenderness. In another embodiment, the lower limb joint pathology is joint line effusion. In another embodiment, the lower limb joint pathology is patellar tendonitis. In another embodiment, the lower limb joint pathology is infrapatellar tendonitis. In another embodiment, the lower limb joint pathology is pain and / or tenderness of any patella or anterior patellar anatomical structure. Each possibility represents a separate embodiment of the present invention. In another embodiment, the tendonitis is tendon degeneration. In another embodiment, the tendonitis is tendonitis. In another embodiment, the tendonitis is tendon originating pain due to degenerative changes in the tendon.

[0130] In another embodiment, the lower limb joint pathology is a degenerative lower limb joint pathology. In another embodiment, the lower limb joint pathology is medial / lateral / patellofemoral osteoarthritis (OA) or any combination thereof (primary or secondary). In another embodiment, the lower limb joint pathology is anserine bursitis. In another embodiment, the lower limb joint pathology is characterized by anterior knee pain and / or patellofemoral pain. In another embodiment, the lower limb joint pathology is a meniscus tear (both degenerative and traumatic). In another embodiment, the lower limb joint pathology is a ligament tear / partial tear / strain / post-reconstruction (ACL, PCL, MCL, LCL), or any combination thereof. In another embodiment, the lower limb joint pathology includes pre / post total, hemi, or surface replacement arthroplasty and pre / post use of the methods described herein. In another embodiment, the lower limb joint pathology is a tibial plateau fracture. In another embodiment, the lower limb joint pathology is osteonecrosis (both in the tibia and femur). In another embodiment, the lower extremity joint pathology is patellar tendonitis. In another embodiment, the lower extremity joint pathology is Osgood-Schlatter's disease. In another embodiment, the lower extremity joint pathology comprises post-lower extremity surgery. Each possibility represents a separate embodiment of the present invention.

[0131] In another embodiment, the lower limb joint pathology is hip replacement. In another embodiment, the lower limb joint pathology is hip resurfacing. In another embodiment, the lower limb joint pathology is prepatellar bursitis. In another embodiment, the lower limb joint pathology is trochanteric bursitis. In another embodiment, the lower limb joint pathology comprises necrosis within a lower limb joint. In another embodiment, the lower limb joint pathology comprises hip fracture. In another embodiment, the lower limb joint pathology comprises developmental hip dysplasia. In another embodiment, the lower limb joint pathology comprises hip tendinitis / tendonitis. In another embodiment, the lower limb joint pathology comprises hip impingement. Each possibility represents a separate embodiment of the present invention.

[0132] In another embodiment, the lower limb joint pathology comprises osteochondrosis dissecans of the foot or ankle. In another embodiment, the lower limb joint pathology comprises acute or chronic instability of the foot or ankle. In another embodiment, the lower limb joint pathology comprises ligament sprains, tears, and / or repairs in the foot or ankle joint. In another embodiment, the lower limb joint pathology comprises a fracture of the foot or ankle. In another embodiment, the lower limb joint pathology comprises plantar fasciitis. In another embodiment, the lower limb joint pathology comprises posterior tibial insufficiency and / or dysfunction. In another embodiment, the lower limb joint pathology comprises a pronated foot. In another embodiment, the lower limb joint pathology comprises a supinated foot. In another embodiment, the lower limb joint pathology comprises a flat foot or a cavus foot. Each possibility represents a separate embodiment of the present invention.

[0133] In another embodiment, the lower limb joint pathology comprises iliotibial band (ITB) syndrome. In another embodiment, the lower limb joint pathology comprises hyperlaxity or hypermobility. In another embodiment, the lower limb joint pathology comprises muscle atrophy. In another embodiment, the lower limb joint pathology comprises a tumor in the lower limb. In another embodiment, the lower limb joint pathology comprises a tumor affecting a joint of the lower limb. Each possibility represents a separate embodiment of the present invention.

[0134] In another embodiment, a treatment or procedure according to the present invention comprises reducing, mitigating, reducing, inhibiting, improving, halting, and / or ameliorating pain, stiffness, swelling, inflammation, cartilage degeneration, osteophytes, joint space narrowing, effusion, muscle atrophy, poor neuromuscular control, poor proprioceptive bracing, pathological moments, gait disturbances, lameness, compensatory gait, painful gait, gait asymmetry, muscular guarding, ligament laxity, joint capsule laxity, ligament stretch, joint capsule stretch, decreased step length, decreased single support, increased single support, decreased gait speed, or any combination thereof. In another embodiment, a treatment or procedure according to the present invention comprises reducing, mitigating, reducing, inhibiting, improving, halting, and / or ameliorating bone marrow edema, lesions, subchondral bone changes, cartilage softening, cartilage fibrosis and thinning, bone dentinization, or any combination thereof.

[0135] In another embodiment, the treatment or procedure comprises performing various maneuvers in a proprioceptive and / or kinesthetic exercise regimen for the feet, legs, upper legs, lower back, and even the upper body and other body parts and organs. In another embodiment, the treatment or procedure comprises performing various walking and / or ambulatory exercise regimens for the feet, upper legs, lower back, and even the upper body and other body parts and organs. Each possibility represents a separate embodiment of the present invention.

