Hands-free Atalante exoskeleton in post-stroke gait and balance rehabilitation: a safety study.
Thierry Lejeune, Dijana Nuic, Stéphanie Dehem and 10 others
PMID 40221748WHAT IT FOUND
Hands-free exoskeleton training was safe for stroke patients unable to walk.
Skin cuts and knee pain were minor and rare. Patients improved walking speed and balance over five sessions, but without a control group, this cannot prove the device caused the change.
Key findings
01No serious adverse events were linked to the device, and non-serious events like skin lacerations were minor.
02Gait speed and balance scores improved significantly after training, but the study had no control group to separate this from natural recovery.
03Participants reported high satisfaction and successfully completed usability tasks like walking forward and sideways.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
No control group, so improvements cannot be distinguished from natural recovery or conventional therapy effects. Small sample size (31 completers) and heterogeneous population (subacute and chronic stroke). Short intervention period (five sessions) limits conclusions on long-term efficacy. Conventional therapy components were not standardized or recorded, making it impossible to isolate the exoskeleton's contribution.
Declared interests
The study was sponsored by Wandercraft, the manufacturer of the Atalante exoskeleton, and was part of the FDA clearance submission process.
The easy way to misread this
Do not interpret the improvements in gait speed and balance as proof that the exoskeleton is more effective than standard care. This was a safety study with no control group, and the majority of participants were in the subacute phase where spontaneous recovery is common.