A customizable lower extremity exercise device

Abstract

The present invention relates to a customizable lower extremity exercise device (1) designed to provide patients with more effective treatment at a lower cost during the early rehabilitation period for individuals with lower extremity problems (such as post-surgical, post-traumatic, or post-stroke conditions). With this device (1), patients will be able to exercise their ankle, knee, and hip joints at the desired range of motion of joint (ROM) without needing to visit a hospital. Stabilizing the hip joint will also enable more effective knee angles.

Description

[0001] A CUSTOMIZABLE LOWER EXTREMITY EXERCISE DEVICE Technical Field

[0002] The present invention relates to a customizable lower extremity exercise device designed to provide patients with more effective treatment at a lower cost during the early rehabilitation period for individuals with lower extremity problems (such as post-surgical, post-traumatic, or post-stroke conditions).

[0003] State of the Art

[0004] The lower extremities consist of the hip, knee, and ankle joint structures. These lower extremities enable walking, standing, and the fulfillment of basic needs. The hips, knees, and ankle joints are the body’s primary weight-bearing joints and are crucial for enabling athletic activities and maintaining mobility throughout the day. Additionally, for normal walking, all joints involved in movement, particularly the hip, knee, and ankle, must possess a normal joint range of motion and adequate muscle strength.

[0005] Among the most common conditions affecting the lower extremities are hip and knee osteoarthritis, as well as ligament injuries of the knee and ankle. During the rehabilitation process for individuals with lower extremity problems, performing passive, active-assisted, active, and resistance- based joint movements is crucial. Depending on the patient’s medical condition, it is important to perform joint range of motion (ROM) exercises (passive, active-assisted, active, and resistance- based).

[0006] In lower extremity conditions (e.g., hip osteoarthritis, knee osteoarthritis), non- pharmacological interventions such as rehabilitation are an integral part of the general recovery process following surgical procedures and are also necessary to improve clinical outcomes. A systematic review and meta-analysis of physical therapy exercises concluded that these exercises are beneficial inthe short term and provide small to moderate benefits for function, range of motion, and quality of life within 3-4 months following surgery.

[0007] The primary focus of early rehabilitation is to prepare patients for discharge from the hospital as soon as possible after surgery. Since a limited range of motion in the hip, knee, or ankle joints affects functional activities, achieving normal joint range of motion is considered one of the primary indicators.

[0008] Robert Salter introduced the concept of biological Continuous Passive Motion (CPM) in the early 1980s. Coutts et al. were the first to initiate CPM use immediately following total knee arthroplasty surgery. Their rationale was based on Salter’s research and the assumption that CPM enhances collagen tissue healing through improved fiber orientation, prevents cross-linking, and thereby produces better movement restoration.

[0009] Today, the CPM device is used as the first step in rehabilitation following many knee surgeries. It can be adjusted to the desired knee angle. Additionally, there are models that can be adjusted to specific ankle angles.

[0010] However, the models designed so far have some drawbacks. Since it does not stabilize the hip joint, the targeted knee angle cannot be maintained due to the leg shifting toward the hip during movement. Furthermore, it is not very convenient for patients to come to the hospital for rehabilitation during the immediate post-surgical period. There is a need for a device that facilitates monitoring patients at home. The need for devices that enable patients to actively participate in rehabilitation during later stages is also evident.

[0011] In current solutions, the hip, knee, and ankle are not sufficiently stabilized. The degree of joint range of motion in the hip joint cannot be determined. Furthermore, as the device name implies (Continuous Passive Motion (CPM)), it only allows for passive movement. There are no specific settings for the hip and ankle. Movement in the frontal plane cannot be performed at the hip. While the knee and ankle are in a neutral position, flexion up to 90 degrees, as well as abduction / adduction movements, cannot be performed at the hip. Furthermore, during resistanceexercises, the resistance level cannot be adjusted instantly and dynamically according to the patient’s movement.

[0012] Patent document No. CN111481404A, in the known state of the art, relates to an adjustable hip joint exercise device capable of providing accurate feedback. However, the device described in this document does not overcome the disadvantages mentioned above. The device’s primary function is to provide passive movement via a servo motor. In other words, the device moves the patient’s leg; the patient cannot actively move it themselves. The rail mentioned in the text essentially only enables movement in a single plane, i.e., the hip joint’s flexion / extension (bending / straightening) motion. The text does not mention movements in other planes, such as abduction / adduction (moving outward / inward). With this device, hip abduction and adduction, flexion and extension of the hip joint in the vertical plane, flexion and extension of the knee joint, and dorsiflexion and plantar flexion of the ankle joint cannot be performed.