[0136] In another embodiment, the subject suffers from pain resulting from a lower extremity joint pathology. In another embodiment, the subject suffers from pain, joint pain, tenderness, stiffness, locking, effusion, or any combination thereof. In another embodiment, the subject suffers from cartilage loss. In another embodiment, the subject suffers from reduced movement secondary to pain. In another embodiment, the subject suffers from localized muscle atrophy. In another embodiment, the subject suffers from ligament laxity. In another embodiment, the subject suffers from crackling sounds ("fricatives") when the affected joint is moved or touched. In another embodiment, the subject suffers from muscle spasms or bracing. In another embodiment, the subject suffers from tendon contracture. In another embodiment, the method described provides relief for painful joints. In another embodiment, the method described treats the underlying cause of joint pain. Each possibility represents a separate embodiment of the present invention. Osteoarthritis

[0137] In one embodiment, one or more lugs of the assembled footwear disclosed herein are designed to treat osteoarthritis. In another embodiment, the subject suffers from osteoarthritis of the lower limbs. In another embodiment, the subject suffers from osteoarthritis of the hip joint. In another embodiment, the subject suffers from osteoarthritis of the spine. In another embodiment, the subject suffers from osteoarthritis of the ankle. In another embodiment, the subject suffers from joint effusion (basically water in the knee). Each possibility represents a separate embodiment of the present invention.

[0138] In another embodiment, the subject is at risk for osteoarthritis. In another embodiment, the subject is exposed to increased mechanical stress on the joint. In another embodiment, the subject suffers from congenital or pathogenic bone misalignment. In another embodiment, the subject is overweight or obese. In another embodiment, the subject suffers from reduced muscle strength supporting the joint, peripheral neuropathy, uncoordinated movements that place excessive force on joints, ligaments, muscles, tendons, or any combination thereof. Each possibility represents a separate embodiment of the present invention.

[0139] In another embodiment, the subject suffers from osteophytes. In another embodiment, the method described herein inhibits narrowing of the joint space. In another embodiment, the method described herein expands the joint space. In another embodiment, the method described herein inhibits an increase in subchondral bone density. In another embodiment, the method described herein decreases subchondral bone density. In another embodiment, the method described herein increases the water content of the cartilage. In another embodiment, the method described herein increases the proteoglycan content of the cartilage. In another embodiment, the method described herein inhibits pericapsular inflammation. In another embodiment, the method described herein inhibits "spurs" or osteophytes forming at the joint margins. In another embodiment, the method described herein is used as a preventative measure for subjects at risk for osteoarthritis. In another embodiment, the subject at risk for osteoarthritis is a subject whose sibling suffers from osteoarthritis. Each possibility represents a separate embodiment of the present invention.

[0140] In another embodiment, the osteoarthritis is primary systemic lymph node osteoarthritis. In another embodiment, the osteoarthritis is erosive osteoarthritis. In another embodiment, the osteoarthritis is inflammatory osteoarthritis. In another embodiment, the osteoarthritis is secondary osteoarthritis, caused by other factors but with the same resulting pathology as primary osteoarthritis. Each possibility represents a separate embodiment of the present invention.

[0141] In another embodiment, osteoarthritis of the lower limbs (OA) is characterized by pain, stiffness, swelling, inflammation, cartilage degeneration, osteophytes, joint space narrowing, effusion, muscle atrophy, decreased neuromuscular control, decreased proprioception, bracing, pathological moments, gait disturbance, lameness, compensatory gait, painful gait, gait asymmetry, muscular guarding, ligamentous laxity, capsular laxity, ligamentous stretching, capsular stretching, decreased step length, or any combination thereof. Each possibility represents a separate embodiment of the present invention. Lower limb musculoskeletal pain

[0142] In another embodiment, "pain" as used herein comprises sharp pain. In another embodiment, "pain" as used herein comprises a burning sensation in the associated muscles and tendons. In another embodiment, "pain" as used herein comprises ongoing pain. In another embodiment, "pain" as used herein is momentary pain. In another embodiment, "pain" as used herein comprises seasonal (winter, summer, or due to weather changes) pain. In another embodiment, "pain" as used herein comprises activity-specific pain, such as pain associated with sports or any other physical activity. Each possibility represents a separate embodiment of the present invention.

[0143] In another embodiment, the lower extremity musculoskeletal pain comprises anterior knee pain.In another embodiment, the lower extremity musculoskeletal pain comprises patellofemoral joint pain.Each possibility represents a separate embodiment of the present invention.

[0144] In another embodiment, lower extremity musculoskeletal pain results from two types of trauma: acute trauma and cumulative (overuse) trauma. In another embodiment, acute trauma occurs when the loads placed on the body during work exceed the tolerance of the body structures supporting it. In another embodiment, lower extremity musculoskeletal pain is associated with a large single loading condition. In another embodiment, lower extremity musculoskeletal pain is a violent lateral impact to a joint, such as but not limited to the knee. In another embodiment, lower extremity musculoskeletal pain is a rare extreme force applied to a joint. In another embodiment, overuse trauma occurs when the loads placed on the body during work are not large enough to cause a sudden failure of one or other of the underlying body structures (bones, muscles, tendons, and ligaments), but these structures wear down and become less tolerant due to repeated loading. In another embodiment, lower extremity musculoskeletal pain results from the "wear and tear" of the body structures. Each possibility represents a separate embodiment of the present invention.

[0145] In another embodiment, the musculoskeletal pain of the lower extremities results from stress fractures and shin splints. In another embodiment, the musculoskeletal pain of the lower extremities results from ankle and metacarpal fractures (acute injuries). In another embodiment, the musculoskeletal pain of the lower extremities results from bursitis. In another embodiment, the musculoskeletal pain of the lower extremities results from rheumatism. In another embodiment, the musculoskeletal pain of the lower extremities results from cartilage tears. Each possibility represents a separate embodiment of the present invention.

