AGREE: an upper limb motorized exoskeleton for restoring arm functions: a single-blinded randomized controlled trial.
Marta Gandolla, Beatrice Luciani, Valeria Longatelli and 5 others
PMID 40500718WHAT IT FOUND
Adding the AGREE exoskeleton to standard therapy did not improve arm function more than standard therapy alone.
Both groups improved similarly. Patients rated the device as usable, but the robotic group received less active practice time due to setup delays.
Key findings
01The primary outcome was usability, not clinical efficacy; patients rated the system as acceptable with a median score of 68.7.
02Both the robotic and control groups showed significant improvements in arm function from baseline to post-treatment, but there was no significant difference between the groups.
03The experimental group received significantly less active practice time than the control group, averaging 12.81 minutes per session compared to the scheduled 45 minutes.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
Small sample size (30 participants) limits statistical power and generalizability. The primary outcome was usability, not clinical efficacy, so the study was not powered to detect differences in functional recovery. The experimental group received significantly less active practice time (mean 12.81 min) than the control group (45 min), confounding the comparison of therapeutic dose. Therapists were not familiar with the technology, which may have increased setup time and affected implementation fidelity. The device did not directly actuate wrist and hand movements, potentially limiting gains in distal function.
Declared interests
The study was funded by Regione Lombardia. The authors declared no other conflicts of interest.
The easy way to misread this
Do not conclude that robotic therapy is ineffective. The null finding may be due to the small sample size and the fact that the robotic group received much less active practice time than the control group due to setup delays. The study primarily validates usability, not comparative efficacy.