[0013] Brief Description of the Invention

[0014] The object of the invention is to develop a device designed to provide patients with more effective treatment at a lower cost during the early rehabilitation period for individuals with lower extremity problems (such as post-surgical, post-traumatic, or post-stroke conditions).

[0015] Another object of the invention is to develop a device that can be easily used by individuals who are unable to perform active movements in their lower extremities or who have lost muscle strength.

[0016] A further object of the invention is to reduce the need for physical therapists to work one-on-one with patients in hospitals or rehabilitation centers, thereby minimizing labor loss.

[0017] Description of the Figures

[0018] Figure 1: A perspective view of the device subject to the invention.Description of References in the Figures

[0019] To provide a better understanding of the invention, the corresponding numbers in the figures are provided below:

[0020] 1. Lower extremity exercise device

[0021] 1.1. Knee- Ankle-Foot Orthosis (KAFO)

[0022] 1.1.1. Foot support section

[0023] 1.1.2. Calf support section

[0024] 1.1.3. Thigh support section

[0025] 1.1.4. First securing strap

[0026] 1.1.5. Anklejoint

[0027] 1.1.6. Knee joint

[0028] 1.1.7. Distal side bar

[0029] 1.1.8. Proximal side bar

[0030] 1.2. Rail system

[0031] 1.2.1. First rail

[0032] 1.2.2. Second rail

[0033] 1.2.3. Third rail

[0034] 1.3. Sliding component

[0035] 1.4. Hip securing component

[0036] 1.4.1. Hip joint

[0037] 1.4.2. Second securing strap

[0038] Detailed Description of the Invention

[0039] The lower extremity exercise device (1) of the invention comprises at least one knee-ankle-foot orthosis (KAFO) (1.1), at least one rail system (1.2) which comprises at least one third rail (1.2.3) extending horizontally from the hip securing component (1.4) to the floor, further at least one first rail (1.2.1) that is perpendicular to the floor and designed to be removable from and attachable to the device (1), and / or at least one second rail (1.2.2) that is horizontal to the floorbut perpendicular to the third rail (1.2.3) and designed to be removable from and attachable to the device (1), wherein these rails are interconnected, thereby the movement in these two or three planes (forward-backward, up-down, left-right) are enabled; at least two sliding components (1.3) connected to the foot support section (1.1.1) and the thigh support section (1.1.3) to perform flexion and extension movements in the hip and knee joints and to perform abduction and adduction movements of the hip joint in the frontal plane, and designed to slide along the rails within the rail system (1.2), at least one hip securing component (1.4), and at least one control unit (not shown in the figure) that allows for the programming exercise type, joint angles, resistance level, repetition count, and / or other parameters.

[0040] The first rail (1.2.1) allows the hip joint to perform vertical flexion movements up to 90 degrees by enabling the sliding component (1.3), attached to the foot support section (1.1.1), to slide along it while the knee joint is in the neutral position. The second rail (1.2.2) allows the hip joint to perform abduction and adduction movements while the knee joint is in the neutral position. The third rail (1.2.3) enables the hip and knee joints to perform flexion and extension exercises.

[0041] The KAFO (1.1) comprises at least one foot support section (1.1.1) used to secure the user’s foot, at least one calf support section (1.1.2) that supports the calf from the proximal side of the ankle to the distal side of the knee joint from below, at least one thigh support section (1.1.3) that supports the thigh from the proximal side of the knee joint to the distal side of the hip joint, at least two first securing straps (1.1.4) to secure the user’s leg and thigh to the support sections, at least one ankle joint (1.1.5) that adjusts the ankle joint angle, at least two knee joints (1.1.6) positioned on opposing side bars to adjust the knee joint angle, at least two distal side bars (1.1.7) comprising multiple telescopic bars, thereby allowing the length to be adjusted to fit the user, connected to the calf support section (1.1.2) on both the inner and outer sides, and positioned between the knee joint (1.1.6) and the ankle joint (1.1.5), at least two proximal side bars (1.1.8) comprising multiple telescopic bars, thereby allowing the length to be adjusted to fit the user, connected to the thigh support section (1.1.3) on both the inner and outer sides, and positioned between the knee joint (1.1.6) and the hip joint (1.4.1), at least one motor (not shown in the figure) for each joint that enables passive, adjustable active-assisted, active, and adjustable resistance exercises, that is positioned in an integrated manner with the knee and ankle joints(1.1.6, 1.1.5) to enable said joints (1.1.6, 1.1.5) to perform the required movements at predetermined angles, at predetermined speeds, and / or with resistance as needed; at least one angular sensor (not shown in the figure) operating in synchronization with the motors, used to measure the range of motion of the joints and evaluate the accuracy of the movement, sending data regarding joint angles to the motor to ensure the proper adjustments to be made, positioned on the hip joints (1.1.6, 1.1.5).