[0146] In another embodiment, the musculoskeletal pain of the lower extremities is the result of osteoarthritis of the lower extremities. In another embodiment, the musculoskeletal pain of the lower extremities is the result of piriformis syndrome. In another embodiment, the musculoskeletal pain of the lower extremities is the result of vertebral bursitis. In another embodiment, the musculoskeletal pain of the lower extremities is sacroiliac joint pain. In another embodiment, the musculoskeletal pain of the lower extremities causes palpable tenderness of the greater trochanter. In another embodiment, the musculoskeletal pain of the lower extremities is caused by hamstring muscle tension. In another embodiment, the musculoskeletal pain of the lower extremities is caused by hamstring injury. Each possibility represents a separate embodiment of the present invention.

[0147] In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of bursitis. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of knee beating (hyperkeratosis). In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of meniscal injury. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of meniscal injury. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of degenerative joint disease. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of degenerative lower extremity joint disease. Each possibility represents a separate embodiment of the present invention.

[0148] In another embodiment, the lower extremity musculoskeletal pain is a direct result of bursitis (such as incidental bursitis, prepatellar bursitis, etc.). In another embodiment, the bursitis develops in response to frictional stress directly applied to the bursa of the knee. In another embodiment, the bursitis is purulent bursitis. In another embodiment, the lower extremity musculoskeletal pain is associated with tenderness and swelling above the patella. Each possibility represents a separate embodiment of the present invention.

[0149] In another embodiment, the lower extremity musculoskeletal pain is a direct result of hyperkeratosis. In another embodiment, the hyperkeratosis is an acute and extreme form of bursitis. Each possibility represents a separate embodiment of the present invention.

[0150] In another embodiment, the lower extremity musculoskeletal pain is a direct result of meniscal injury and / or damage. In another embodiment, meniscal injury / damage is typically caused by high rate forces applied to the knee, or large rotational forces, for example, when the knee is bent or twisted under load. Each possibility represents a separate embodiment of the present invention.

[0151] In another embodiment, the lower extremity musculoskeletal pain is a direct result of a stress fracture / stress response injury. In another embodiment, the term "stress response" refers to bone having evidence of remodeling but no radiological evidence of fracture. In another embodiment, the stress response / fracture is the result of repeated micro-trauma to the bone, which occurs when the applied force exceeds the bone's maximum strength and the natural process of bone adapting to stress is interrupted. In another embodiment, the stress fracture is associated with the tibia or femur or foot. In another embodiment, the stress fracture is associated with the fibula. Each possibility represents a separate embodiment of the present invention.

[0152] In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of an ankle sprain. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of anterior compartment syndrome. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of lateral compartment syndrome. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of plantar fasciitis. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of Achilles tendinitis. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of a plantar corn. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of hallux valgus. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of interdigital neuroma. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of tarsal tunnel syndrome. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of little toe deformity. In another embodiment, the musculoskeletal pain of the lower extremities is a direct result of psoriatic arthritis. Each possibility represents a separate embodiment of the present invention.

[0153] In another embodiment, the lower extremity musculoskeletal pain is heel pain. In another embodiment, the lower extremity musculoskeletal pain is a direct result of acquired flat feet. In another embodiment, the lower extremity musculoskeletal pain is associated with a presumed occurrence in abnormal pronation of the foot. In another embodiment, the lower extremity musculoskeletal pain is associated with a defective gait pattern. In another embodiment, the lower extremity musculoskeletal pain is associated with a defective standing posture. Each possibility represents a separate embodiment of the present invention. Spine-related disorders

[0154] In another embodiment, one or more lugs of the assembled footwear may be designed to treat a subject suffering from a spinal disorder, spinal pathology, spinal injury, and / or spine-related pathology.

[0155] In another embodiment, one or more projections of the assembled footwear may be designed to improve proprioceptive and / or kinesthetic control of gait in subjects with spinal pathologies described herein. In another embodiment, spinal pathologies and / or effects associated with spinal pathologies such as pain and impaired gait may be treated and even cured by modifying the center of pressure (COP) at which the foot contacts the ground. In another embodiment, modifying the center of pressure (COP) at which the foot contacts the ground is performed by calibrating the device (footwear) of the present invention. In another embodiment, the COP is modified or modified via perturbations induced by the projections disclosed herein. In another embodiment, the device of the present invention changes the movement pattern of the lower limbs by modifying the COP. In another embodiment, one or more projections of the assembled footwear are designed to change the movement pattern of the lower back muscles by modifying the COP. In another embodiment, the device of the present invention changes the movement or loading pattern of the spine and nearby musculoskeletal tissues by modifying the COP. In another embodiment, one or more lugs of the assembled footwear are designed to efficiently enable performance of the methods provided herein by effecting a controlled change in movement patterns while avoiding injury, trauma, or combinations thereof (such as, but not limited to, falls, damaging gait, damaging lower extremity neuromuscular control or activity, etc.) to the subject using the assembled footwear. Each possibility represents a separate embodiment of the present invention. urinary incontinence

[0156] In another embodiment, the assembled footwear described herein is used to treat a subject suffering from urinary incontinence. The assembled footwear described herein is used to treat a subject suffering from frequent urination. In another embodiment, the assembled footwear described herein is used to treat a subject suffering from urgency, which is a sudden and irresistible urge to urinate along with bladder discomfort. In another embodiment, the assembled footwear described herein is used to treat a subject suffering from frequent urination at night (nocturia).

[0157] In another embodiment, the subject suffering from urinary incontinence or urinary frequency is a menopausal woman.In another embodiment, the subject suffering from urinary incontinence is a postmenopausal woman.

