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.

本提案最终确定了便携式踝关节机器人的设计，作为治疗设备，以扭转足下垂和恢复更安全 中风后独立行走，然后进行严格的随机临床试验，以建立这种新的临床证据， 市场应用。目前，没有治疗足下垂的解决方案，只有辅助设备（支架，手杖， 电刺激），不能逆转潜在的踝关节缺陷。与手臂机器人相比，下肢机器人 迄今为止，在中风患者中大部分都是不成功的，我们认为这是因为他们不强调意志的坚定， 调节运动学习。我们开创了模块化踝关节机器人技术， 学习利用阻抗控制进行缺陷严重性调整的按需辅助， 在整个步态周期中对子事件进行精确的辅助定时。我们的五项阳性临床研究使用这种栓系 研究设备显示，偏瘫踝关节运动学习转化为改善地面步态。最重要的是， 我们的随机研究表明，18次踝关节机器人综合跑步机训练（但不是坐着的机器人训练） 持久扭转足下垂，恢复麻痹腿推进，并促进在无辅助期间更安全的脚跟先脚着陆 步行，使85%的人能够自行丢弃踝关节支架或改用依赖性较低的辅助设备。灵感来自我们 研究结果表明，踝关节机器人介导的功能性运动学习是最有效地进行运动的背景下， 任务为导向的培训，我们追求完成一个重量更轻，符合人体工程学的便携式踝关节机器人（AMBLE）， 符合便携性和临床可用性标准，适用于在常规移动性重点物理治疗（PT）中无束缚佩戴。 第一阶段生产一个商业便携式踝关节机器人与所需的便携性（设备质量，电池寿命）;硬件设计 (FDA冻结）-微控制器软件（符合FDA标准）;以及充分的临床可用性（客户-治疗师性能 报告卡，自动可调辅助），满足关键的安全性，稳定性和舒适性指标（不脱离时间， 滑动、部件故障、皮肤擦伤/刺激），以便完全融入 物理治疗符合FDA要求的商业装置将在第一年（第1阶段）达到设计冻结;可行性 我们的先前电池操作版本已经在中风患者中显示出功能证明，这支持了这一点。 使用AMBLE作为治疗设备，通过机器人的内在测量能力进行优化，我们将机器人技术 康复范式超越重复的机器人引导的运动任务实践，走向沉浸式PT集成机器人 （PTR）。II期（3年）是一项设盲、随机临床试验，研究9周（18次）的 根据步态生物力学评估（初始接触时的踝关节角度， 峰值摆动踝关节角度，脚跟首次撞击次数-总步数%，步态速度;次要结局- 3D步态 生物力学，每日步行活动）和盲法临床医生评估（背屈主动活动范围，踝关节 肌肉力量、辅助设备需求）。我们的研究结果将确立足下垂逆转的安全性和初步疗效， 恢复生物力学上更安全的行走，作为一种新的市场应用，填补了未满足的需求，并将护理转向PT 将机器人外骨骼整合到其他受损的关节上。