The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation
The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation
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DOI：
10.1186/s12984-020-00702-5
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发表时间：
2020-06-18
影响因子：
5.1
通讯作者：
Jayaraman, Arun
中科院分区：
文献类型：
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作者：
Awad, Louis N.;Esquenazi, Alberto;Jayaraman, Arun
背景：中风后数月或数年内的非典型行走限制了社区重新融合，降低了活动能力、健康和生活质量。ReWalk ReStore（TM）是一种软机器人外装服，设计用于通过主动辅助麻痹踝关节跖屈和背屈来辅助中风后行走的推进和离地间隙子任务。之前对该技术的概念验证评估表明，改善了步态力学和能量学，并使中风后轻偏瘫患者行走更快更远。我们试图确定的安全性，可靠性和可行性使用的ReStore（TM）在中风后rehabilitation.Methods：一个多站点的临床试验（NCT 03499210）进行了准备申请美国食品和药物管理局（FDA）。该研究包括44名中风后轻偏瘫患者，他们在跑步机和地面上完成了长达5天的ReStore（TM）训练。除了所有培训活动的安全性和设备可靠性的主要和次要终点外，在五次培训访视之前和之后，对多次暴露于使用设备对使用者最大步行速度（使用和不使用设备）的影响进行了探索性评估。36名研究参与者完成了所有5天的培训。未报告器械相关福尔斯或严重不良事件。临床医生-操作员报告的器械故障率较低。不管他们是否依赖辅助辅助设备，在使用该设备进行步行练习仅5天后，研究参与者增加了他们的设备辅助，（Delta：0.10 +/- 0.03 m/s）和无辅助（Delta：0.07 +/- 0.03 m/s）最大步行速度（P < 0.05）。当在有执照的理疗师的指导下使用时，ReStore（TM）软外装护具在术后期间使用是安全可靠的。中风步态康复，在跑步机和地上行走过程中为瘫痪踝关节跖屈和背屈提供有针对性的帮助。
Background: Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore (TM) 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 (TM) during post-stroke rehabilitation.Methods: 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 (TM) 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.Results: 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 (Delta: 0.10 +/- 0.03 m/s) and unassisted (Delta: 0.07 +/- 0.03 m/s) maximum walking speeds (P's < 0.05).Conclusions: When used under the direction of a licensed physical therapist, the ReStore (TM) 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.