[0158] In another embodiment, subjects who may benefit from treatment with the assembled footwear described herein include those with benign prostatic hyperplasia, congestive heart failure, cystocele, diabetes mellitus, diabetes insipidus, overactive bladder, prostate cancer, central diabetes insipidus, nephrogenic diabetes insipidus, diabetes mellitus (type 1 or type 2), high solute load overdose (e.g., mannitol therapy in hospitals or use of radiocontrast agents for radiation procedures), salt-wasting kidney disease (Bartter's syndrome), fluid overdose, diuretic use, use, interstitial cystitis, multiple sclerosis, Parkinson's disease, sequelae of kidney stones, urethral stricture, urinary tract infection, anatomical abnormalities, overactive bladder (also called urge incontinence, which may result from infection, cystitis, bladder tumor, or neurogenic bladder), psychological factors, stress incontinence (which may be related to pregnancy, estrogen deficiency, or pelvic surgery), injury from prostate surgery, neurogenic bladder, atrophic urethritis, delirium, or any combination thereof.

[0159] In another embodiment, a subject who may benefit from treatment with the assembled footwear described herein suffers from muscle wasting. In another embodiment, a subject who may benefit from treatment with the assembled footwear described herein suffers from cachexia. In another embodiment, a subject who may benefit from treatment with the assembled footwear described herein suffers from congestive heart disease.

[0160] In another embodiment, subjects who may benefit from treatment with the assembled footwear described herein suffer from weakened pelvic floor muscles that are unable to retain urine in the bladder when intraperitoneal pressure increases (e.g., when coughing, laughing, etc.). In another embodiment, subjects who may benefit from treatment with the assembled footwear described herein suffer from urge incontinence, or the inability to control the passage of urine when they feel the need to urinate. In another embodiment, subjects who may benefit from treatment with the assembled footwear described herein suffer from overflow incontinence. In another embodiment, overflow incontinence occurs when urine continues to flow long after the subject has finished urinating. In another embodiment, subjects who may benefit from treatment with the assembled footwear described herein suffer from mixed incontinence.

[0161] In another embodiment, subjects who may benefit from treatment with the assembled footwear described herein are women who suffer from stress urinary incontinence, urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence, or a combination thereof. Neurological disease or condition

[0162] According to some embodiments, a kit and / or assembled footwear for treating a neurological disease or a symptom associated therewith is provided. In one embodiment, one or more projections of the assembled footwear are designed to improve balance of a subject suffering from a neurological disease through improved muscle coordination, motor learning, normalization of gait patterns, and desired alignment of joints in the lower limbs and lower back. For example, one or more projections of the assembled footwear are designed to improve dysmetria of a subject suffering from a neurological disease through mechanisms of brain plasticity, motor learning, improved and accurate proprioception and interpretation of proprioceptive and vestibular inputs, and improved muscle coordination and / or neural coordination of a subject suffering from a neurological disease. For example, one or more projections of the assembled footwear are designed to reduce muscle tone of a subject suffering from a neurological disease through desired alignment of joints in the lower limbs and lower back, and reduced muscle tone in response to a congenital sway of a subject suffering from a neurological disease. For example, one or more projections of the assembled footwear are designed to lower the energy cost of walking in subjects with neurological disorders through improved muscle coordination, motor learning, normalization of gait patterns, and desired alignment of joints of the lower limbs and lower back in subjects with neurological disorders. For example, one or more projections of the assembled footwear are designed to increase neural sprouting in subjects with neurological disorders through repetitive stimulation of desired movement patterns (central nervous system) and repetitive muscle activation (peripheral nervous system). For example, one or more projections of the assembled footwear are designed to increase the plasticity of the nervous system in subjects with neurological disorders. For example, one or more projections of the assembled footwear are designed to prevent joint pain, deformity, and contractures (both in joints and various muscles) in subjects with neurological disorders through redistribution of loads in joints, improvement of muscle activity, and reduction of muscle tone. For example, one or more lugs of the assembled footwear are designed to prevent falls in subjects suffering from neurological disorders through improved balance, reduced muscle tone, improved dysmetria, and improved alignment and posture.

[0163] In some embodiments, the kit and / or assembled footwear disclosed herein is used in a method for improving control over gait function. In some embodiments, the design of one or more projections of the assembled footwear is based on the unexpected discovery that various gait-related symptoms caused by neuropathy can be treated, improved, and / or completely cured by modifying the center of pressure (COP) of the foot at the ground. In another embodiment, the modification of the center of pressure (COP) of the foot at the ground is performed by calibrating the device (footwear) of the present invention. In another embodiment, the COP is modified or modified via perturbations induced by the projections disclosed herein. In another embodiment, the one or more projections of the assembled footwear are designed to change the movement pattern of the lower limbs by modifying the COP. In another embodiment, the one or more projections of the assembled footwear are designed to efficiently enable the performance of the methods provided herein by effecting a controlled change in the movement pattern while avoiding injury, injury, trauma, or combinations thereof (such as, but not limited to, falls, damaging gait, damaging lower limb neuromuscular control or activity, etc.) of the subject using the device. subject

[0164] In another embodiment, the subject is an athlete.In another embodiment, the subject suffers from pain, for example, leg pain, back pain, or neuropathic pain.

[0165] In another embodiment, the subject suffers from a congenital disorder of the joints. In another embodiment, the subject suffers from diabetes. In another embodiment, the subject suffers from an inflammatory disease (e.g., Perthes disease, Lyme disease, chronic arthritis, etc.). Each possibility represents a separate embodiment of the present invention.