[0042] Hip securing component (1.4) comprises at least two hip joints (1.4.1) that adjust the hip joint angle, at least one motor for each that is positioned in an integrated manner with the hip joints (1.4.1) to enable said joints (1.4.1) to perform the required movements at predetermined angles, at predetermined speeds, and / or with resistance as needed, at least one angular sensor operating in synchronization with the motors, used to measure the range of motion of the joints and evaluate the accuracy of the movement, sending data regarding joint angles to the motor to ensure the proper adjustments to be made, positioned on the hip joints (1.4.1), and at least one second securing strap (1.4.2) that secures the user’s torso.

[0043] The device (1) subject to the invention comprises at least one battery (not shown in the figure) used as a power source for the motors positioned at the hip, knee, and ankle joints (1.4.1, 1.1.6, 1.1.5).

[0044] In one embodiment of the invention, the device (1) comprises at least one communication unit that enables the control unit to perform functions such as stopping the system in emergency situations, monitoring the patient’s exercise progress, programming exercises, and remotely transmitting / receiving related data, and that allows communication between the device (1) and at least one user interface. This allows for the remote adjustment of movement angles and resistance levels during resistance exercises, aiming to facilitate a more effective treatment process. The communication unit transmits rehabilitation-related information to a server and receives feedback from the server.

[0045] In one embodiment of the invention, the device (1) comprises interfaces (preferably digital screens) (not shown in the figure) integrated onto the hip, knee, and ankle joints (1.4.1, 1.1.6,1.1.5) that provide visual feedback to the user by instantly displaying joint angles based on data received from angular sensors during movement. These screens contribute to ensuring the exercise is performed in accordance with the targeted angle.

[0046] In one embodiment of the invention, the securing straps (1.1.4, 1.4.2) include Velcro.

[0047] The device (1) subject to the invention comprises motors at the hip, knee, and ankle joints (1.4.1, 1.1.6, 1.1.5) and offers the ability to perform movements passively, with active assistance, actively, and with adjustable resistance. The device (1) features adjustable joint angles and resistance levels via angular sensors, specifically enabling hip flexion and extension, abduction and adduction movements in the frontal plane at the hip joint, knee flexion and extension, and dorsiflexion and plantar flexion movements at the ankle. Additionally, it provides functional rehabilitation by enabling hip flexion / extension movements up to 90 degrees in the vertical plane. This feature is not present in devices of the prior art.

[0048] In one embodiment of the invention, the control unit detects predefined emergency situations and, if an emergency occurs, the device (1) stops the rehabilitation process. If the control unit detects a mismatch between the data from the angular sensors and the motors, the device (1) automatically stops via the control unit to ensure the user’s safety and prevent potential harm or incorrect movements. The situations where such a mismatch may occur are listed as follows:

[0049] Exceeding the Range of Motion:

[0050] • If device (1) reaches an angle that exceeds the patient’s joint range of motion and this angle surpasses the patient’s tolerance level, the control unit can detect this and stop device (1).

[0051] Unexpected Resistance or Spasm:

[0052] • If the patient experiences a sudden spasm or muscle contraction and the device (1) cannot complete the movement, it can detect this and stop.Motor and Sensor Mismatch:

[0053] • If a mismatch is detected between the motor movement and the angular sensor data, the device (1) may be performing an incorrect movement.

[0054] Excessive Force Detection:

[0055] • If the extremity being moved by the device (1) exhibits resistance beyond the normal range, this may be due to an obstacle or the patient’s discomfort.

