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 aim of this multi-site clinical trial was to determine the safety, reliability, and feasibility of using the ReStore exosuit during post-stroke rehab. 44 users presenting with hemiparesis following a stroke completed 5 days of training with the ReStore, with walking assessments performed prior to and following the training series. Each session with the ReStore device was comprised of up to 20 minutes of treadmill walking and up to 20 minutes of overground walking. The primary endpoint was assessed as the frequency of device-related adverse events during the study (including device-related serious adverse events and falls); Secondary endpoints of clinician safety and device reliability were assessed as the frequency of device-related injuries experienced by physical therapists during the study and device malfunctions during device usage, respectively. There were no device-related falls or serious adverse events reported. A low rate of device malfunctions was reported by clinician-operators. Following the 5 sessions of walking practice with the ReStore exosuit, study participants increased both their device-assisted and unassisted maximum walking speeds. The authors concluded that the ReStore exosuit is safe and reliable for use during gait training on a treadmill and overground in post-stroke rehabilitation.
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