Adjustable dynamic ankle foot orthosis

Abstract

The present disclosure provides an orthopedic brace including: a leg cuff; a footplate; and a strut coupling the leg cuff to the footplate. The strut includes a first member with opposite first and second ends, a second member coupled at a first end to the first end of the first member, and a third member coupled at a first end to the second end of the first member. The brace further includes a first adjustable coupling element connecting the second member to the first member, and a second adjustable coupling element connecting the third member to the first member. The stiffness and / or bending location of the strut is adjustable based on the position of at least one of the adjustable coupling elements along the length of the first member.

Description

Adjustable Dynamic Ankle Foot OrthosisCross-Reference to Related Applications

[0001] This application claims the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 63 / 636,687, filed April 19, 2024, which is hereby incorporated by reference in its entirety.Federal Funding

[0002] This invention was made with government support under Grant No. W81XWH-20-1 -0908, awarded by the Department of Defense. The government has certain rights in the invention.Background

[0003] Unless otherwise indicated herein, the materials described in this section are not prior art to the claims in this application and are not admitted to be prior art by inclusion in this section.

[0004] Lower extremity injuries are a major cause of long-term mobility limitations. These injuries frequently lead to hospitalizations and can significantly impair physical function and quality of life. To aid recovery and restore mobility, specialized interventions and assistive devices are commonly used.

[0005] One of these assistive devices is an Ankle-Foot Orthosis (AFO), a brace configured to support the ankle and foot, improve gait, and enhance stability during walking. Typically worn on the lower leg and foot, the AFO helps control the position and movement of the ankle joint. By providing structural support and proper alignment, AFOs improve walking efficiency, reduce the risk of falls, and help users maintain a more natural gait.

[0006] However, conventional AFOs do not always deliver consistent energy return, lack adaptability to different terrains like inclines, and may cause discomfort at higher speeds for individuals with restricted joint motion.Summary

[0007] The present disclosure relates to an orthopedic brace configured to support the lower leg while allowing controlled movement of the ankle and foot. In particular, the orthopedic brace is configured to: (i) limit ankle motion in the sagittal plane, which controls up-and-down foot movement; (ii) allow natural movement in the frontal and transverse planes, such as side-to- side or rotational motions; and (iii) adjust the stiffness of a strut to accommodate changes in a user's environment, providing a dynamic and adaptable solution for various activity levels and terrain conditions.

[0008] Thus in a first aspect, the present disclosure provides an orthopedic brace including: a leg cuff; a footplate; and a strut coupling the leg cuff to the footplate. The strut includes: a firstmember having a first end and a second end opposite the first end; and a second member having a first end and a second end opposite the first end. The first end of the first member is coupled to the first end of the second member. The strut also includes a third member having a first end and a second end opposite the first end. The second end of the first member is coupled to the first end of the third member. The brace also includes a first adjustable coupling element configured to couple the second member to the first member; and a second adjustable coupling element configured to couple the third member to the first member. A stiffness and / or a bending location of the strut is configured to be adjusted based on a movement of at least one of the first adjustable coupling element or the second adjustable coupling element along a length of the first member.

[0009] Thus in a second aspect, the present disclosure provides an orthopedic brace including: a leg cuff; a footplate; and a strut mechanically coupling the leg cuff to the footplate. The leg cuff is to enable rotation in a transverse plane and / or the footplate is configured to enable rotation in a frontal plane.

[0010] These, as well as other aspects, advantages, and alternatives, should become apparent to those of ordinary skill in the art by reading the following detailed description, with reference, where appropriate, to the accompanying drawings.Brief Summary of the Drawings

[0011] Figure 1 illustrates a simplified diagram of one example orthopedic brace, according to an example embodiment.

[0012] Figure 2 illustrates an example implantation of the orthopedic brace of Figure 1.

[0013] Figure 3 illustrates a leg cuff of an orthopedic brace, according to an example embodiment.

[0014] Figures 4A and 4B each illustrate a simplified strut of an orthopedic brace, according to an example embodiment.

[0015] Figures 5A-5D illustrate mechanical properties of a strut of an orthopedic brace, according to an example embodiment.

[0016] Figures 6A and 6B illustrates another example of a strut of an orthopedic brace, according to an example embodiment.

[0017] Figures 7A and 7B illustrates another example of a strut of an orthopedic brace, according to an example embodiment.

[0018] Figures 8 A and 8B illustrates another example of a strut of an orthopedic brace, according to an example embodiment.

[0019] Figures 9A and 9B illustrates another example of a strut of an orthopedic brace, according to an example embodiment.

[0020] Figures 10A and 10B illustrates another example of a strut of an orthopedic brace, according to an example embodiment.

[0021] Figures 11 A and 1 IB illustrates an example of a footplate of an orthopedic brace, according to an example embodiment.

[0022] Figure 12 illustrates another example of a footplate of an orthopedic brace, according to an example embodiment.

[0023] Figures 13 A and 13B illustrate another example of a footplate of an orthopedic brace, according to an example embodiment.

[0024] Figure 14 illustrates a simplified diagram of another example orthopedic brace, according to an example embodiment.

[0025] Figure 15 illustrates another example of footplate of an orthopedic brace, according to an example embodiment.

[0026] Figures 16A-D illustrate a method of embedding a sensor within a footplate of an orthopedic brace, according to an example embodiment.

[0027] Figure 17 illustrates an exemplary system for controlling operation of an orthopedic brace, according to an example embodiment.

[0028] Figure 18 illustrates an exemplary server of the exemplary system of Figure 17.Detailed Description

[0029] Example devices, methods, and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as being an “example,” being “exemplary,” or being “illustrative” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The example embodiments described herein are not meant to be limiting. It should be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.

[0030] Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example embodiment may include elements that are not illustrated in the Figures.

[0031] As used herein, with respect to measurements, “about” means + / - 5%.

[0032] The present disclosure discusses the implementation of the orthopedic brace (e.g., brace) in the context of healthcare, specifically for users who are injured. The brace is designed to aid in the recovery process by providing support, limiting harmful movements, and allowing for controlled mobility during rehabilitation. The brace is configured to meet the needs of individuals recovering from lower leg injuries, ensuring both effective healing and enhanced comfort throughout the recovery period. However, it should be understood that the disclosed principles could apply as well in other contexts, not limited to the healthcare environment.

[0033] As noted above, lower extremity injuries are a major cause of long-term mobility limitations. These injuries frequently lead to hospitalizations and can significantly impair physical function and quality of life. To facilitate recovery and restore mobility, orthopedic braces are commonly used to support the injured area, reduce pain, and enhance movement.

[0034] Many individuals recovering from injury rely on orthopedic braces, such as dynamic or carbon fiber ankle-foot orthoses (AFOs), to support rehabilitation. These dynamic braces are typically constructed from advanced materials like carbon fiber, which are capable of storing and releasing energy during gait. This energy return assists in propelling the foot forward, reducing the physical effort required and making walking feel more natural while minimizing fatigue. Additionally, dynamic braces often feature adjustable stiffness settings, allowing customization based on the wearer’s activity level, injury severity, or stage of recovery. This adaptability provides tailored support to optimize both mobility and healing. Despite these benefits, challenges remain in fully restoring functional capacity and achieving pre-injury performance levels.

[0035] One of the technical issues of a dynamic brace is the inconsistent energy storage and return performance. While computer simulations indicate that adjusting strut stiffness during the fitting process could enhance energy transfer efficiency, real-world gait analysis has yet to consistently validate these theoretical improvements. Moreover, although powered ankle devices capable of dynamically adjusting stiffness throughout the gait cycle have demonstrated performance gains, their increased weight often negates the benefits. Many users report a strong preference for lighter, passive orthoses over heavier, powered alternatives, which may hinder broader adoption of more advanced, adaptive designs.

[0036] Another technical issue of current dynamic braces is the braces’ inability to effectively accommodate higher running speeds or adapt to inclined surfaces. At increased speeds, the demand for greater ankle joint motion can lead to discomfort or pain, particularly for users with restricted mobility or prior injuries. For example, individuals with conditions such asfailed ankle fusion may benefit from increased strut stiffness to limit excessive ankle motion during running. Additionally, the inability of dynamic braces to adapt to varying terrain, such as uphill or downhill slopes, can reduce their functional effectiveness. Incorporating an adjustable footplate angle to align with terrain gradients could enhance support, improve user comfort, and optimize performance during activities that involve rapid elevation changes or uneven ground.

[0037] Research has shown that during low-intensity activities, users may compensate for a stiff strut by adopting movement strategies that increase their risk of knee joint arthritis and other longterm orthopedic issues. While the stiff strut performs well during high-intensity activity, it may cause medical problems and instability during low-intensity movements. The primary concern is the risk of joint damage. Trials conducted at a consistent running speed revealed that injured service members adapted to a stiff strut by increasing knee flexion. Repetitive excessive knee flexion can contribute to arthritis and degenerative joint issues. Furthermore, a stiff strut creates high impact at heel contact, potentially affecting surrounding joints. Clinical experience also suggests that stability during standing and weight-bearing activities can be compromised by an overly stiff strut, as it restricts ankle joint motion.

[0038] To help address these technical issues, an orthopedic brace configured to support the lower leg while allowing controlled movement of the ankle and foot is provided. As mentioned above, the orthopedic brace is configured to: (i) limit ankle motion in the sagittal plane, which controls up-and-down foot movement; (ii) allow natural movement in the frontal and transverse planes, such as side-to-side or rotational motions; and (iii) adjust the stiffness of a strut to accommodate changes in a user's environment, providing a dynamic and adaptable solution for various activity levels and terrain conditions.First Orthopedic Brace Implementation

[0039] Figure 1 illustrates a simplified diagram of one example orthopedic brace 100 configured to support a lower leg of a user while allowing controlled movement of an ankle and foot of the user to help treat lower-limb overuse injuries such as stress fractures, tendinopathy, plantar fasciitis, and the like. The brace 100 includes a leg cuff 200 configured to enable rotation in a transvers plane, a strut 400, and a footplate 1100 may be configured to enable rotation in a frontal plane. The strut 400 is configured to mechanically couple the cuff 200 to the footplate 1100.