[0056] Connection Errors or Sensor Malfunctions:

[0057] • If there is an inconsistency in the data from the angular sensors or motors, the device (1) will stop as a safety precaution.

[0058] With this device (1), it will be possible to ensure that the ankle-knee-hip joints function at the desired ROM without the need for patients to come to the hospital. Stabilizing the hip joint will also enable more effective knee angles.

[0059] This invention is a device that can be used in hospitals’ intensive care units, all centers providing neurological rehabilitation, and patients’ homes following orthopedic surgeries. It will enable controlled movement during the early rehabilitation period. For example, through a mobile app, physical therapists or clinicians will be able to monitor how much patients are exercising at home, track their exercise progress, and adjust the ROM values as needed.

[0060] The device (1) of the invention can be used following knee ligament surgery, meniscus surgery, knee replacement surgery, and hip replacement surgery. Additionally, for individuals with insufficient lower extremity muscle strength and / or those requiring lower extremity muscle strengthening, the device will allow them to comfortably perform exercises at home, including hip, knee, and ankle ROM, without the need for a physical therapist or healthcare professional,enabling them to perform passive, active-assisted, active, or resistance-based (for muscle strengthening) exercises. (Resistance can be automatically adjusted according to the patient’s muscle strength, and the resistance level is increased as muscle strength improves.)

[0061] By eliminating the need for patients to visit the hospital daily, overall costs can be reduced. Joint stability can be enhanced to achieve the most effective angles. Patients’ progress levels can be monitored remotely, and appropriate steps can be selected to support their development. Thanks to motor integration into the device’s (1) extremity joints (hip, knee, ankle), specialized movements can be added to focus on the joint.

[0062] The advantages of the device (1) of the invention are summarized below:

[0063] Multi- Joint Integration: The lower extremity exercise device (1) subject to the invention comprises motors in the hip, knee, and ankle joints (1.4.1, 1.1.6, 1.1.5). Thus, while existing CPM devices are generally designed for only the knee or hip joint, this device (1) provides integrated movement for multiple joints, offering a more comprehensive rehabilitation option.

[0064] Thanks to the motors used in the joints:

[0065] o ROM control is provided at the hip, knee, and ankle,

[0066] o It enables passive, active-assisted, active, and resistance exercises.

[0067] Advanced Movement Capabilities: Device (1) is capable of performing flexion and extension in the knee joint, dorsiflexion and plantar flexion in the ankle joint, and abduction and adduction in the frontal plane along with flexion and extension in the vertical plane in the hip joint. Additionally, the rail system (1.2) enables the hip to flex up to 90 degrees while the knee and ankle joints are in a neutral position, and allows for movement in the frontal planes, thereby contributing to functional rehabilitation.

[0068] Angular sensors: These allow for more precise adjustment of joint angles, instantly measure joint range of motion, and evaluate movement accuracy.

[0069] Digital- Assisted Feedback: Integrated digital screens on the joints provide the patient with real-time visual feedback, ensuring exercises are performed at the correct angles. Smart Control and Bluetooth Integration:o Device (1) settings (e.g., exercise type, joint angles, repetition count) can be adjusted via a mobile app using a Bluetooth connection.

[0070] o During active resistance exercises, resistance can be adjusted according to the patient’s muscle strength, and the resistance level can be increased as muscle strength improves.

[0071] o The rehabilitation process can be monitored and controlled remotely. o The patient’s exercise progress can be tracked, and remote data transmission is supported.

[0072] o In emergency situations, the system can be remotely shut down, thereby enhancing patient safety.

[0073] Error Detection and Safety Mechanism: When sensors detect inconsistencies with motor movements, the automatic safety mechanism is activated and the device (1) stops, thereby preventing injury to the patient.

[0074] By stabilizing the hip joint, more effective knee angles will be achieved during exercises.

[0075] Fully Foldable and Portable Design: Device (1) is designed to be foldable and with components that nest inside one another, allowing it to be stored in minimal space and easily transported. It is also adjustable to the user’s height.

[0076] Industrial Applicability of the Invention

[0077] This invention relates to an individually adjustable lower extremity exercise device (1) designed to provide patients with more effective treatment at a lower cost during the early rehabilitation period for individuals with lower extremity problems (such as post-surgical, post-traumatic, or post-stroke conditions).

