Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation.
Rebecca Macaluso, Matt Giffhorn, Sara Prokup and 7 others
PMID 39080666WHAT IT FOUND
Average comfortable walking speed improved by 0.12 m/s after therapist-guided gait training with the GEMS-H, but that was below the 0.14 m/s clinically important gain.
Daily steps rose by 1,750 per day, and device-related adverse events were 0.81%.
Key findings
01Average self-selected comfortable walking speed improved by 0.12 m/s after training, but the group average did not meet the 0.14 m/s clinically important difference.
02Average daily steps increased by 1,750 steps per day, and 36 of 41 participants met the wear-time threshold for this analysis.
03Six adverse events were possibly device related, giving a device-related adverse event rate of 0.81%, and all six resulted in full recovery.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
41 participants completed the training, which is fewer than the 46 needed for about 80% power for the primary walking speed outcome. All participants were in a single group, so the study cannot separate the device's contribution from therapist-guided gait training, assistive devices or orthotics when needed, or continued recovery. The average walking speed gain was 0.12 m/s, below the 0.14 m/s clinically important difference. Training was conducted during COVID-19 in small spaces, which limited training intensity. Participants had to walk 10 m with no more than 1 person assisting, so results do not apply to non-ambulators. TMS analysis included only 16 participants, and daily step analysis included 36 of 41 participants.
Declared interests
The device studied was the Samsung GEMS-H, and Samsung and the Max Nader Center for Rehabilitation Technologies and Outcomes Research were named funders.
The easy way to misread this
Do not conclude that the exoskeleton alone caused the improvements. All participants received therapist-guided gait training while wearing the device, and assistive devices or orthotics were allowed, so the device's contribution cannot be separated. The average walking speed gain was 0.12 m/s, below the 0.14 m/s clinically important difference.