[0166] In another embodiment, the subject suffers from rheumatoid arthritis. In another embodiment, the subject suffers from Achilles tendon injury and tendonitis. In another embodiment, the subject suffers from adductor strain. In another embodiment, the subject suffers from an ankle sprain. In another embodiment, the subject suffers from an anterior cruciate ligament injury. In another embodiment, the subject suffers from calcaneal bursitis. In another embodiment, the lower limb musculoskeletal pain is coccygeal pain. In another embodiment, the subject suffers from compartment syndrome. In another embodiment, the subject suffers from iliotibial band syndrome. In another embodiment, the subject suffers from medial collateral ligament injury and lateral collateral ligament injury. In another embodiment, the subject suffers from dysesthesias femoral neuralgia. In another embodiment, the subject suffers from Morton's neuroma. In another embodiment, the subject suffers from osteitis pubis. In another embodiment, the subject suffers from patellofemoral syndrome. In another embodiment, the subject suffers from claw foot bursitis or tendonitis. In another embodiment, the subject is suffering from piriformis syndrome. In another embodiment, the subject is suffering from plantar fasciitis. In another embodiment, the subject is suffering from a posterior cruciate ligament injury. In another embodiment, the subject is suffering from prepatellar bursitis. In another embodiment, the subject is suffering from trochanteric bursitis. Each possibility represents a separate embodiment of the present invention.

[0167] In another embodiment, the subject of the present invention further suffers from a gait disorder. In another embodiment, the subject of the present invention is a human subject capable of walking or running with the apparatus described herein. In another embodiment, the subject of the present invention is a human subject capable of walking or running with the footwear 10. Each possibility represents a separate embodiment of the present invention. In another embodiment, the gait disorder is gait asymmetry, shuffling gait, gait with unsteady movements, or any combination thereof. In another embodiment, the gait disorder is caused by a degenerative joint disease. Each possibility represents a separate embodiment of the present invention.

[0168] In another embodiment, the subject is able to walk. In another embodiment, the subject is able to walk with the aid of a walking aid, such as, but not limited to, a walking cane. In another embodiment, the subject is able to walk unaided. In another embodiment, walking is defined as the act of shifting balance and support from one foot to the other while moving in a particular direction. Each possibility represents a separate embodiment of the present invention. treatment

[0169] In another embodiment, the method described herein includes exercising with the assembled footwear described herein. In another embodiment, the exercise is walking or any other form of ambulatory exercise. In another embodiment, the improvement is measured in a gait laboratory. In another embodiment, an improvement in the subject's physical condition is observed using the method described herein. In another embodiment, the treatment is an improvement in the subject's physiological condition. In another embodiment, the treatment is an improvement in the subject's mental condition. In another embodiment, the treatment is an improvement in the subject's health. In another embodiment, the treatment is relieving pain, e.g., joint pain. In another embodiment, the treatment is relieving tenderness. In another embodiment, the treatment is relieving stiffness. In another embodiment, the treatment is relieving locking. In another embodiment, the treatment is relieving exudate. In another embodiment, the treatment is inhibiting cartilage loss. In another embodiment, the treatment is inducing neocartilage formation. In another embodiment, the treatment is increasing movement. In another embodiment, the treatment is increasing movement secondary to pain. In another embodiment, the treatment is inhibiting localized muscle atrophy. In another embodiment, the treatment is to reverse local muscle atrophy. In another embodiment, the treatment is to induce muscle building. In another embodiment, the treatment is to induce differentiated muscle building. Each possibility represents a separate embodiment of the present invention.

[0170] In another embodiment, the treatment is to improve gait. In another embodiment, the treatment is to improve balance. In another embodiment, the treatment is to improve impairments in proprioception, balance, muscle strength, or any combination thereof. In another embodiment, the treatment is to halt impairments in proprioception, balance, muscle strength, or any combination thereof. In another embodiment, the treatment is to specifically improve impairments in proprioception, balance, muscle strength, or any combination thereof associated with certain degenerative joint diseases. In another embodiment, the treatment is to specifically improve impairments in proprioception, balance, muscle strength, or any combination thereof associated with lower extremity arthritis. In another embodiment, the treatment is to specifically improve impairments in proprioception, balance, muscle strength, or any combination thereof associated with osteoarthritis of the hip, ankle, foot, or knee. In another embodiment, the treatment is to reduce falls. Each possibility represents a separate embodiment of the present invention.

[0171] In another embodiment, the treatment is to manipulate step length. In another embodiment, the treatment is to reduce the "step length difference". In another embodiment, the treatment is to manipulate single leg support. In another embodiment, the treatment is to manipulate lateral / medial traction angle. In another embodiment, the treatment is to calibrate the gait cycle (40:40:20). In another embodiment, the treatment is to manipulate cadence. In another embodiment, the treatment is to manipulate center of pressure (COP). In another embodiment, the treatment is to correct mean hip motion, knee motion, ankle motion, or any combination thereof in the sagittal, frontal, and transverse planes. In another embodiment, the treatment is to improve walking pace or speed. In another embodiment, the treatment is to increase walking pace or speed. In another embodiment, the improved walking pace or speed is to reach a walking speed goal of 1.6-4 km / hour. In another embodiment, the improved walking pace or speed is to reach a walking speed goal of 1.6-4 km / hour for at least 2 minutes. In another embodiment, the improvement in walking pace or speed is to reach a walking speed goal of 1.6-4 km / hour for at least 5 minutes. In another embodiment, the improvement in walking pace or speed is to reach a walking speed goal of 1.6-4 km / hour for at least 10 minutes. In another embodiment, the improvement in walking pace or speed is to reach a walking speed goal of 1.6-4 km / hour for at least 15 minutes. In another embodiment, the improvement in walking pace or speed is to reach a walking speed goal of 2-3.5 km / hour for at least 2 minutes. In another embodiment, the improvement in walking pace or speed is to reach a walking speed goal of 2-3.5 km / hour for at least 5 minutes. In another embodiment, the improvement in walking pace or speed is to reach a walking speed goal of 2-3.5 km / hour for at least 10 minutes. In another embodiment, the improvement in walking pace or speed is to reach a walking speed goal of 2-3.5 km / hour for at least 15 minutes.In another embodiment, the improved walking pace or speed is to reach a walking speed goal of 2.5-3.2 km / hour for at least 2 minutes. In another embodiment, the improved walking pace or speed is to reach a walking speed goal of 2.5-3.2 km / hour for at least 5 minutes. In another embodiment, the improved walking pace or speed is to reach a walking speed goal of 2.5-3.2 km / hour for at least 10 minutes. In another embodiment, the improved walking pace or speed is to reach a walking speed goal of 2.5-3.2 km / hour for at least 15 minutes. Each possibility represents a separate embodiment of the present invention.