[0040] As is described further below, the cuff 200 interfaces with the user’s lower leg and includes a rotational mechanism (e.g., band) that may be configured to allow for controlled transverse plane motion, helping to improve gait dynamics and user mobility. The strut 400 helps totransmit a load between the leg and foot during movement, like walking, running, standing, climbing stairs, or the like. The footplate 1100 provides structural support to the user's foot and allows rotation in the frontal plane i.e., permits movement like inversion and eversion.

[0041] In some examples, the brace 100 is configured to be placed within a footwear of a user. Figure 2 illustrates an example implantation of the orthopedic brace 100 placed within a footwear 150. Current orthopedic braces often require modifications to the footwear to accommodate external components such as the footplate 1100. However, as depicted in Figure 2, to eliminate the need for any modification (e.g., hole) in the footwear, the brace 100 allows the footplate 1100 to extend through the back. As a result, the footplate 1100 helps to enable the brace 100 to fit within the footwear.

[0042] The present description further discusses implementations of the brace 100, with particular reference to anatomical planes, which are imaginary flat surfaces used to divide a body into distinct sections. These planes are commonly used to describe human movement and body orientation, and are helpful for understanding the functional behavior of the brace 100, as well as any additional embodiments described herein.

[0043] As depicted in Figure 2, relative to the brace 100, the anatomical planes are as follows: (i) a sagittal plane, which divides the body into left and right halves and movements in this plane typically involve flexion and extension; (ii) a frontal (coronal) plane, which divides the body into front (anterior) and back (posterior) halves and movements along this plane include abduction and adduction; and (iii) a transverse (horizontal) plane, which divides the body into upper (superior) and lower (inferior) halves and rotational movements, such as internal and external rotation, occur in this plane.Leg Cuff

[0044] Figure 3 illustrates an example of the leg cuff 200. In this example, the leg cuff 200 includes two components: a collar 210 and a band 220. The collar 210 is configured to surround and support a user’s lower leg, while the band 220 is positioned relative to the collar 210 and is configured to enable rotational movement of the collar — and consequently, the leg — in the transverse plane.

[0045] The collar 210 further includes an integrated tensioner 230, which is configured to allow a user to adjust the tightness or compression of the collar 210 around the leg. The tensioner 230 may include a ratcheting dial 232 and a cable 234, which work together to apply and maintain adjustable, circumferential tension.

[0046] In some examples, the collar 210 may be formed as a single molded component and in other examples the collar 210 may be formed as multiple articulated sections configured toconform to the anatomical contours of the lower leg near the knee. Materials may include metals, thermoplastic, carbon fiber, or molded foam. In some examples, the collar 210 may include gel or silicone padding for added comfort.

[0047] As depicted in Figure 3, the collar 210 includes a first collar segment 212 and a second collar segment 214, which are configured to enclose and support opposing sides of the leg. These segments 212, 214 are coupled via one or more hinges or flexible joints and may be secured together using adjustable fastening elements such as straps, buckles, or hook-and-loop closures.

[0048] The collar 210 further includes an upper portion 216 and a lower portion 218. The upper portion 216 is configured to support an upper portion of the leg, while the lower portion 218 supports a lower portion of the leg, thereby helping to distribute the load and enhance fit.

[0049] The rotational band 220 is positioned on the interior surface of the lower portion 218 of the collar 210. The band 220 is configured to allow controlled rotational movement of the limb segment in the transverse plane, thereby helping to enable pivoting motion about the longitudinal axis of the lower leg. This movement supports a more natural gait and improved functional mobility.

[0050] The tensioner 230 is operably connected to one or both of the first and second collar segments 212, 214. When actuated, the tensioner 230 draws the segments 212, 214 together to conform the collar 210 snugly around a user’s leg. The ratcheting dial 232 adjusts the tension in the cable 234, which may be routed through internal guide channels 236 or secured via anchor points 238 along the exterior of the collar 210. This configuration provides a customizable and secure fit that can be finely adjusted for both comfort and stability, without removing the device.Strut

[0051] As noted above, the brace 100 includes the strut 400 mechanically coupling the leg cuff 200 to the footplate 1100. Figures 4-11 illustrate examples of the strut 400. The brace 100 can include any example of the strut 400 described below.

[0052] Figures 4A and 4B illustrate examples of a simplified strut 400A and 400B. In particular, Figure 4A illustrates a simplified example of a three-member strut, and Figure 4B illustrates a simplified example of a five-member strut.

[0053] Referring to Figure 4A, the strut 400A includes three members: a first member 402A having a first end 404 A and a second end 406 A opposite the first end 404 A; a second member 412A having a first end 414A and a second end 416A opposite the first end 414A; and a third member 422A having a first end 424A and a second end 426A opposite the first end 424A.The first member 402 A extends between the second member 412A and the third member 422 A, with the first end 414A of the second member 412A coupled to the first end 404 A of the first member 402A, and the first end 424A of the third member 422A coupled to the second end 406A of the first member 402A.

[0054] In other words, the second member extends along a length of the first member 402A starting from the first end 404A and extending to a medial portion 408A of the first member 402A, while the third member 422A extends along the length of the first member 402A starting from the second end 406A and extending to the medial portion 408A of the first member 404 A. Thus, the second ends 416A and 426 A of both the second member 412A and third member 422A remain free and are not fixedly coupled to the first member 402A. Instead, respective adjustable coupling elements 440A and 450A are configured to be moveable along the length of the first member 402A, allowing for selective positioning and mechanically coupling a remainder portion of the second member 412A and a remainder portion of the third member 422A to the first member 402A.

[0055] In some examples, as is described further below, respective clamps may be used to couple the first end 414A of the second element 412A and the first end 424 A of the third element 422 A to the first element 402A. However, any other coupling device or fastening members may be used to couple the first end 414A of the second member 412A to the first end 404 A of the first member 402A and the first end 424A of the third member 422A to the second end 406A of the first member 402A.

[0056] In some examples, as illustrated in Figure 4A, the first member 402A may have a length that is greater than a length of the second member 412A and a length of the third member 422A. In some examples, the length of the first member 402A is sufficient to accommodate both the length of the second member 412A and the length of the third member 422 A. In yet some examples, the second member 412A and the third member 422 A may have the same or similar lengths. In yet further some examples, the length of each of the second member 412A and the third member 422A is equal to or less than half the length of the first member 402A.

[0057] Furthermore, each of the first member 402A, second member 412A, and third member 422A may be made from metals (e.g., aluminum, stainless steel, titanium), thermoplastics (e.g., polycarbonate, ABS, nylon), carbon fiber composites, or combinations thereof.

[0058] Yet further, each of the first member 402 A, second member 412A, and the third member 422 A may be different in thickness. In one example, a thickness of the second member 412A and a thickness of the third member 422A are equal to one another, and / or a thickness of the first member 402A is different than the thickness of the second member 412A and thethickness of the third member 422A. In one such example, a thickness of the first member 402A is less than a thickness of the second member 412A and a thickness of the third member 422 A. In another example, each of the first member 402 A, second member 412A, and the third member 422A have the same thickness.

[0059] As previously noted, the strut 400A includes the first adjustable coupling element 440A and the second adjustable coupling element 450A. The first adjustable coupling element 440A is configured to mechanically couple a remaining free portion of the second member 412A to the first member 402A, while the second adjustable coupling element 450A is configured to mechanically couple the remaining free portion of the third member 422A to the first member 402A.

[0060] In some examples, as is described below, the first adjustable coupling element 440A and the second adjustable coupling element 450A may be rings configured to slidably move along each respective second member 412A coupled to the first member 402 A and third member 422A coupled to the first member 402A. However, any adjustable coupling element may be used and the present disclosure is not limited to a ring.

[0061] Each coupling element is adjustably positionable along the length of the first member 402A. Once positioned at a desired location, the respective adjustable coupling element 440A or 450A is configured to be secured in place to mechanically couple the corresponding member (i.e., second member 412A or third member 422A) to the first member 402A.

[0062] This adjustability allows connection points where the respective adjustable coupling elements 440A, 450A are positioned to be selectively repositioned along the length of the first member 402A to address desired application needs. By changing the location of the connection points via the adjustable coupling elements 440A, 450A, the effective geometry of the strut 400A can be altered, thereby helping to modify the mechanical properties of the strut 400A — such as its stiffness, flexibility, and overall bending behavior.

[0063] In other words, the stiffness of the strut 400A and / or the effective bending location (e.g., medial point X) of the strut 400A is controlled by moving at least one of the first adjustable coupling element 440A or the second adjustable coupling element 450A to change a position of an effective bending location between the first adjustable coupling element 440A and the second adjustable coupling element 450A, and as a result also adjusting the biomechanics of the an ankle of a user.

[0064] For example, Figures 5A-5D illustrate some of the mechanical properties of the strut 400A based on the location of the connection points via the adjustable coupling elements 440A and 450A.

[0065] For example, as depicted in Figure 5A, the first adjustable coupling element 440A and the second adjustable coupling element 450A are positioned toward the medial portion 408A of the first member 402 A (i.e., the second end 416A of the second member 412A and the second end 426A of the third member 422A), thereby providing a high degree of stiffness in the strut 400A.