[0078] The invention is not limited to the above descriptions; a person skilled in the art can readily identify various embodiments of the invention. These should be evaluated within the scope of protection set out in the claims.

Claims

CLAIMS1. A lower extremity exercise device (1) designed to provide patients with more effective treatment at a lower cost during the early rehabilitation period for individuals with lower extremity problems, comprising at least one knee-ankle-foot orthosis (KAFO) (1.1) which comprises at least one foot support section (1.1.1) used to secure the user’s foot, at least one calf support section (1.1.2) that supports the calf from the proximal side of the ankle to the distal side of the knee joint from below, at least one thigh support section (1.1.3) that supports the thigh from the proximal side of the knee joint to the distal side of the hip joint, at least two first securing straps (1.1.4) to secure the user’s leg and thigh to the support sections, at least one ankle joint (1.1.5) that adjusts the ankle joint angle, at least two knee joints (1.1.6) positioned on opposing side bars to adjust the knee joint angle, at least two distal side bars (1.1.7) comprising multiple telescopic bars, thereby allowing the length to be adjusted to fit the user, connected to the calf support section (1.1.2) on both the inner and outer sides, and positioned between the knee joint (1.1.6) and the ankle joint (1.1.5), at least two proximal side bars (1.1.8) comprising multiple telescopic bars, thereby allowing the length to be adjusted to fit the user, connected to the thigh support section (1.1.3) on both the inner and outer sides, and positioned between the knee joint (1.1.6) and the hip joint (1.4.1), at least one motor for each joint that is positioned in an integrated manner with the knee and ankle joints (1.1.6, 1.1.5) to enable said joints (1.1.6, 1.1.5) to perform the required movements at predetermined angles, at predetermined speeds, and / or with resistance as needed; and comprising at least one battery used as a power source for the motors,characterized by comprising at least one rail system (1.2) which comprises at least one third rail (1.2.3) extending horizontally from the hip securing component (1.4) to the floor, further at least one first rail (1.2.1) that is perpendicular to the floor and designed to be removable from and attachable to the device (1), and / or at least one second rail (1.2.2) that is horizontal to the floor but perpendicular to the third rail (1.2.3) and designed to be removable from and attachable to the device (1), wherein these rails are interconnected, thereby the movement in these two or three planes are enabled; at least two sliding components (1.3) connected to the foot support section (1.1.1) and the thigh support section (1.1.3) to perform flexion and extension movements in the hip and knee joints and to perform abduction and adductionmovements of the hip joint in the frontal plane, and designed to slide along the rails within the rail system (1.2), at least one hip securing component (1.4) which comprises at least two hip joints (1.4.1) that adjust the hip joint angle, at least one motor for each that is positioned in an integrated manner with the hip joints (1.4.1) to enable said joints (1.4.1) to perform the required movements at predetermined angles, at predetermined speeds, and / or with resistance as needed, at least one angular sensor operating in synchronization with the motors, used to measure the range of motion of the joints and evaluate the accuracy of the movement, sending data regarding joint angles to the motor to ensure the proper adjustments to be made, positioned on the hip joints (1.4.1), and at least one second securing strap (1.4.2) that secures the user’s torso; the KAFO also comprises at least one angular sensor operating in synchronization with the motors, used to measure the range of motion of the joints and evaluate the accuracy of the movement, sending data regarding joint angles to the motor to ensure the proper adjustments to be made, positioned on the hip joints (1.1.6, 1.1.5); and at least one control unit that allows for the programming exercise type, joint angles, resistance level, repetition count, and / or other parameters.

2. The lower extremity exercise device (1) according to Claim 1, characterized by comprising a control unit that automatically stops the device (1) if it detects a mismatch between the data from the angular sensors and the motors.

3. The lower extremity exercise device (1) according to Claim 2, characterized by comprising at least one communication unit that enables the control unit to perform functions such as stopping the system in emergency situations, monitoring the patient’s exercise progress, programming exercises, and remotely transmitting / receiving related data, and that allows communication between the device (1) and at least one user interface.

4. The lower extremity exercise device (1) according to any one of the preceding claims, characterized by comprising an interface for each that is integrated onto the hip, knee, and ankle joints (1.4.1, 1.1.6, 1.1.5) and provides visual feedback to the user by instantly displaying joint angles using data received from angular sensors during movement.

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