The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation

Abstract

Background: 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. 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™ 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 (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 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™ 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.

These legs were made for propulsion: advancing the diagnosis and treatment of post-stroke propulsion deficits

“…As part of a successful application to the United States Food and Drug Administration, the ReStore TM soft exosuit (ReWalk Robotics, Ltd., Marlborough, MA) (Fig. 6 , Left) recently underwent a multi-site safety, device reliability, and clinical feasibility trial [ 146 ]. The trial recruited 44 users with post-stroke hemiparesis from across five clinical sites.…”

An Evaluation of Three Kinematic Methods for Gait Event Detection Compared to the Kinetic-Based ‘Gold Standard’

“…Gait event detection from sensor data has also been leveraged in sensor-based rehabilitation systems. Detection of gait events such as IC and TC are crucial when considering use of orthotic or therapeutic interventions, especially in functional electrical stimulation (FES) [ 29 , 34 , 35 , 36 ] and rehabilitation robotic systems [ 37 , 38 , 39 ], that use gait events to synchronize stimulation delivery or actuator activation to particular gait phases. Although detection delays and timing estimation errors are inherent in kinematic-based gait phase detection methods when compared to the “gold standard” method (gait events from force plate data), the method used to estimate gait events themselves may impact the timing differences observed.…”

Discussion on the Rehabilitation of Stroke Hemiplegia Based on Interdisciplinary Combination of Medicine and Engineering

“…Another study of wearable robots showed that the step symmetry of all stroke patients was significantly improved after training [ 28 ]. ReWalk ReStore™ is a soft robotic exosuit that is designed to assist stroke patients in walking through actively assisting the ankle joint [ 29 ]. The data recorded by wearable sensors can be used to build models and reduce the high cost and time-consuming efforts of RCT verification.…”