[0172] In another embodiment, the treatment is to relax a stiff knee, hip, ankle, or foot. In another embodiment, the treatment is to correct abnormal flexion or extension during stance phase. In another embodiment, the treatment is to correct limited hip extension at toe off. In another embodiment, the treatment is to correct abnormal muscle activity of the lower limbs. In another embodiment, the treatment is to correct overactivity of the quadriceps during standing. In another embodiment, the treatment is to correct (shorten or lengthen) semitendinosus activity. In another embodiment, the treatment is to correct increased triceps surae activity during swing phase. In another embodiment, the treatment is to correct inactivity of the tibialis anterior at the end of swing phase. In another embodiment, the treatment is to adjust any lower limb muscle. Each possibility represents a separate embodiment of the present invention.

[0173] In another embodiment, the method described herein further comprises a combination therapy comprising the use of the assembled footwear described herein and an appropriate medication. In another embodiment, one skilled in the art can easily diagnose a subject suffering from a disease or condition, for example as described herein, and prescribe an appropriate medication. In another embodiment, the medication is a pain reliever, for example, acetaminophen. In another embodiment, the medication is a nonsteroidal anti-inflammatory drug (NSAID), for example, ibuprofen. In another embodiment, the medication is a COX-2 selective inhibitor, for example, celecoxib. In another embodiment, the medication is a topical NSAID, for example, diclofenac. In another embodiment, the medication is an opioid pain reliever, for example, morphine or codeine. In another embodiment, the medication is a glucocorticoid, for example, hydrocortisone injected into the knee. In another embodiment, the medication is topical capsaicin. In another embodiment, the medication is an articular injection of hyaluronic acid. Each possibility represents a separate embodiment of the present invention.

[0174] In another embodiment, the therapeutic outcomes provided herein are realized immediately after the first use of the assembled footwear described herein. In another embodiment, the therapeutic outcomes provided herein are realized after walking 10-1,000,000 meters with the assembled footwear described herein. In another embodiment, the therapeutic outcomes provided herein are realized after walking 50-100,000 meters with the assembled footwear described herein. In another embodiment, the therapeutic outcomes provided herein are realized after walking 500-10,000 meters with the assembled footwear described herein. In another embodiment, the therapeutic outcomes provided herein are realized after walking 500-5,000 meters with the assembled footwear described herein. In another embodiment, the therapeutic outcomes provided herein are realized after walking 500-3,000 meters with the assembled footwear described herein. Each possibility represents a separate embodiment of the present invention.

[0175] In another embodiment, the outcome of the treatment provided herein is correction of pathology associated with lower extremity osteoarthritis. In another embodiment, the outcome of the treatment provided herein is correction of osteoarthritis of the hip, ankle, foot, or knee. In another embodiment, the outcome of the treatment provided herein is improvement of lower extremity osteoarthritis. In another embodiment, the outcome of the treatment provided herein is inhibition of symptoms associated with lower extremity osteoarthritis. Each possibility represents a separate embodiment of the present invention.

[0176] In another embodiment, the therapeutic outcomes provided herein are realized while the subject is wearing the assembled footwear described herein. In another embodiment, the therapeutic outcomes provided herein are realized when the subject is walking barefoot. Each possibility represents a separate embodiment of the present invention.

[0177] In another embodiment, the differentiation muscle building comprises inducing muscle building at sites of muscle atrophy. In another embodiment, the differentiation muscle building is inducing muscle building at sites of muscle weakness. In another embodiment, the differentiation muscle building is inducing muscle building at sites of muscle damage. Each possibility represents a separate embodiment of the present invention.

[0178] In another embodiment, the assembled footwear disclosed herein has an immediate effect with respect to the treatment or management of the diseases, pathologies, and / or pain described herein. In another embodiment, a barefoot subject experiences a short-term immediate effect after walking for 1-5 minutes in the assembled footwear. In another embodiment, the assembled footwear disclosed herein has an immediate effect with respect to the treatment or management of the diseases, pathologies, and / or pain described herein. In another embodiment, a barefoot subject experiences a short-term immediate effect after walking for 10-60 minutes in the assembled footwear. In another embodiment, a barefoot subject experiences a short-term immediate effect after walking for 30-600 minutes in the assembled footwear. In another embodiment, a barefoot subject experiences a short-term immediate effect after walking for 1-10 hours (hrs) in the assembled footwear. In another embodiment, a barefoot subject experiences a short-term immediate effect after walking for 5-1000 hours (hrs) in the assembled footwear. In another embodiment, the short-term immediate effect occurs in barefoot subjects after walking in the assembled footwear for 12-96 hours (hrs). In another embodiment, the short-term immediate effect occurs in barefoot subjects after walking in the assembled footwear for 1-10 days. In another embodiment, the short-term immediate effect occurs in barefoot subjects after walking in the assembled footwear for 7-21 days. In another embodiment, the short-term immediate effect occurs in barefoot subjects after walking in the assembled footwear for 5-30 days. Each possibility represents a separate embodiment of the present invention.