[0066] As depicted in Figure 5B, the first adjustable coupling element 440A is positioned away from the medial portion 408 A (i.e., toward the first end 414A of the second member 412A and the first end 404A of the first member 402A), and the second adjustable coupling element 450A is positioned away from the medial portion 408A (i.e., toward the first end 424A of the third member 422A and the second end 406A of the first member 402A. In other words, both the first adjustable coupling element 440A and the second adjustable coupling element 450A are positioned away from the medial portion 408A of the first member 402A. As a result, the strut 400A provides a low degree of stiffness.

[0067] As depicted in Figure 5C, the first adjustable coupling element 440A is positioned away from the medial portion 408 A (i.e., toward the first end 414A of the second member 412A and the first end 404A of the first member 402A), while the second adjustable coupling element 450A is positioned toward the medial portion 408A of the first member 402A (i.e., the second end 426A of the third member 422A). As a result, a center of bending (e.g., medial point X) of the strut 400A is located toward an upper portion or upper region of the strut 400A.

[0068] As depicted in Figure 5D, the first adjustable coupling element 440A is positioned toward the medial portion 108A (i.e., the second end 416A of the second member 412A), while the second adjustable coupling element 450A is positioned away from the medial portion 108 A (i.e., toward the first end 424A of the third member 422A and the second end 406A of the first member 202A). As a result, a center of bending (e.g., medial point) of the strut 400A is located toward a lower portion or lower region of the strut 400A.

[0069] Furthermore, the strut 400A may be adjusted such that a stiffness of the strut 400A in a forefoot direction is lower than the stiffness of the strut 400A in a rearfoot direction.

[0070] Referring back to Figures 4A and 4B, in some examples, the strut 400 may include five members, as illustrated in Figure 4B. In such an example, one or more components of the strut 400B are the same or similar in form and function to one or more components of the strut 400A.

[0071] For example, strut 400B includes five members instead of three members are described above with reference to strut 400A. Strut 400B includes: a first member 402B having a first end 404B and an opposite second end 406B; a second member 412B having a first end 414B andan opposite second end 416B; a third member 422B having a first end 424B and an opposite second end 426B; a fourth member 462B having a first end 464B and an opposite second end 466B; and a fifth member 472B having a first end 474B and an opposite second end 476B.

[0072] Similar to strut 400 A, the second member 412B extends along one side of the first member 402B from the first end 404B toward a medial portion 408B, while the third member 422B extends along the same side of the first member 402B from the second end 406B toward the medial portion 408B.

[0073] The fourth member 462B and fifth member 472B are positioned on the opposite side of the first member 402B, with the fourth member 462B opposing the second member 412B and the fifth member 472B opposing the third member 422B. In other words, the first member 402B is positioned between the second member 412B and the third member 422B on one side, and the fourth member 462B and the fifth member 472B on the opposite side.

[0074] Similar to strut 400A, 400B includes adjustable coupling elements 440B and 450B that are configured to mechanically couple a remaining free portion of the second member 412B and the fourth member 462B to the first member 402B, while the second adjustable coupling element 450B is configured to mechanically couple the remaining free portion of the third member 422B and the fifth member 472B to the first member 402B.

[0075] As depicted in Figure 4B, the first and second adjustable coupling elements 440B and 450B may be implemented as rings configured to encircle respective members 402B, 412B, 422B, 462B, and 472B. The first and second adjustable coupling elements 440B and 450B allow for adjustable positioning along the length of the first member 402B. However, any adjustable coupling element may be used, and the present disclosure is not limited to a ring.

[0076] Furthermore, similar to strut 400A, each coupling element 440B and 450B is adjustably positionable along the length of the first member 402B. Once positioned at a desired location, the respective adjustable coupling element 440B or 450B is configured to be secured in place to mechanically couple the corresponding member (i.e., second member 412b and fourth member 462B, or third member 422B and fifth member 472B) to the first member 402B.

[0077] Similar to strut 400A, by changing the connection locations via the adjustable coupling elements 440B and 450B, the effective geometry of the strut 400B can be altered, thereby modifying the mechanical properties of the strut 400B — such as its stiffness, flexibility, and overall bending behavior.

[0078] In this example, the extra strut members 462B and 472B provide improved structural stability and load distribution across the strut 400B. By positioning the first member 402B betweensymmetrically opposed pairs of members (i.e., 412B, 422B, 462B, and 472B), the strut 400B can provide higher levels of stiffness.

[0079] Figures 6A and 6B illustrate another example of the strut 400. In particular, Figures 6A illustrates a perspective view of a first example of a manually adjustable strut 600 and Figure 6B illustrates an exploded view of the manually adjustable strut 600 shown in Figure 6A.

[0080] In this example, one or more components of strut 600A are the same as, or similar in form and function to, corresponding components of strut 400A. Notably, strut 600A includes the same three-member configuration as strut 400A. However, in other example examples, strut 600 A may alternatively include a five-member configuration similar to that of strut 400B.

[0081] Similar to strut 400A of Figure 4A, in the example shown in Figures 6A and 6B, the strut 600 includes three members: a first member 602 having a first end 604 and a second end 606 opposite the first end 604; a second member 612 having a first end 614 and a second end 616 opposite the first end 614; and a third member 622 having a first end 624 and a second end 626 opposite the first end 624. The first member 602 extends between the second member 612 and the third member 622, with the first end 614 of the second member 612 coupled to the first end 604 of the first member 602, and the first end 624 of the third member 622 coupled to the second end 606 of the first member 602.

[0082] As depicted in Figures 6A and 6B, the second member 612 extends along the length of the first member 602 from the first end 604 toward a medial portion 608 of the first member. Similarly, the third member 622 extends from the second end 606 toward the same medial portion 608. A central gap 605 between the second and third members 612, 622 exposes the intermediate portion of the first member 602. In other words, the second member 612 is aligned with a first portion 601 of the first member 602 and the third member 622 is aligned with a second portion 603 of the first member 602.

[0083] As mentioned above, the second member 612 and the third member 622 may have the same or similar lengths. In some examples, the length of each of the second member 612 and the third member 622 is equal to or less than half the length of the first member 602. This proportional sizing allows both the second and third members 612, 622 to extend from opposite ends of the first member 602 toward the medial portion 608 of the first member 602 without overlapping, thereby creating a central gap 605 that exposes the intermediate portion of the first member 602. This configuration facilitates independent adjustability of the coupling elements and supports modular control over the mechanical properties of the strut 600.

[0084] To fixedly couple the second member 612 and the third member 622 to the first member 602, the strut 600 includes a pair of clamps 680. A first clamp 681 of the pair of clamps 680 is configured to fixedly couple the first end 614 of the second member 612 to the first end 604 of the first member 602, and the second clamp 683 of the pair of clamps 680 is configured to couple the first end 624 of the third member 622 to the second end 606 of the first member 602. Each clamp 681, 683 includes an outer clamp component 682 and an adapter clamp 684. The adapter clamp 684 is configured to be coupled to either of the leg cuff 200 or the footplate 1100.

[0085] Additionally, each clamp 681, 683 includes a fastening member 686 configured to be received through a corresponding hole in the outer clamp component 682, a corresponding hole in the second member 612 or third member 622, a corresponding hole in the first member 602, and a corresponding hole in the opposing adapter clamp 684. The fastening member 686 may comprise a bolt, pin, or other mechanical fastener, and is configured to apply a compressive force across the assembly, thereby coupling the members in place.

[0086] The second ends 616 and 626 of the second and third members remain free and are not permanently fixed to the first member 602. Instead, these remaining portions are mechanically coupled via adjustable coupling elements 640 and 650. In other words, the first adjustable coupling element 640 and the second adjustable coupling element 650 are configured to mechanically couple the remaining free portion of the second member 612 to the first member 602, while the second adjustable coupling element 650 is configured to mechanically couple the remaining free portion of the third member 622 to the first member 602.

[0087] In this example, the first adjustable coupling element 640 includes a first ring 642 and a first fastening member 644, while the second adjustable coupling element 650 includes a second ring 652 and a second fastening member 654. The rings 642 and 652 are configured to encircle the respective sections of the second member 612 and third member 622, as well as the first member 602.

[0088] The rings 642 and 652 are slidable along the length of the first member 602, enabling manual repositioning of the coupling points. For example, the by adjusting the position of the rings 642 and 652 along the length of the first member 602, a user can modify the stiffness of the strut 600 and / or shift the location of the strut's center of bending to suit specific performance requirements.

[0089] To secure the adjustable coupling elements 640 and 650 at desired locations, the second member 612 and third member 622 each include corresponding coupling sections withmultiple holes. For example: a section 618 of the second member 612, and a section 628 of the third member 622 contain a plurality of holes configured to be received by the respective fastening member 644, 654 of either the first adjustable coupling element 640 or the second adjustable coupling element 650.

[0090] Therefore, the fastening members 686 of respective adjustable coupling elements 640, 650 may be selectively inserted through these aligned holes, providing secure, repeatable attachment points. This hole-based adjustability enhances the mechanical adjustability of the strut 600, including its stiffness, load-bearing behavior, and deformation response.

[0091] For example, to adjust the stiffness, load-bearing characteristics, and deformation response of the strut 600, the position of at least one of the coupling elements 640 or 650 can be manually adjusted. Moving either the first adjustable coupling element 640 or the second adjustable coupling element 650 changes the length of the section of the second member 612 and / or the third member 622 that engages with the first member 602. This adjustment directly alters the stiffness of the strut and the location of the center of bending the strut 600 as explained above with reference to Figures 5A-5D.

[0092] Figures 7A and 7B illustrate another example of the strut 600. In particular, Figure 7A illustrates a perspective view of a second example of a manually adjustable strut 700 and Figure 7B illustrates an exploded view of the manually adjustable strut 700 shown in Figure 7A.

