The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation.
Louis N Awad, Alberto Esquenazi, Gerard E Francisco and 2 others
PMID 32552775WHAT IT FOUND
Using a soft robotic exosuit for gait training was safe and feasible for stroke patients when supervised by physical therapists.
After five sessions, patients walked faster both with and without the device. This pilot shows the technology works in clinics, but it does not prove the device improves long-term walking.
Key findings
01There were no device-related falls or serious adverse events, and device-related adverse events occurred in less than 10% of visits.
02After five days of practice, participants increased their maximum walking speed by an average of 0.10 m/s with the device and 0.07 m/s without it.
03Physical therapists rated the device as easy to operate but gave the lowest satisfaction score for the time required to put on and take off the suit.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
This was a pilot study with no control group, so it cannot determine if the walking speed improvements were due to the device, the extra practice, or natural recovery. The study was small (44 participants) and short-term (five visits), limiting the generalizability of the safety and feasibility findings. Adverse events were initially high due to improper fitting, which was corrected mid-study through re-training, suggesting that user error and training are major factors in safety. The exploratory nature of the walking speed analysis means these results should not be interpreted as evidence of clinical efficacy.
Declared interests
The study was funded by ReWalk Robotics, the manufacturer of the device.
The easy way to misread this
Do not interpret the walking speed improvements as proof that the device is more effective than standard therapy. This was an uncontrolled pilot study, and the speed gains may reflect the additional practice time or natural recovery rather than a specific therapeutic effect of the exosuit.