Efficacy of a soft robotic exoskeleton for upper-limb rehabilitation in subacute stroke inpatient rehabilitation: a randomised controlled trial.
Kai Wen Elvina Tay, Pui Kit Tam, Qi Xie and 9 others
PMID 42763409WHAT IT FOUND
In subacute inpatient stroke, adding a soft robotic glove to conventional occupational therapy did not improve upper-limb outcomes more than adding supervised GRASP with wrist support to conventional occupational therapy.
Both groups improved similarly.
Key findings
01Both groups improved from baseline to follow-up, but the glove did not produce significantly greater improvement than supervised GRASP on the primary Fugl-Meyer upper-limb score or the secondary hand activity and quality-of-life scores.
02In an exploratory subgroup, the glove group had a higher distal hand sub-score at post-intervention (mean difference 3.06; p = 0.049), but not at follow-up.
03No intervention-related adverse events or device-related complications were reported during the trial.
STILL TO COME
How it was doneWhat they foundWhat it means for OTs
Read the rest of this summary
You get three full summaries a month, free, and we do not ask for a card. Search, the TL;DRs and your library stay unlimited either way.
What it does not show
The trial planned 130 participants but randomised 61 and analysed 58, so it was underpowered to detect small to moderate differences. Recruitment stopped before the planned sample size because the funding period ended. Both groups received conventional occupational therapy, and occupational therapists individualised progression in both arms, which may reduce the difference between the glove and GRASP. The control group received supervised GRASP, an established programme, so the null result may reflect a strong active comparator rather than proof that the glove does nothing. The positive distal hand finding was a post-hoc subgroup analysis, and the authors state the chance of at least one significant result by chance in that analysis was 0.64. Participants had a wide range of baseline upper-limb impairment, which may make it harder to detect effects, especially with ceiling effects in milder cases. Two participants could not achieve adequate fit with the glove because of hand size. No neurophysiological biomarkers such as motor evoked potentials were collected.
Declared interests
The study was sponsored by Enterprise Singapore and Roceso Technologies, Singapore, the company named with the EsoGLOVE device.
The easy way to misread this
Do not read the exploratory subgroup finding as evidence that the glove improves hand recovery. The primary outcome was null, the subgroup was post-hoc, and the trial was underpowered.