Portable Ankle Robotics to Reverse Foot Drop After Stroke.

便携式踝关节机器人可逆转中风后足下垂的情况。

• 批准号: 10401496
• 负责人: Bradley Hennessie
• 金额: $ 149.88万
• 依托单位: NEXTSTEP ROBOTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10401496
• 关键词: 3-Dimensional; Active Learning; Address; Ankle; Articular Range of Motion; Back; Biomechanics; Blinded; Calibration; Canes; Caring; Chronic; Client; Clinic; Clinical; Clinical Research; Clinical Trials; Computer software; Computers; Custom; Detection; Devices; Diagnostic; Dose; Electric Stimulation; Electronics; Engineering; Event; Exercise; Exposure to; Failure; Feedback; Foot-drop; Freezing; Gait; Generations; Goals; Guidelines; Heel; Human; Impairment; Industrialization; Joints; Knee; Left; Legal patent; Lower Extremity; Marketing; Measurement; Mechanics; Mediating; Microprocessor; Motor; Orthotic Devices; Outcome; Patients; Pattern; Performance; Peripheral; Phase; Physical therapy; Population; Randomized; Reporting; Research; Resolution; Robot; Robotics; Safety; Self-Help Devices; Severities; Skin; Somatotype; Stroke; System; Technology; Testing; Therapeutic; Time; Torque; Training; Translating; Walking; Weight; arm; battery life; clinically relevant; comparative efficacy; cost; design; disability; electric impedance; ergonomics; exoskeleton; fall risk; foot; functional electrical stimulation; graphical user interface; hemiparesis; hemiparetic stroke; improved; innovation; irritation; leg paresis; locomotor tasks; meetings; meter; motor control; motor learning; muscle strength; portability; post stroke; prediction algorithm; randomized, clinical trials; rehabilitation paradigm; restoration; robot assistance; robot control; robot exoskeleton; robot rehabilitation; secondary outcome; skin irritation; stroke patient; stroke survivor; therapeutically effective; treadmill; treadmill training; treatment effect; trial comparing; usability

This proposal finalizes the design of a portable ankle robot as a therapeutic device to reverse foot drop and restore safer independent walking after stroke, then conducts a rigorous randomized clinical trial to establish clinical proof for this new market application. Currently, there are no therapeutic solutions for foot-drop, only assistive devices (braces, canes, electrical stimulation) that don't reverse the underlying ankle deficits. In contrast to arm robotics, lower extremity robotics have been largely unsuccessful in stroke patients to date, we posit because they do not emphasize volitional engagment for mediating motor learning. We pioneered modular ankle robotics technology, enabling human-robotics cooperative learning utilizing impedance control for deficit severity adjusted assist-as-needed in conjunction with adaptive control for precise timing of assistance to sub-events across the gait cycle. Our five positive clinical studies using this tethered research device show hemiparetic ankle motor learning that translates into improved over-ground gait. Most importantly, our randomized study shows that 18 sessions of ankle robotics integrated treadmill training (but not seated robot training) durably reverses foot drop, restores paretic leg propulsion, and promotes safer heel-first foot landing during unassisted walking, enabling 85% to self-discard their ankle braces or switch to a less dependent assistive device. Inspired by our findings that ankle robot mediated functional motor learning is most effectively conducted in the context of locomotor task-oriented training, we pursue finalization of a lighter weight and ergonomic portable ankle robot (AMBLE) that meets portability and clinical usability standards for untethered wear into regular mobility focused physical therapy (PT). Phase I produces a commercial portable ankle robot with desired portability (device mass, battery life); hardware design (FDA freeze)-microcontroller software (FDA compliant); and adequate clinical usability (client-therapist performance report card, auto-adjustable assistance) that meets key safety, stability, and comfort metrics (don-disengage time, slippage, part failure, skin abrasions/irritations) during over-ground walking and mobility tasks for full integration into physical therapy. Commercial units meeting FDA requirements will reach design freeze the first year (Phase 1); feasibility of which is supported by our precedent battery operated version already showing proof-of-function in stroke patients. Using AMBLE as a therapeutic device, optimized by the robot's intrinsic measurement capacities, we shift the robotics rehabilitation paradigm beyond repetitive robot guided exercise task practice, toward immersive PT integrated robotics (PTR). Phase II (3-yrs) is a blinded, randomized clinical trial investigating the hypothesis that 9 weeks (18 sessions) of PTR is more effective than PT alone to reverse foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity; secondary outcomes- 3D gait biomechanics, daily ambulatory activity ) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs). Our results will establish safety and initial efficacy for reversal of foot drop and restoration of biomechanically safer walking as a new market application filling an unmet need, and shift care toward PT integrated robotic exoskeletons across other impaired joints.

该提案最终设计了便携式踝机器人作为一种治疗装置，以逆转脚部并恢复更安全 中风后独立行走，然后进行严格的随机临床试验，以建立此新的临床证明 市场应用。目前，没有用于脚步的治疗解决方案，只有辅助设备（牙套，拐杖， 电刺激）不会逆转下面的踝关节缺陷。与手臂机器人技术相反，下肢机器人技术 迄今为止，我们的中风患者在很大程度上都没有成功，我们认为他们没有强调自愿订婚 调解运动学习。我们开创了模块化脚踝机器人技术技术，使人类机器人合作 学习利用阻抗控制进行赤字严重程度调整了与自适应控制结合使用的辅助 在整个步态周期中为子事件提供援助的精确时机。我们使用这种束缚的五项积极临床研究 研究装置显示出偏瘫踝运动学习，可以转化为改进的地面步态。最重要的是， 我们的随机研究表明，18次脚踝机器人会综合跑步机训练（但不是坐在机器人培训） 持久地逆转脚部下降，恢复右腿的推进，并在无助的过程中促进更安全的脚跟优先降落 步行，使85％能够自我掩盖脚踝牙套或切换到较小的辅助设备。受我们的启发 在运动的背景下，脚踝机器人介导的功能运动学习的发现最有效 以任务为导向的培训，我们追求更轻巧的重量和符合人体工程学的便携式踝机器人（AMBLE） 符合常规迁移式物理疗法（PT）的可移植性和临床可用性标准。 第一阶段生产具有所需可移植性（设备质量，电池寿命）的商业便携式脚踝机器人；硬件设计 （FDA Freeze）-Microcontroller软件（符合FDA）；和足够的临床可用性（客户与治疗师的性能 报告卡，自动调整的帮助），可满足关键安全，稳定性和舒适度量（Don-Disengage Time， 滑板，部分失败，皮肤擦伤/刺激）在地面步行和移动性任务中，以完全集成到 物理疗法。满足FDA要求的商业单位将达到第一年的设计冻结（第1阶段）；可行性 其中的先例电池操作的版本支持中风患者的功能证明。 使用机器人的内在测量能力优化的Amble作为治疗装置，我们移动机器人技术 康复范式超出了重复的机器人指导性运动练习，朝着沉浸式PT综合机器人技术 （ptr）。 II阶段（3年）是一项盲目的，随机的临床试验，研究了9周（18个会话）的假设 如步态生物力学评估（初始接触时的脚踝角， 峰值秋千角度，脚后跟优先击球的数量 - ％总步骤，步态速度；次要结果-3D步态 生物力学，每日门诊活动）和盲目的临床医生评估（背屈运动范围的运动范围，脚踝 肌肉力量，辅助设备需求）。我们的结果将确立安全和初始功效，以逆转脚落和 恢复生物力学更安全的步行，作为满足未满足需求的新市场应用程序，并将其转移到PT 其他受损的关节中的综合机器人外骨骼。