[0093] In this example, one or more components of strut 700 are the same as, or similar in form and function to, corresponding components of strut 600. Notably, strut 700 includes the same three-member configuration as example strut 600, but also includes a knob and gear assembly configured to move the first adjustable coupling element and the second adjustable coupling element along a length of the strut 700.

[0094] Similar to strut 600 of Figures 6A and 6B, the strut 700 includes three members: a first member 702 having a first end 704 and a second end 706 opposite the first end 704; a second member 712 having a first end 714 and a second end 716 opposite the first end 714; and a third member 722 having a first end 724 and a second end 726 opposite the first end 724. The first member 702 extends between the second member 712 and the third member 722, with the first end 714 of the second member 712 coupled to the first end 704 of the first member 702, and the first end 724 of the third member 722 coupled to the second end 706 of the first member 702.

[0095] The second member 712 extends along the length of the first member 702 from the first end 704 toward a medial portion 708 of the first member 702. Similarly, the third member 722extends from the second end 706 toward the same medial portion 708. A central gap 705 between the second member 712 and the third member 722 exposes the intermediate portion of the first member 702.

[0096] To fixedly couple the second member 712 and the third member 722 to the first member 702, the strut 700 includes a pair of clamps 780. A first clamp 781 of the pair of clamps 780 is configured to fixedly couple the first end 714 of the second member 712 to the first end 704 of the first member 702, and the second clamp 783 of the pair of clamps 780 is configured to couple the first end 724 of the third member 722 to the second end 706 of the first member 702. Each clamp 781, 783 includes an outer clamp component 782 and an adapter clamp 784. The adapter clamp 784 is configured to be coupled to either of the leg cuff 200 or the footplate 1100.

[0097] A fastening member 786 is configured to be received through a corresponding hole in the outer clamp component 782, a corresponding hole in the second member 712 or third member 722, a corresponding hole in the first member 702, and a corresponding hole in the adapter clamp 784.

[0098] The second ends 716 and 726 of the second member 712 and third member 722, respectively, remain free and are not permanently fixed to the first member 702. Instead, these remaining portions are mechanically coupled to the first member 702 using adjustable coupling elements 740 and 750. Specifically, the first adjustable coupling element 740 is configured to mechanically couple the free portion of the second member 712 to the first member 702, while the second adjustable coupling element 750 is configured to couple the free portion of the third member 722 to the first member 702.

[0099] In this example, the first adjustable coupling element 740 includes a first ring 742 and the second adjustable coupling element 750 includes a second ring 752. Each ring 742, 752 is configured to encircle a respective engaged section of the second member 712 or third member 722, along with the first member 702. The rings 742, 752 are slidable along the length of the first member 702, allowing for repositioning of the coupling points based on user needs.

[0100] To enable precise manual adjustment, the strut 700 further includes a first gear assembly 760, a first knob 762, a second gear assembly 770, and a second knob 772. The first gear assembly 760 is operatively connected to the first knob 762 and the adjustable coupling element 740, and the second gear assembly 770 is operatively connected to the second knob 772 and the second adjustable coupling element 750. Each gear assembly 760, 770 is configured toconvert rotational input from corresponding knobs 762, 772 into linear displacement of the respective adjustable coupling elements 740, 750 along the first member 702.

[0101] The first gear assembly 760 and the second gear assembly 770 may each include one or more mechanical components such as lead screws, worm gears, rack-and-pinion systems, or other gear mechanisms. These components are configured to provide smooth and controlled movement of the adjustable coupling elements 740 and 750 with minimal effort. As the knobs 762 and 772 are actuated (e.g., rotated), the respective gear assemblies, 760, 770 engage to slide the respective coupling elements 740, 750 along the first member 702, helping to fine-tune adjustments to the engaged lengths of the second member 712 and third member 722, and enabling precise control over the stiffness and bending characteristics of the strut 700.

[0102] In this example, the first gear assembly 760 and the second gear assembly 770 each include a rack and pinion mechanism. For example, the first gear assembly 760 includes a rack 764 and a pinion gear 766, while the second gear assembly 770 includes a rack 774 and a pinion gear 776. In each assembly, the rack 764, 774 is a linear component (e.g., a bar or threaded rod) having one end operatively coupled to a corresponding adjustable coupling element 740 or 750, and the other fixedly coupled to a corresponding clamp 780 (e.g., outer clamp component 782) near the knob 762 or 772. The pinion gear 766, 776 is coupled to the corresponding knob 762, 772 such that actuation of the knob 762, 772 rotates the respective pinion gear 766, 776.

[0103] As a result, as a user turns the knob 762 or 772, the rotational motion is transferred to the pinion gear 766 or 776. The teeth of the pinion gear engage with the corresponding rack 764 or 774, translating the rotational movement into linear displacement of the rack. Since the rack is mechanically coupled to the adjustable coupling element 740 or 750, this motion slides the coupling element 740, 750 along the length of the first member 702.

[0104] In some examples, as described below with reference to Figure 9, the knobs 762 and 772 may be operatively coupled to one or more motors such that rotational input can be provided electronically rather than manually.

[0105] Figures 8A and 8B illustrate another example of the strut 600. In particular, Figure 8A illustrates a perspective view of a third example of a manually adjustable strut 800 and Figure 8B illustrates an exploded view of the manually adjustable strut 800 shown in Figure 8A.

[0106] In this example, one or more components of strut 800 are the same as, or similar in form and function to, corresponding components of strut 600. Notably, strut 800 includes the same three-member configuration as example strut 600, but also includes a knob and gear assemblyconfigured to move both the first adjustable coupling element and the second adjustable coupling element simultaneously along a length of the strut 800.

[0107] Similar to strut 600 of Figures 6A and 6B, the strut 800 includes three members: a first member 802 having a first end 804 and a second end 806 opposite the first end 804; a second member 812 having a first end 814 and a second end 816 opposite the first end 814; and a third member 822 having a first end 824 and a second end 826 opposite the first end 824. The first member 802 extends between the second member 812 and the third member 822, with the first end 814 of the second member 812 coupled to the first end 804 of the first member 802, and the first end 824 of the third member 822 coupled to the second end 806 of the first member 802.

[0108] The second member 812 extends along the length of the first member 802 from the first end 804 toward a medial portion 808 of the first member 802. Similarly, the third member 822 extends from the second end 806 toward the same medial portion 808. A central gap 805 between the second member 812 and the third member 822 exposes the intermediate portion of the first member 802.

[0109] To fixedly couple the second member 812 and the third member 822 to the first member 802, the strut 800 includes a pair of clamps 880. A first clamp 881 of the pair of clamps 880 is configured to fixedly couple the first end 814 of the second member 812 to the first end 804 of the first member 802, and the second clamp 883 of the pair of clamps 880 is configured to couple the first end 824 of the third member 822 to the second end 806 of the first member 802. Each clamp 881, 883 includes an outer clamp component 882 and an adapter clamp 884. The adapter clamp 884 is configured to be coupled to either of the leg cuff 200 or the footplate 1100.

[0110] A fastening member 886 is configured to be received through a corresponding hole in the outer clamp component 882, a corresponding hole in the second member 812 or third member 822, a corresponding hole in the first member 802, and a corresponding hole in the adapter clamp 884.[Oi l 1] The second ends 816 and 826 of the second member 812 and third member 822, respectively, remain free and are not permanently fixed to the first member 802. Instead, these remaining portions are mechanically coupled to the first member 802 using adjustable coupling elements 840 and 850. Specifically, the first adjustable coupling element 840 is configured to mechanically couple the free portion of the second member 812 to the first member 802, while the second adjustable coupling element 850 is configured to couple the free portion of the third member 822 to the first member 802.

[0112] In this example, the first adjustable coupling element 840 includes a first ring 842 and the second adjustable coupling element 850 includes a second ring 852. Each ring 842, 852 is configured to encircle a respective engaged section of the second member 812 or third member 822, along with the first member 802. The rings 842, 852 are slidable along the length of the first member 802, allowing for repositioning of the coupling points based on a user needs.

[0113] As depicted in Figures 8A and 8B, the strut 800 includes a first gear assembly 860, a second gear assembly 870, a rack (e.g., coupling) 871, and a knob 872. The first gear assembly 860 is operatively connected to the adjustable coupling element 840 and the first clamp 881, and the second gear assembly 870 is operatively connected to the knob 872, the second adjustable coupling element 850, and the second clamp 883. The rack 871 is operatively coupled to both the first gear assembly 860 and the second gear assembly 870, enabling coordinated interaction between them.

[0114] The first gear assembly 860 and the second gear assembly 870 may each include one or more mechanical components such as lead screws, worm gears, rack-and-pinion systems, or other gear mechanisms. These components are configured to provide smooth and controlled movement of the adjustable coupling elements 840 and 850 with minimal effort.

[0115] In this example, the first gear assembly 860 and the second gear assembly 870 each include a rack and pinion mechanism. For example, the first gear assembly 860 includes a rack 864 and a pinion gear 866, while the second gear assembly 870 includes a rack 874 and a pinion gear 876. In each assembly 860, 870, the rack 864, 874 is a linear component (e.g., a bar or threaded rod) having one end operatively coupled to a corresponding adjustable coupling element 840 or 850, and the other fixedly coupled to a corresponding clamp 880 (e.g., outer clamp component 882). Thus, when the knob 872 is rotated, the second gear assembly 870 drives the rack 871, which in turn transmits motion to the first gear assembly 860. The corresponding pinion gears 866, 876 engage their respective racks 864, 874, converting the rotational input into linear displacement. As a result, the adjustable coupling elements 840, 850 are simultaneously translated along the length of the first member 802, enabling precise and synchronized positioning of the adjustable clamping elements 840, 850.

