Trial results for a study investigating soft exosuits for functional gait recovery in patients with Stroke were posted on ClinicalTrials.gov on 2025-08-14. The study observed that the control group achieved a mean change of 0.78 m/sec in the 10 Meter Walk Test, which was higher than the mean changes seen in the soft exosuit intervention groups.
Background
Stroke is a leading cause of long-term disability, frequently impairing motor function and gait. Effective rehabilitation is vital for recovery. While traditional physical therapy is standard, technologies like soft exosuits are being explored as adjuncts. These lightweight devices aim to provide targeted assistance during movement to improve walking ability in patients recovering from acute stroke.
Trial design
This completed study enrolled 26 participants with Stroke and Acute Stroke. The trial aimed to develop and evaluate the use of soft exosuits in patients post-stroke. The study included a single group using a Hip Flexion Soft Exosuit, a device group using a ReWalk ReStore Soft Exosuit, and a control group for comparison. The primary focus for these reported measurements was the change in the 10 Meter Walk Test, a common measure of walking speed and functional mobility.
Key results
The key measurements reported for the change in the 10 Meter Walk Test (m/sec) were as follows:
- For the AIM 1: Single Group (Hip Flexion Soft Exosuit), the mean change was 0.48 m/sec.
- For the AIM 2: Device Group (ReWalk ReStore Soft Exosuit), the mean change was 0.53 m/sec.
- For the AIM 2: Control Group, the mean change was 0.78 m/sec.
These values represent the mean improvement in walking speed over the course of the study for each respective group.
What this means
The results indicate that the control group demonstrated a greater mean improvement in walking speed (0.78 m/sec) compared to both the Hip Flexion Soft Exosuit group (0.48 m/sec) and the ReWalk ReStore Soft Exosuit group (0.53 m/sec). This suggests that, in this trial, the soft exosuits did not lead to superior functional gait recovery than the natural recovery or standard care observed in the control group. Further research with larger cohorts is needed to fully understand the potential role and efficacy of soft exosuits in acute stroke rehabilitation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06231511, titled "Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation", were posted on 2025-08-14 on clinicaltrials.gov.