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

• Published in: Journal of neuroengineering and rehabilitation 2020-06, Vol.17 (1), p.80-80, Article 80
• Main Authors: Awad, Louis N, Esquenazi, Alberto, Francisco, Gerard E, Nolan, Karen J, Jayaraman, Arun
• Format: Article
• Language: English
• Subjects: Adult; Ankle; Biomechanics; Clinical trials; Exoskeleton; Exoskeleton Device - adverse effects; Exosuit; Feasibility; Feasibility Studies; Female; Fitness equipment; Gait; Gait Disorders, Neurologic - etiology; Gait Disorders, Neurologic - rehabilitation; Humans; Male; Malfunctions; Middle Aged; Paresis; Paresis - etiology; Paresis - rehabilitation; Physical therapists; Physical therapy; Physical Therapy Modalities; Physiology; Quality of Life; Questionnaires; Regulatory agencies; Rehabilitation; Reliability analysis; Reproducibility of Results; Robotics - instrumentation; Safety; Soft robotics; Stroke; Stroke - complications; Stroke Rehabilitation - adverse effects; Stroke Rehabilitation - instrumentation; Technology assessment; Training; Treadmills; Walking
• ISSN: 1743-0003; 1743-0003
• 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