[0116] For example, rotating the knob 872 in one direction moves the coupling elements 840 and 850 toward each other in tandem; rotating the knob 872 in the opposite direction moves the coupling elements 840, 850 apart from each other in tandem. This configuration allows a user to fine-tune the engaged lengths of the second member 812 and third member 822, enablingprecise control over the stiffness and bending characteristics of the strut 800 with minimal effort.

[0117] In some examples, as described below with reference to Figure 11, the knob 872 may be operatively coupled to a motor such that rotational input can be provided electronically rather than manually.

[0118] Figures 9A and 9B illustrate another example of the strut 700. In particular, Figure 9A illustrates a perspective view of a first example of a motorized adjustable strut 900 and Figure 9B illustrates an exploded view of the motorized adjustable strut 900 shown in Figure 9A.

[0119] In this example, one or more components of strut 900 are the same as, or similar in form and function to, corresponding components of strut 700. Notably, strut 900 maintains the same three-member configuration as the example strut 700, but further includes at least one motor operatively coupled to at least one gear assembly. The motor is configured to automate the adjustment of one or more coupling elements, thereby enabling powered or semi-automated control of strut stiffness or bending location of the strut 900.

[0120] Referring to Figures 9A and 9B, the strut 900 includes a first member 902 having a first end 904, a second end 906, and a medial portion 908. The strut 900 also includes a second member 912 that is coupled at a first end 914 to the first end 904 of the first member 902, and a third member 922 that is coupled at a first end 924 to the second end 906 of the first member 902. Both the second member 912 and the third member 922 extend toward the medial portion 908 of the first member 902, leaving a central gap 905 between the two members 912, 922, and allowing the second ends 916 and 926, respectively, to remain free.

[0121] Similar to strut 700, the second ends 916 and 926 are adjustably coupled to the first member 902 via a first adjustable coupling element 940 and a second adjustable coupling element 950. The first adjustable coupling element 940 includes a first ring 942 that encircles the second member 912 and the first member 902, while the second adjustable coupling element 950 includes a second ring 952 that encircles the third member 922 and the first member 902. Each ring is slidable along the length of the first member 902 to allow repositioning of the coupling points.

[0122] The first ends 914 and 924 of the second and third members are fixed to the first member 902 using a pair of clamps 980. A first clamp 981 secures the second member 912 using an outer clamp component 982 and an adapter clamp 984, while a second clamp 983 similarly secures the third member 922.

[0123] A fastening member 986 passes through aligned holes in the clamps 981, 983 and the members 902, 912, 922 to secure the members together.

[0124] Similar to strut 700, to enable precise movement of the adjustable coupling elements 940 and 950, the strut 900 further includes a first gear assembly 960 and second gear assembly 970. However, unlike strut 700, the first gear assembly 960 is operatively connected to a first motor 990 and includes a rack 964 and pinion gear 966; the second gear assembly 970 is connected to a second motor 992 and includes a rack 974 and pinion gear 976. Each gear assembly 960, 970 converts rotational input from the corresponding motors 990, 992 into linear movement of the respective adjustable coupling element, enabling fine control over the stiffness and bending characteristics of the strut.

[0125] In some examples, the motor 990, 992 may be actuated via a button, however, in other examples, the motor 990, 992 may be controlled via a controller.

[0126] Figures 10A and 10B illustrate another example of the strut 800. In particular, Figure 10A illustrates a perspective view of a second example of a motorized adjustable strut 1000 and Figure 10B illustrates an exploded view of the motorized adjustable strut 1000 shown in Figure 10 A.

[0127] In this example, one or more components of strut 1000 are the same as, or similar in form and function to, corresponding components of strut 800. Notably, strut 1000 maintains the same three-member configuration as the example strut 800, but further includes at least one motor operatively coupled to at least one gear assembly. The motor is configured to automate the adjustment of one or more coupling elements, thereby enabling powered or semi-automated control of strut stiffness or bending location of the strut 1000.

[0128] Referring to Figures 10A and 10B, the strut 1000 includes a first member 1002 having a first end 1004, a second end 1006, and a medial portion 1008. The strut 1000 also includes a second member 1012 that is coupled at a first end 1014 to the first end 1004 of the first member 1002, and a third member 1022 that is coupled at a first end 1024 to the second end 1006 of the first member 1002. Both the second member 1012 and the third member 1022 extend toward the medial portion 1008 of the first member 1002, leaving a central gap 1005 between the two members 1012, 1022, and allowing the second ends 1016 and 1026, respectively, to remain free.

[0129] Similar to strut 800, the second ends 1016 and 1026 are adjustably coupled to the first member 1002 via a first adjustable coupling element 1040 and a second adjustable coupling element 1050. The first adjustable coupling element 1040 includes a first ring 1042 that encircles the second member 1012 and the first member 1002, while the second adjustable coupling element 1050 includes a second ring 1052 that encircles the third member 1022 andthe first member 1002. Each ring is slidable along the length of the first member 1002 to allow repositioning of the coupling points.

[0130] The first ends 1014 and 1024 of the second and third members are fixed to the first member 1002 using a pair of clamps 1080. A first clamp 1081 secures the second member 1012 using an outer clamp component 1082 and an adapter clamp 1084, while a second clamp 1083 similarly secures the third member 1022.

[0131] A fastening member 1086 passes through aligned holes in the clamps 1081, 1083 and the members 1002, 1012, 1022 to secure the members together.

[0132] Similar to strut 800, to enable precise movement of the adjustable coupling elements 1040 and 1050, the strut 1000 further includes a first gear assembly 1060, a second gear assembly 1070, a shared rack (e.g., coupling) 1071, and a motor 1090. The first gear assembly 1060 is operatively connected to the first adjustable coupling element 1040 and the first clamp 1080, while the second gear assembly 1070 is operatively connected to the second adjustable coupling element 1050, the second clamp 1083, and the motor 1090. The shared rack 1071 links both gear assemblies 1060 and 1070, allowing coordinated operation.

[0133] Each gear assembly 1060, 1070 may include mechanical components such as lead screws, worm gears, or rack-and-pinion systems configured to provide smooth and controlled movement of the adjustable coupling elements 1040, 1050 with minimal user effort.

[0134] In this example, both gear assemblies 1060, 1070 use rack-and-pinion mechanisms. The first gear assembly 1060 includes a rack 1064 and pinion gear 1066; the second gear assembly 1070 includes a rack 1074 and pinion gear 1076. Each rack 1064, 1074 is a linear element with one end connected to its respective adjustable coupling element 1040 or 1050, and the other end fixed to a corresponding clamp 1080 (e.g., outer clamp component 1082). When the motor 1090 is actuated, the second gear assembly 1070 is actuated, which drives the shared rack 1071. This motion is transferred to the first gear assembly 1060, where the pinion gears 1066 and 1076 engage with their racks 1064, 1074, converting rotational input into linear displacement. As a result, both adjustable coupling elements 1040, 1050 slide along the first member 1002 in tandem, allowing precise and synchronized adjustment.

[0135] In some examples, the motor 1090 may be actuated via a button, however, in other examples, the motor 1090 may be controller via a controller.Footplate

[0136] As noted above, the brace 100 also includes a footplate 1100, examples of which are illustrated in Figures 11 A and 1 IB.

[0137] Referring to Figures 11 A and 1 IB, the footplate 1100 is configured to provide structural support to a user’s foot while enabling controlled rotation in the frontal plane (e.g., inversion and eversion). The footplate 1100 is also configured to fit inside a user’s footwear without requiring any modification (e.g., holes), allowing the brace 100 to be worn with standard footwear.

[0138] The footplate 1100 includes a base plate 1102 for receiving the foot, a hinge or pivot mechanism 1104 that facilitates angular motion, and a rear structure 1106. The rear structure 1106 is configured to: (1) provide support for the heel to help maintain stability and alignment during movement, and (2) couple the footplate 1100 to the strut 400, as previously described. The footplate includes a front portion 1107 and a rear portion 1108.

[0139] In this example, the footplate 1100 is made from carbon-fiber. However, in other examples, the footplate 1100 may be constructed from alternative materials such as fiberglass, thermoplastics, metals, or composite blends, depending on the desired balance of strength, flexibility, weight, and durability.

[0140] In some examples, the footplate 1100 further includes a hind foot adjustment device 1110, positioned near the rear portion 1108 of the footplate 1100. The hind foot adjustment device 1110 is configured to adjust an angle A between the footplate 1100 and the strut 400, enabling customizable alignment based on user anatomy, rehabilitation needs, or terrain.

[0141] For example, the hind foot adjustment device 1110 includes a spring 1112 positioned between a bottom surface of the base plate 1102 and an interior surface of the hind foot adjustment device 1110. The spring 1112 is configured to provide controlled resistance and support, enabling slight angular displacement of the rear portion 1108 of the footplate 1100 relative to the strut 400. The resistance allows for energy absorption and return during heel strike and push-off phases of gait, which can enhance comfort and dynamic performance.

[0142] In some examples, the spring 1112 may be a coil spring, elastomeric element, or leaf spring, selected based on desired stiffness or user-specific loading profiles. Additionally, the hind foot adjustment device 1110 may include a threaded adjustment mechanism or ratcheting dial (not shown) to fine-tune the preload or angle of the spring 1112, enabling clinicians or users to modify hind foot alignment for conditions such as over pronation, supination, or to accommodate various terrain inclines.

