Trial reportJournal of neuroengineering and rehabilitation2020
The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation.
Trial report in Journal of neuroengineering and rehabilitation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-site, Interventional, Non-comparative, Single-arm Trial to Evaluate the Safety of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Ischemic or Hemorrhagic Stroke
Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke
Who cites it
48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 173 citations in OpenAlex.
- Effects of soft robotic exosuit on ambulation ability in stroke patients: a systematic review.Biomedical engineering online · 2023Pooled it
- Satisfaction analysis of overground gait exoskeletons in people with neurological pathology. a systematic review.Journal of neuroengineering and rehabilitation · 2023Pooled it
- Control strategies used in lower limb exoskeletons for gait rehabilitation after brain injury: a systematic review and analysis of clinical effectiveness.Journal of neuroengineering and rehabilitation · 2023Pooled it
- Identifying candidates for torque-assisted exoskeleton for gait assistance after stroke: a pre-specified subgroup analysis.European journal of physical and rehabilitation medicine · 2026Trial
- Efficacy of bilateral soft exoskeleton training for people with subacute stroke: a randomized controlled trial.Journal of neuroengineering and rehabilitation · 2025Trial
- The Concept of Shaping Applied to Locomotor Interventions: Clinical and Robotic Strategies to Facilitate and Progress Variable Stepping Training at Higher Intensities.Neurorehabilitation and neural repair · 2026Review
- Clinical Application of Wearable Devices in Stroke Rehabilitation: A Scoping Review of Safety, Feasibility, and Adherence.Healthcare (Basel, Switzerland) · 2026Review
- Digital Health Approaches to Geriatric Rehabilitation: A Narrative Paper.Annals of rehabilitation medicine · 2026Article
- Evaluating the Feasibility of Technology-Based Interventions in Disability and Rehabilitation: Definitions, Considerations, and Dimensions.JMIR rehabilitation and assistive technologies · 2026Article
- Clinical trials of GPE-based muscle support algorithm for robotic hip exoskeleton: a pilot study.Scientific reports · 2025Article
- Comparison of Five Rehabilitation Interventions for Acute Ischemic Stroke: A Randomized Trial.Journal of clinical medicine · 2025Article
- A Lightweight Powered Hip Exoskeleton With Parallel Actuation for Frontal and Sagittal Plane Assistance.IEEE transactions on robotics : a publication of the IEEE Robotics and Automation Society · 2025Article
- Elastic textile-based wearable modulation of musculoskeletal load: A comprehensive review of passive exosuits and resistance clothing.Wearable technologies · 2025Review
- Comparison of Empirical and Reinforcement Learning (RL)-Based Control Based on Proximal Policy Optimization (PPO) for Walking Assistance: Does AI Always Win?Biomimetics (Basel, Switzerland) · 2024Article
- Muscular, temporal, and spatial responses to shoulder exosuit assistance during functional tasks.Journal of neurophysiology · 2024Article
- Article
- Implementation of a unilateral hip flexion exosuit to aid paretic limb advancement during inpatient gait retraining for individuals post-stroke: a feasibility study.Journal of neuroengineering and rehabilitation · 2024Article
- DE-AFO: A Robotic Ankle Foot Orthosis for Children with Cerebral Palsy Powered by Dielectric Elastomer Artificial Muscle.Sensors (Basel, Switzerland) · 2024Article
- Efficacy of a Soft Robotic Exoskeleton to Improve Lower Limb Motor Function in Children with Spastic Cerebral Palsy: A Single-Blinded Randomized Controlled Trial.Brain sciences · 2024Article
- Human-centered design of a novel soft exosuit for post-stroke gait rehabilitation.Journal of neuroengineering and rehabilitation · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAtypical 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.
methodsA 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.
resultsAll 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).
conclusionsWhen 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.
trial registrationNCT03499210. Prospectively registered on March 28, 2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.