[0179] In another embodiment, the effect is observed in a barefoot subject after walking in the assembled footwear for 1-2 months. In another embodiment, the effect is observed in a barefoot subject after walking in the assembled footwear for 1-24 months. In another embodiment, the effect is observed in a barefoot subject after walking in the assembled footwear for 2-6 months. In another embodiment, the effect is observed in a barefoot subject after walking in the assembled footwear for 4-10 months. In another embodiment, the effect is observed in a barefoot subject after walking in the assembled footwear for 6-48 months. In another embodiment, the effect is observed in a barefoot subject after walking in the assembled footwear for 12-24 months. In another embodiment, the effect is observed in a barefoot subject after walking in the assembled footwear for 10-30 months. Each possibility represents a separate embodiment of the present invention.

[0180] In another embodiment, the treatment is a process by which a subject's disease or symptoms are improved. In another embodiment, the treatment is an improvement over time. In another embodiment, the treatment is a continued improvement over time. In another embodiment, the progress or improvement is a decrease in any of the measures described herein. In another embodiment, the progress or improvement is measured in a gait lab. In another embodiment, the progress or improvement is measured by radiological methods. In another embodiment, radiological methods for measuring progress, treatment, and / or improvement are known to those skilled in the art (e.g., but not limited to, x-ray, MRI, etc.). In another embodiment, the progress or improvement is measured by a pain questionnaire. In another embodiment, the progress or improvement is measured by a physical examination, including, but not limited to, testing range of motion, such as flexion, extension, dorsiflexion / plantar flexion (ankle), muscle circumference, internal / external rotation (hip), abduction / adduction (hip and knee), effusion, hot / warm knee, or any combination thereof. In another embodiment, the progress or improvement is measured by visual clinical gait assessment. Each possibility represents a separate embodiment of the present invention.

[0181] In another embodiment, progress or improvement is measured in a gait lab and includes measuring speed, step length increase, step length difference (symmetry), single support (goal to reach 40%), single support difference (symmetry), double support, thigh in / out, flexion / extension, range of motion (rom), flexion / extension, or any combination thereof. Each possibility represents a separate embodiment of the present invention.

[0182] In another embodiment, the assembled footwear described herein is prescribed to a subject according to the subject's physical condition. In another embodiment, the assembled footwear described herein is prescribed to a subject according to the subject's medical condition. In another embodiment, the assembled footwear described herein is prescribed to a subject according to the subject's medical history. In another embodiment, the prescription includes instructions on how to use the assembled footwear, more precisely which lugs to assemble on the outsole of the assembled footwear. In another embodiment, the prescription includes instructions on intensity of use, daily use, or daily distance. In another embodiment, the prescription for a subject with a step length of 45 cm or less includes using the assembled footwear for 10 to 40 minutes of walking per day. In another embodiment, the prescription for a subject with a step length of 45 cm or less includes using the assembled footwear for 10 to 40 minutes of walking every other day. Each possibility represents a separate embodiment of the present invention.

[0183] In another embodiment, a medium prescription is applied to subjects having a step length of 45-60 cm. In another embodiment, a medium prescription is applied to subjects having a step length of 50-60 cm. In another embodiment, a medium prescription is applied to subjects having a step length of 60-65 cm. In another embodiment, the medium prescription comprises use of the assembled footwear for 5-20 minutes of walking per day. In another embodiment, the medium prescription comprises use of the assembled footwear for 10-20 minutes of walking per day. In another embodiment, the medium prescription comprises use of the assembled footwear for 5-15 minutes of walking per day. Each possibility represents a separate embodiment of the present invention.

[0184] In another embodiment, the high prescription is applied to subjects having a step length of 65 cm or greater. In another embodiment, the high prescription is applied to subjects having a step length of 60 m or greater. In another embodiment, the high prescription comprises use of the assembled footwear for 5-20 minutes of walking per day. In another embodiment, the high prescription comprises use of the assembled footwear for 10-20 minutes of walking per day. In another embodiment, the high prescription comprises use of the assembled footwear for 5-15 minutes of walking per day. Each possibility represents a separate embodiment of the present invention.

[0185] In another embodiment, any of the regimens described herein comprise increasing the daily hours of use with an improvement in the subject's step length. In another embodiment, any of the regimens described herein comprise increasing the daily hours of use with an improvement in the subject's level of function. In another embodiment, any of the regimens described herein comprise increasing the daily hours of use with a decrease in the subject's pain. In another embodiment, any of the regimens described herein comprise increasing the daily hours of use with an improvement in the subject's disease or condition as described herein. In another embodiment, any of the regimens described herein further comprise administering medication to the subject according to the subject's medical condition. Each possibility represents a separate embodiment of the present invention.

[0186] In another embodiment, the regimen described herein further comprises selecting a new set of protrusions as the subject's disease or condition improves or worsens.

[0187] Additional objects, advantages, and novel features of the present invention will become apparent to those skilled in the art upon examination of the following examples, which are not intended to be limiting, and each of the various embodiments and aspects of the invention described hereinabove and as claimed below finds experimental confirmation in the following examples.