[0143] In some examples, as illustrated in Figure 12, the footplate 1100 may also include a metatarsal rotational element. Referring to Figure 12, the metatarsal rotational element 1120 is positioned near the front portion 1107 of the footplate 1100, (i.e., near the ball of the foot), particularly where the metatarsal bones begin of a user. The metatarsal rotation element 1120is configured to enable the phalanges of a user to rotate or pivot about an axis perpendicular to the sagittal plane. As such, this anatomical location is a natural pivot point used during walking, running, or other dynamic movements, making it critical for restoring biomechanical function.

[0144] The metatarsal rotational element 1120 is operably coupled to the footplate 1100 via a pivot or hinge mechanism 1122, such as a ball-and-socket joint or pin-and-bushing system, enabling controlled rotation in the transverse plane.

[0145] In yet some other examples, the footplate 1100 may include a transverse plane rotational element and a medial-lateral rotation element, as is described in detail below.

[0146] Figures 13A and 13B illustrate another example of a footplate 1300. In particular, Figure 13A illustrates a transverse plane rotational element 1330 of footplate 1300 and Figure 13B illustrates a medial-lateral rotational element 1340 of the footplate 1300.

[0147] In this example, one or more components of footplate 1300 are the same as, or similar in form and function to, corresponding components of the footplate 1100.

[0148] Referring to Figures 13A and 13B, the footplate 1300 includes the base plate 1302 and a rear structure 1306. The base plate 1302 is coupled to the rear structure 1306. The rear structure 1306 is configured to: (1) provide support for the heel of the foot to help maintain stability and alignment during movement, and (2) couple the footplate 1300 to the strut 400, as previously described. The footplate 1300 includes a front portion 1307 and a rear portion 1308. A noted above, the footplate 1300 also includes the transverse plane rotational element 1330 and the medial-lateral rotational element 1340.

[0149] As depicted in Figure 13A, the transverse plane rotational element 1330 is positioned near a heel 1309 of the footplate 1300. The transverse plane rotational element 1330 is configured to control rotational freedom in the transverse plane, helping to enable the base plate 1302 of the footplate 1300 to rotate about a vertical axis VI. In this example, the transverse plane rotational element 1330 is a pivot joint.

[0150] In some examples, the transverse plane rotational element 1330 may be a pivot joint, ball bearing, or spring-loaded mechanism that allows a user’s foot to rotate within a set range of motion.

[0151] Referring to Figure 13B, the footplate 1300 includes the medial-lateral rotational element 1340 configured to control side-to-side movement. The medial -lateral rotational element 1340 is a hinge or pivot point at a connection point between the strut 400 and the rear structure 1306 of the footplate 1300. The medial-lateral rotational element 1340 allows rotation in the frontal plane.

[0152] Second Orthopedic Brace Implementation

[0153] Figure 14 illustrates a simplified diagram of another example orthopedic brace 1400 configured to support a lower leg of a user while allowing controlled movement of an ankle and foot of a user to help treat lower-limb overuse injuries such as stress fractures, tendinopathy, plantar fasciitis, and the like. The example orthopedic brace 1400 is configured to automatically adjust a stiffness of a strut based on a sensor configured to measure metrics related to ankle bending moment, ankle angle and force.

[0154] Referring to Figure 14, the brace 1400 includes a leg cuff 1420 configured to enable rotation in the transvers plane, a strut 1440, and a footplate 1460 configured to enable rotation in the frontal plane. The strut 1440 is configured to mechanically couple the cuff 1420 to the footplate 1460. The brace 1400 further includes at least one sensor 1470 and a controller 1480. As described further below, the sensor 1470 is positioned on the footplate 1460. The sensor 1470 is operatively coupled to the controller 1480, which is operatively coupled to the strut 1440 and configured to adjust a stiffness of the strut 1440 based on input from the sensor 1470. In use, the brace 1400 is configured to determine, via the controller 1480, a strut stiffness adjustment based on the data from the at least one sensor 1470 and a pre-determined orthosis fit value. In one example, the data from the at least one sensor 1470 may comprise strain data.

[0155] In this example, one or more components of the leg cuff 1420 are the same as, or similar in form and function to, corresponding components of the leg cuff 200 described above, and a duplicative description thereof has been omitted. For simplicity, leg cuff 200 is referenced. As noted above, similar to leg cuff 200, leg cuff 1420 may be configured to enable rotation in a transverse plane. For example, with reference to Figure 3, the collar 210 is configured to surround and support a user’s lower leg, while the band 220 is positioned relative to the collar 210 and is configured to enable rotational movement of the collar 210 — and consequently, the leg — in the transverse plane.

[0156] The strut 1440 is configured to transmit a load between the leg and foot during movement, like walking, running, standing, climbing stairs, or the like. The strut 1440 is configured to automatically adjust a stiffness or a location of a center of bending of the strut 1440 based on the sensor 1470 configured to measure metrics related to ankle bending moment, ankle angle and force. In this example, one or more components of the strut 1440 are the same as, or similar in form and function to, corresponding components of example motorized struts 900 and 1000 described above. However, for simplicity and to avoid redundancy, the motorized strut 1000 is referenced.

[0157] In this example, as is described further below in detail, the controller 1480 is configured to control the strut 1440 by actuating motor 1090, which actuates the second gear assembly 1070, driving the shared rack 1071. This motion is transferred to the first gear assembly 1060, where the pinion gears 1066 and 1076 engage with their racks 1064, 1074, converting rotational input into linear displacement. As a result, both adjustable coupling elements 1040, 1050 slide along the length of the first member 1002, changing the location of the connection points via the adjustable coupling elements 1040 and 1050. As a result, a stiffness or a location of a center of bending of the strut 1440 is changed.

[0158] The footplate 1100 provides structural support to a user's foot and allows rotation in the frontal plane i.e., permits movement like inversion and eversion. In this example one or more components of the footplate 1460 are the same as, or similar in form and function to, corresponding components of example footplate 1100 described above.

[0159] Figure 15 illustrates another example of footplate 1460, which includes the sensor 1470. Referring to Figure 15, the footplate 1460 includes a base plate 1462 for receiving a foot, a hinge or pivot mechanism 1464 that facilitates angular motion, and a rear structure 1466. The footplate 1460 also includes sensor 1470, which is positioned on a surface 1461 of the footplate 1460.

[0160] In other examples, the sensor 1472 may be embedded within the base plate 1462 of the footplate 1460. Embedding the sensor 1472 may help to enhance durability, protect the sensor 1472 from external environmental conditions, and allow for more accurate internal measurements of foot-plate interaction during dynamic movements.

[0161] In this decided example, the sensor 1470 is a strain gage sensor configured to measure deformation or strain in the footplate 1460 during use. The strain gauge sensor may be positioned to detect bending, compression, or torsional forces experienced by the footplate 1460 as a user moves. The output from the strain gauge sensor 1470 can be used by the controller 1480, which is discussed further below, to assess loading conditions and dynamically adjust the stiffness of the strut 1440, enabling a more responsive and adaptive user experience.

[0162] Furthermore, in some implementations, for each measurement channel — such as moment or force — at least one strain gauge 1470 is positioned in the upper half of the footplate 1460, and at least one strain gauge 1470 is positioned in the lower half. In this configuration, the strain gauges 1470 are arranged in a Wheatstone bridge circuit to enhance measurement sensitivity and accuracy. The resulting signals are amplified using a signal conditioner mounted to the footwear.

[0163] In some examples, the sensor 1470 is not limited to a strain gauge and can be implemented using other types of sensors, such as force sensors, pressure sensors, inertial measurement units (IMUs), accelerometers, or gyroscopes.

[0164] Figures 16A-D illustrate a method S1600 of embedding a strain gauge sensor 1470 within the footplate 1460. In this example, the footplate 1460 is made from carbon fiber, however, in other examples, the footplate 1460 may be made from alternative materials such as fiberglass, thermoplastics, metals, or composite blends, depending on the desired balance of strength, flexibility, weight, and durability.

[0165] Referring to Figure 16A, the strain gauge sensor 1470 is affixed to a thin wafer of carbon- fiber composite material 1610. The material 1610 is porous, allowing resin to seep through the wafer during a layup and hold it firmly to layers above and below.

[0166] Referring to Figure 16B, the construction of the footplate 1460 is depicted. As illustrated, multiple layers of carbon fiber material are used, both unidirectional (along a footplate axis) and 45-degree material.

[0167] Referring to Figure 16C, a frame apparatus 1620 is used to hold the strain gauge sensor 1470 while assembling the carbon-fiber composite to ensure layer of the composite are properly aligned and spaced. This ensures that the composite layers are properly aligned and spaced during fabrication.

[0168] Referring to Figure 16D, a dried footplate 1460 is depicted. A standard resin layup process is used to infiltrate the resin into the carbon fiber.

[0169] During clinical use of the brace 1400 a comprehensive examination and review of a patient's medical test data may be first conducted. Based on this evaluation, a physician determines whether the patient has a lower-limb overuse injury that would benefit from brace-assisted management. Once this decision is made, a custom brace may be configured specifically for the patient. This includes fabricating a tailored leg cuff 1420, selecting an appropriate adjustable strut length and stiffness range, and choosing the proper footplate thickness to suit the patient’s anatomy and functional goals. Alternatively, the patient may select a brace from a range of premade sizes.

[0170] During an in-office visit, baseline data are collected using sensors embedded in the brace. The patient performs a series of controlled performance and functionality exercises, allowing a clinical team to gather information on the patient's initial lower-limb condition. This includes data on joint angles, forces, and movement dynamics. Baseline medical imaging, such as ultrasound or other tendon assessment tools, may also be used to further characterize tendon stiffness or structural health at the start of treatment.

