Department of Physical Therapy & Athletic Training, Boston University, Boston, MA, USA.
Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
J Neuroeng Rehabil. 2020 Jun 18;17(1):80. doi: 10.1186/s12984-020-00702-5.
Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation.
A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits.
All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05).
When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking.
NCT03499210. Prospectively registered on March 28, 2018.
中风后数月和数年的异常行走限制了社区融入，降低了移动能力、健康水平和生活质量。ReWalk ReStore™ 是一种软机器人外骨骼，旨在通过主动辅助瘫痪足踝的背屈和跖屈，帮助患者完成中风后行走的推进和地面间隙两个子任务。该技术的先前概念验证评估表明，在偏瘫患者中，使用该技术可改善步态力学和能量学，并提高行走速度和距离。我们旨在确定在中风后康复期间使用 ReStore™ 的安全性、可靠性和可行性。
一项多中心临床试验（NCT03499210）正在进行中，以准备向美国食品和药物管理局（FDA）申请。该研究纳入了 44 名中风偏瘫患者，他们在跑步机和地面上完成了最多 5 天的 ReStore™ 训练。除了对所有训练活动的安全性和设备可靠性进行主要和次要终点评估外，在 5 次训练访问前后，还对使用设备对患者在使用和不使用设备时的最大行走速度的多次暴露的影响进行了探索性评估。
所有 44 名研究参与者均完成了安全性和可靠性评估。36 名研究参与者完成了所有 5 天的训练。没有报告与设备相关的跌倒或严重不良事件。临床医生操作员报告设备故障的发生率较低。无论他们是否依赖辅助辅助设备，在仅使用该设备进行 5 天的步行练习后，研究参与者的设备辅助（Δ：0.10±0.03 m/s）和非辅助（Δ：0.07±0.03 m/s）最大行走速度均有所提高（P<0.05）。
在有执照的物理治疗师的指导下，ReStore™ 软外骨骼在中风后步态康复期间使用是安全可靠的，可以在跑步机和地面行走时为瘫痪足踝的背屈和跖屈提供针对性的辅助。
NCT03499210。于 2018 年 3 月 28 日前瞻性注册。
