Clinical trial shows robotic exosuit can be reliably used for post-stroke gait rehabilitation
A new clinical trial exploring the use of the ReWalk ReStore soft robotic exosuit for post-stroke rehabilitation to improve participants’ walking speed and distance has been hailed successful.
Published in the Journal of NeuroEngineering and Rehabilitation, the trial – ‘The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation’ – set out to determine the safety, reliability, and feasibility of using the ReStore during post-stroke rehabilitation.
People who have recovered from stroke frequently experience reduced mobility, health and quality of life. To help tackle this issue, 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.
ReWalk ReStore consists of motors worn at the waist that generate mechanical forces that are transmitted by cables to attachment points located proximally on a functional textile worn around the calf and distally on a shoe insole. For users who require medio-lateral ankle support in addition to ankle plantarflexion and dorsiflexion assistance, an optional textile component that prevents ankle inversion without restricting dorsiflexion and plantarflexion can also be used.
Inertial sensors that attach to a patient’s shoes measure gait events and automate the independent timing of the active ankle plantarflexion and dorsiflexion assistance provided by the robotic device. Load cell sensors located at the end of each cable are used to monitor the interaction between user and exosuit and ensure that the target level of assistance is achieved. A hand-held device with a graphical interface allows clinicians to monitor patients’ performance and select and progress, in real-time, the assistance parameters.
According to the trial, previous proof-of-concept evaluations of the exosuit demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis.
To test the effectiveness of ReStore, a multi-site clinical trial 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 five days of training with the ReStore on the treadmill and over ground, under the supervision of a licensed physical therapist.
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 and 36 study participants completed all five training days.
No device-related falls or serious adverse events were reported. Furthermore, a low rate of device malfunctions was reported by clinician-operators.
The trial revealed that regardless of their reliance on ancillary assistive devices, after five days of walking practice with the robotic exosuit, 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).
In conclusion, the study suggests that 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.