[0171] At the same visit, the brace 1400 is fitted to the patient and configured for home use.Adjustable parameters — including, at a minimum, strut stiffness and the location of the bending axis — are fine-tuned to the patient's specific needs. Other variables that may be configured include the metatarsal joint angle, resistance to flexion at the metatarsal joint, the strut-to-footplate angle (which corresponds to the degree of plantarflexion or dorsiflexion), and the wedge angle if applicable. The clinical team may also impose limits on certain parameters; for instance, maximum dorsiflexion may be restricted in patients recovering from Achilles tendinopathy. These individualized settings are recorded, and the patient takes the brace 1400 home, where it is worn regularly. While worn, the brace 1400 continuously collects sensor data to monitor the patient’s activity, performance, and loading conditions.

[0172] The brace 1400 supports rehabilitation and recovery by operating in a variety of modes. As noted above, the controller 1480 is used to adjust a stiffness and a location of a center of bending of the strut 1450 based on input from the sensor 1470. The sensor 1470 measures biomechanical variables such as strain, force, or angle, which reflect the loading conditions and movement dynamics experienced by a user. A signal conditioner may be housed near the strain gauge 1470 and configured to amplify and / or filter any noise from the strain gauge 1470. The data is then used by the controller 1480 to make real-time adjustments, ensuring that the brace responds appropriately to a user’s activity and physiological needs.

[0173] For example, in high-activity training or work mode, the controller 1480 may automatically adjust brace settings in real time to maintain a user’s dorsiflexion angle and tendon force within pre-defined thresholds. Alternatively, the patient may opt to use consistent high- activity settings for a more uniform brace response. These settings can be selected using a workstation 128 (e.g., smart phone, mobile computer, communication device, handheld fob, or the like that interfaces with the brace 1400).

[0174] In off-duty or at-home rehabilitation mode, the brace 1400 adjusts its mechanical response to guide recovery by challenging a user within a safe therapeutic range. For instance, the controller 1480 of the brace 1400 may limit maximum dorsiflexion during the stance phase of walking to protect healing tissue while still helping to encourage gradual progress. The controller 1480 may add resistance to the strut 1440 to deliver low-load mechanical stimuli that helps heal tissue (e.g., tendon, bone) injuries.

[0175] In prescribed exercises mode, the brace 1400 may function as a monitoring device, tracking performance metrics during exercises assigned by the clinician. Meanwhile, in a remote telehealth mode, clinicians may be enabled to monitor patients during virtual appointments. Data from the brace sensor 1470 are transmitted in near real time, allowing providers toobserve patient responses to specific movements and adjust brace settings during the session. This mode improves continuity of care between visits and supports data-informed decisionmaking.

[0176] Patients or practitioners may also retain control over the brace's 1400 behavior. Through the workstation 128 (e.g., a mobile app or fob interface) the patients can override the automatic controller 1480 when desired. The interface includes options for one-step manual adjustments, a return-to-neutral (prescribed) setting, a temporary pause in auto-adjustment (e.g., for one hour), and activity-based presets such as high-intensity training or at-home rehab settings.

[0177] Finally, data collected by the brace 1400 are automatically processed and made available to the clinical team via a network 127 to a remote server 125 and database 123. To execute transmission, a Remote Access File Transfer (RAFT) interface and dedicated data logger connect to the brace 1400 to download and store data from the computing system and execute transmission to the server and database. Instead of the RAFT and dedicated data logger, the computing system 129 may include the transmission capabilities. This streamlined data access allows clinicians to assess progress, make timely adjustments, and enhance treatment outcomes through informed, personalized interventions.

[0178] Figure 17 illustrates an exemplary system 120 of the brace 1400. The depicted operating system 120 includes the brace 1400 as described above, which includes a computing system (e.g., including a data acquisition unit) 129, the workstation 128 (e.g., smart phone, mobile computer, communication device, handheld fob, or the like that interfaces with the brace 1400), a monitoring system 121, and the network 127.

[0179] The monitoring system 121 includes a server 125 and a database 123. The monitoring system 121 may include computer systems and networks of a system operator (e.g., the operator of the brace 1400). The server database 123 may be configured to store information regarding the operating conditions or set points for operating the orthopedic brace 1400.

[0180] The monitoring system 121, the workstation 128, and the orthopedic brace 1400 are coupled with the network 127. The phrase “coupled with” is defined to mean directly connected to or indirectly connected through one or more intermediate components. Such intermediate components may include hardware and / or software-based components. As such, any data collection sensors within the orthopedic brace 1400 may be optionally transmitted via the connected network to the monitoring system 121, or workstation 128 for analysis.

[0181] The optional workstation 128 may be a general-purpose computer including programming specialized for providing input to the server 125 and / or the brace 1400. For example, theworkstation 128 may provide settings for the server 125 and / or the brace 1400. The workstation 128 may include at least a memory, a processor, and a communication interface.

[0182] Figure 18 illustrates an example computing system 129 of the brace 1400 of Figure 17. The computing system 129 includes a memory 274, controller 1480 (i.e., processors), and a communication interface 276. The computing system 129 may be coupled to a database 123 and optionally a workstation 128. The computing system 129 may be used as an input device to control the brace 1400 via the controller 1480. In automatic mode, the controller 1480 receives data from the brace sensors, decides the appropriate brace adjustment, and communicates commands to the brace motors. The communication interface 276 receives data indicative of brace adjustments made via the computing system 129 and / or the workstation 128.

[0183] The controller 1480 may include a general processor, digital signal processor, an application specific integrated circuit (ASIC), field programmable gate array (FPGA), analog circuit, digital circuit, combinations thereof, or other now known or later developed processors. The controller 1480 may be a single device or a combination of devices, such as associated with a network, distributed processing, or cloud computing.

[0184] The memory 274 may be a volatile memory or a non-volatile memory. The memory 274 may include one or more of a read-only memory (ROM), random access memory (RAM), a flash memory, an electronic erasable program read-only memory (EEPROM), or other type of memory. The memory 274 may be removable from the computing system 129, such as a secure digital (SD) memory card.

[0185] The communication interface 276 may include any operable connection. An operable connection may be one in which signals, physical communications, and / or logical communications may be sent and / or received. An operable connection may include a physical interface, an electrical interface, and / or a data interface. The communication interface 276 provides for wireless and / or wired communications in any now known or later developed format.

[0186] The communication interface 276 may also include a graphical user interface (GUI) or communicate information to a GUI. The GUI instructions are stored in the memory 274 and executable by the controller 1480. The GUI may be used for one or more purposes, including to convey and / or receive information about the user, displaying (e.g., outputting) data, displaying notifications, and the like.

[0187] In the above-described examples, the network 127 may include wired networks, wireless networks, or combinations thereof. The wireless network may be a cellular telephonenetwork, an 802.11, 802.16, 802.20, or WiMax network. Further, the network 127 may be a public network, such as the Internet, a private network, such as an intranet, or combinations thereof, and may utilize a variety of networking protocols now available or later developed including, but not limited to TCP / IP based networking protocols.

[0188] While the non-transitory computer-readable medium is described to be a single medium, the term “computer-readable medium” includes a single medium or multiple media, such as a centralized or distributed database, and / or associated caches and servers that store one or more sets of instructions. The term “computer-readable medium” shall also include any medium that is capable of storing, encoding, or carrying a set of instructions for execution by a processor or that cause a computer system to perform any one or more of the methods or operations disclosed herein.

[0189] In a particular non-limiting example, the computer-readable medium may include a solid- state memory such as a memory card or other package that houses one or more non-volatile read-only memories. Further, the computer-readable medium may be a random-access memory or other volatile re-writable memory. Additionally, the computer-readable medium may include a magneto-optical or optical medium, such as a disk or tapes or other storage device to capture carrier wave signals such as a signal communicated over a transmission medium. A digital file attachment to an e-mail or other self-contained information archive or set of archives may be considered a distribution medium that is a tangible storage medium. Accordingly, the disclosure is considered to include any one or more of a computer-readable medium or a distribution medium and other equivalents and successor media, in which data or instructions may be stored.

[0190] In an alternative example, dedicated hardware implementations, such as application specific integrated circuits, programmable logic arrays and other hardware devices, may be constructed to implement one or more of the methods described herein. Applications that may include the apparatus and systems of various examples may broadly include a variety of electronic and computer systems. One or more examples described herein may implement functions using two or more specific interconnected hardware modules or devices with related control and data signals that may be communicated between and through the modules, or as portions of an application-specific integrated circuit. Accordingly, the present system encompasses software, firmware, and hardware implementations.

[0191] Furthermore, in accordance with various examples of the present disclosure, the methods described herein may be implemented by software programs executable by a computer system. Further, in an exemplary, non-limited embodiment, implementations may includedistributed processing, component / object distributed processing, and parallel processing. Alternatively, virtual computer system processing may be constructed to implement one or more of the methods or functionalities as described herein.

[0192] Although the present specification describes components and functions that may be implemented in particular embodiments with reference to particular standards and protocols, the claim scope is not limited to such standards and protocols. For example, standards for Internet and other packet switched network transmission (e.g., TCP / IP, UDP / IP, HTML, HTTP, HTTPS) represent examples of the state of the art. Such standards are periodically superseded by faster or more efficient equivalents having the same functions. Accordingly, replacement standards and protocols having the same or similar functions as those disclosed herein are considered equivalents thereof.

[0193] A computer program (also known as a program, software, software application, script, or code) may be written in any form of programming language, including compiled or interpreted languages, and it may be deployed in any form, including as a standalone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program may be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program may be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.

[0194] The processes and logic flows described in this specification may be performed by one or more programmable processors executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows may also be performed by, and apparatus may also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).