Claims

**Claim 1** A footwear for manipulating gait parameters, comprising an outsole, wherein the outsole has at least one recess located on the ground contact surface or outer surface of the outsole, (a) a depth of 10% to 95% of the maximum thickness of the outsole, and (b) an area covering 10% to 95% of the entire ground contact surface or outer surface of the outsole at least one recess having; two curved protrusions protruding from the ground contact surface or outer surface of the outsole and adapted to be removably attached to the at least one recess, each having a different curved outer contour and occupying 50% to 95% of the area of the at least one recess, two curved protrusions; **Claim 2** The footwear according to claim 1, wherein the two curved protrusions are asymmetric. **Claim 3** The footwear according to claim 1, wherein the two curved protrusions are defined by various arches with different radii in contact with each other. **Claim 4** The footwear according to claim 1, wherein at least one outer contour of the two curved protrusions and the outer contour of the outsole form a continuous curved portion. **Claim 5** The footwear according to claim 1, wherein each curved protrusion comprises a portion connectable to the recess and a grounding portion, and the portion connectable to the recess is harder than the grounding portion. **Claim 6** The footwear according to claim 1, wherein each protrusion is different with respect to the position of the top, the degree of protrusion, the Shore hardness, or any combination thereof. **Claim 7** The footwear according to claim 1, wherein the base of a single protrusion occupies at least 60% of the area of a single recess, and the first perimeter of the base of the single protrusion is adapted to coincide with the second perimeter of the single recess. **Claim 8** The footwear according to claim 1, wherein for each protrusion, at least the position of the top is determined based on at least one gait parameter and / or balance measured for a group of subjects. **Claim 9** The gait parameters are selected from foot alignment, knee alignment, speed, swing phase and stance phase, double support time, ground reaction force, impact, propulsion force during habitual walking, knee alignment, center of pressure, symmetry, walking speed, step time, step length, stride length, step width, foot angle, and the boundary between walking and running. **Claim 10** The footwear according to claim 8, wherein the subject group is determined as subjects having at least two common characteristics selected from age, gender, foot size, walking behavior, and lesions.

11. The footwear according to claim 10, wherein the subjects having the common walking behavior are subjects having at least two similar walking parameters.

12. For each protrusion, the curvature of the protrusion is determined based on the at least one walking parameter and / or the balance parameter of the subject measured for the subject group. The footwear according to claim 8.

13. For each protrusion, the contour of the base of the protrusion is determined based on the at least one walking parameter and / or the balance parameter of the subject measured for the subject group. The footwear according to claim 8.

14. A footwear kit for manipulating walking parameters, comprising: the footwear includes an outsole, and the outsole at least one recess located on the ground contact surface or outer surface of the outsole, (a) having a depth of 10% to 95% of the maximum thickness of the outsole, and (b) covering an area of 10% to 95% of the entire ground contact surface or outer surface of the outsole at least one recess having; two curved protrusions protruding from the ground contact surface or outer surface of the outsole and adapted to be removably attached to the at least one recess, each having a different curved outer contour and occupying 50% to 95% of the area of the at least one recess, two curved protrusions A footwear kit comprising.

15. The footwear kit according to claim 14, wherein the two curved protrusions are at least 10% higher than the maximum depth of the at least one recess at the top.

16. Each of the protrusions has a top, and the position of the top is adapted to improve at least one walking-related lesion. The footwear kit according to claim 14.

17. The height at the top of each protrusion is adapted to improve at least one walking-related lesion. The footwear kit according to claim 14.

18. The footwear kit according to claim 14, wherein the two curved protrusions are asymmetric.

19. The footwear kit according to claim 14, wherein the two curved protrusions are defined by various arches with different radii in contact with each other.

20. The footwear kit according to claim 14, wherein at least one outer contour of the two curved protrusions and the outer contour of the outsole form a continuous curved portion.

21. The footwear kit according to claim 14, wherein each curved protrusion includes a portion connectable to the recess and a grounding portion, and the portion connectable to the recess is harder than the grounding portion.

22. The footwear kit according to claim 14, wherein each protrusion is different with respect to at least the position of the top, the protrusion degree, the Shore hardness, or any combination thereof.

23. The footwear kit according to claim 14, wherein the base of a single protrusion occupies at least 60% of the area of a single recess, and the first perimeter of the base of the single protrusion is adapted to coincide with the second perimeter of the single recess.

24. The footwear kit according to claim 14, wherein for each protrusion, at least the position of the top is determined based on at least one walking parameter and / or balance parameter of a subject measured with respect to a group of subjects.

25. The footwear kit according to claim 24, wherein the walking parameters are selected from speed, swing phase and stance phase, double support time, ground reaction force, impact, propulsion force during habitual walking, knee alignment, foot alignment, center of pressure, symmetry, walking speed, step time, step length, stride length, step width, foot angle, and the boundary between walking and running.

26. The footwear kit according to claim 24, wherein the group of subjects is determined as subjects having at least two common characteristics selected from age, gender, foot size, walking behavior, and lesion.

27. The footwear kit according to claim 26, wherein the subjects having the common walking behavior are subjects having at least two similar walking parameters.

28. The footwear kit according to claim 24, wherein for each protrusion, the curvature of the protrusion is determined based on at least one walking parameter and / or the balance parameter of the subject measured with respect to the group of subjects.

29. The footwear kit according to claim 24, wherein for each protrusion, the contour of the base of the protrusion is determined based on at least one walking parameter and / or the balance parameter of the subject measured with respect to the group of subjects.

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