[0195] As used in this application, the term “circuitry” or “circuit” refers to all of the following: (a)hardware-only circuit implementations (such as implementations in only analog and / or digital circuitry) and (b) to combinations of circuits and software (and / or firmware), such as (as applicable): (i) to a combination of processor(s) or (ii) to portions of processor(s) / software (including digital signal processor(s)), software, and memory(ies) that work together to cause an apparatus, such as a mobile phone, to perform various functions) and (c) to circuits, suchas a microprocessor s) or a portion of a microprocessor s), that require software or firmware for operation, even if the software or firmware is not physically present.

[0196] This definition of “circuitry” applies to all uses of this term in this application, including in any claims. As a further example, as used in this application, the term “circuitry” would also cover an implementation of merely a processor (or multiple processors) or portion of a processor and its (or their) accompanying software and / or firmware. The term “circuitry” would also cover, for example and if applicable to the particular claim element, a baseband integrated circuit or applications processor integrated circuit for a mobile phone, a cellular network device, or other network device.

[0197] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and anyone or more processors of any digital computer. A processor may receive instructions and data from a read only memory or a random-access memory or both. Components of a computer include a processor for performing instructions and one or more memory devices for storing instructions and data. The computer may also include or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer may be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio player, a Global Positioning System (GPS) receiver, to name just a few. Computer readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media, and memory devices, including by way of example semiconductor memory devices, e.g., E PROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto optical disks; and CD ROM and DVD-ROM disks. The processor and the memory may be supplemented by, or incorporated in, special purpose logic circuitry.

[0198] To provide for interaction with a user, embodiments of the subject matter described in this specification may be implemented on a device having a display, e.g., a CRT (cathode ray tube), LCD (liquid crystal display), or LED (light emitting diode) monitor, for displaying information to the user and a keyboard and a pointing device, e.g., a mouse or a trackball, by which the user may provide input to the computer. Other kinds of devices may be used to provide for interaction with a user as well; for example, feedback provided to the user may be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user may be received in any form, including acoustic, speech, or tactile input.

[0199] It should be understood that arrangements described herein are for purposes of example only. As such, those skilled in the art should appreciate that other arrangements and other elements (e.g. machines, interfaces, functions, orders, and groupings of functions, etc.) can be used instead, and some elements may be omitted altogether according to the desired results. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location, or other structural elements described as independent structures may be combined.

[0200] While various aspects and embodiments have been disclosed herein, other aspects and embodiments should be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0201] Since many modifications, variations, and changes in detail can be made to the described example, it is intended that all matters in the preceding description and shown in the accompanying figures be interpreted as illustrative and not in a limiting sense. Further, it is intended to be understood that the following clauses (and any combination of the clauses) further describe aspects of the present description.

Claims

ClaimsWe claim:

1. An orthopedic brace comprising: a leg cuff; a footplate; and a strut coupling the leg cuff to the footplate, wherein the strut comprises: a first member having a first end and a second end opposite the first end; a second member having a first end and a second end opposite the first end, wherein the first end of the first member is coupled to the first end of the second member; a third member having a first end and a second end opposite the first end, wherein the second end of the first member is coupled to the first end of the third member; a first adjustable coupling element configured to couple the second member to the first member; and a second adjustable coupling element configured to couple the third member to the first member, wherein a stiffness and / or a bending location of the strut is configured to be adjusted based on a movement of at least one of the first adjustable coupling element or the second adjustable coupling element along a length of the first member.

2. The orthopedic brace of claim 1, wherein the stiffness of the strut is controlled by moving at least one of the first adjustable coupling element or the second adjustable coupling element to change a length of a section of the second member that engages with the first member and / or a length of a section of the third member that engages with the first member.

3. The orthopedic brace of any one of claims 1-2, wherein the bending location of the strut is controlled by moving at least one of the first adjustable coupling element or the second adjustable coupling element to change a position of an effective bending location between the first adjustable coupling element and the second adjustable coupling element.

4. The orthopedic brace of any one of claims 1-3, wherein a gap between the second member and the third member exposes the first member.

5. The orthopedic brace of any one of claims 1-4, wherein the first member, the second member, and the third member are each made of carbon fiber composite material.

6. The orthopedic brace of any one of claims 1-5, wherein the first adjustable coupling element and the second adjustable coupling element are configured to move in tandem along the length of the first member.

7. The orthopedic brace of claim 6, wherein an effective bending location between the first adjustable coupling element and the second adjustable coupling element aligns with an effective bending location of the first member.

8. The orthopedic brace of any one of claims 1-5, wherein the first adjustable coupling element and the second adjustable coupling element are configured to move independent of one another along the length of the first member.

9. The orthopedic brace of any one of claims 1-8, wherein an effective bending location of the strut corresponds to a location between the first adjustable coupling element and the second adjustable coupling element.

10. The orthopedic brace of any one of claims 1-9, wherein a thickness of the first member is less than a thickness of the second member and a thickness of the third member.

11. The orthopedic brace of any one of claims 1-10, wherein a length of the first member is greater than a length of the second member and a length of the third member.

12. The orthopedic brace of any one of claims 1-11, wherein a stiffness of the strut in a forefoot direction a lower than a stiffness of the strut in a rearfoot direction.

13. The orthopedic brace of any one of claims 1-12, wherein the first adjustable coupling element comprises a first ring and the second adjustable coupling element comprises a second ring.

14. The orthopedic brace of claim 13, wherein the first ring includes a first pin configured to be removably positioned at least partially through a first plurality of holes in the first member and a corresponding second plurality of holes in the second member, and wherein the second ring includes a second pin configured to be removably positioned at least partially through the first plurality of holes in the first member and a corresponding third plurality of holes in the third member.

15. The orthopedic brace of any one of claims 1-13, further comprising: a knob; and a gear assembly coupled to the knob, the first adjustable coupling element, and the second adjustable coupling element, wherein a rotation of the knob causes the gear assembly to move the first adjustable coupling element and the second adjustable coupling element along the length of the first member.

16. The orthopedic brace of any one of claims 1-13, further comprising: a first knob coupled to the first adjustable coupling element; a second knob coupled to the second adjustable coupling element; and a gear assembly coupled to the first knob, the second knob, the first adjustable coupling element, and the second adjustable coupling element, wherein the first knob is actuated to manually move the first adjustable coupling element along the length of the first member, and wherein the second knob is actuated to manually move the second adjustable coupling element along the length of the first member.

17. The orthopedic brace of any one of claims 1-13, further comprising: a motor; and a gear assembly coupled to the motor, the first adjustable coupling element, and the second adjustable coupling element, wherein the motor causes the gear assembly to move the first adjustable coupling element and the second adjustable coupling element along the length of the first member.

18. The orthopedic brace of any one of claims 1-13, further comprising:a first motor coupled to the first adjustable coupling element; a second motor coupled to the second adjustable coupling element; and a gear assembly coupled to the first motor, the second motor, the first adjustable coupling element, and the second adjustable coupling element, wherein the first motor causes the first adjustable coupling element to move along the length of the first member, and wherein the second motor causes the second adjustable coupling element to move along the length of the first member.

19. The orthopedic brace of any one of claims 15-18, wherein the gear assembly comprises: at least one of a lead screw or a rack-and-pinion mechanism operatively connected to the first adjustable coupling element and the second adjustable coupling element.

20. The orthopedic brace of any one of claims 1-19, further comprising one or more sensors positioned in the footplate.

21. The orthopedic brace of claim 20, wherein the one or more sensors are embedded within the footplate.

22. The orthopedic brace of any one of claims 20-21, wherein the one or more sensors comprise a first set of strain gauges positioned adjacent a first side of the footplate and a second set of strain gauges positioned adjacent a second side of the footplate.

23. The orthopedic brace of any one of claims 1-22, further comprising: one or more sensors positioned in the footplate; a controller configured to receive a set of signals from the one or more sensors; and a motor configured to move the first adjustable coupling element and the second adjustable coupling element along the length of the first member, wherein the controller is configured to actuate the motor based on, at least in part, received signals from the one or more sensors.

24. The orthopedic brace of any one of claims 1-22, further comprising: one or more sensors positioned in the footplate;a controller configured to receive a set of signals from the one or more sensors; a first motor configured to move the first adjustable coupling element along the length of the first member; and a second motor configured to move the second adjustable coupling element along the length of the first member, wherein the controller is configured to actuate the first motor and / or the second motor based on, at least in part, received signals from the one or more sensors.

25. An orthopedic brace comprising: a leg cuff; a footplate; and a strut mechanically coupling the leg cuff to the footplate, wherein the leg cuff configured to enable rotation in a transverse plane and / or the footplate configured to enable rotation in a frontal plane.

26. The orthopedic brace of claim 25, wherein the leg cuff comprises: a collar configured to surround a leg of a user; and a band positioned relative to the collar and configured to enable rotation of the collar in the transverse plane relative to the band.

27. The orthopedic brace of claim 26, wherein the collar comprises a tensioning mechanism configured to adjust a tension of the collar around the leg of the user, and wherein the tensioning mechanism is configured to apply, maintain and adjust the tension.

28. The orthopedic brace of any one of claims 25-27, wherein the footplate is configured to be positioned inside of a shoe of a user.

29. The orthopedic brace of any one of claims 25-28, wherein the footplate comprises a hind foot adjustment device positioned at a rear of the footplate, the hind foot adjustment device being configured to adjust an angle between the strut and the footplate.

30. The orthopedic brace of any one of claims 25-29, wherein the footplate comprises a metatarsal rotational element positioned at a front of the footplate, the metatarsalrotation element being configured to enable the phalanges of a user to rotate or pivot about an axis perpendicular to the sagittal plane.

31. The orthopedic brace of any one of claims 25-30, wherein the strut is an adjustable strut configured to adjust a stiffness of the strut and a bending location of the strut.

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