Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial.
Jacqui H Morris, Alexandra John, Lucy Wedderburn and 2 others
PMID 30977382WHAT IT FOUND
No clear benefit was seen when adding dynamic Lycra orthoses to usual arm rehabilitation after stroke.
The usual-care group showed more improvement on several arm outcomes, and wear was linked to skin, swelling and discomfort problems.
Key findings
01The orthosis group did not show a consistent improvement advantage: at 0 to 8 weeks it had a slightly higher proportion improving by one Action Research Arm Test severity level, but at 0 to 16 weeks controls had a higher proportion, and adjusted comparisons for other arm outcomes favoured controls.
02Orthosis wear was linked to adverse reactions, including skin irritation, hand oedema, discomfort, restricted movement, paraesthesia and feeling too warm.
03Three of five early orthosis-group withdrawals involved arm pain, swelling or discomfort related to wear.
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
Only 43 of the planned 51 participants were recruited, and retention at 16 weeks was 55.6% in the orthosis group and 56.3% in controls. The study was a feasibility trial and did not conduct definitive hypothesis testing, so the differences between groups are not proven effects. Participants and rehabilitation therapists could see allocation, and the outcome assessor was unblinded in 13 cases. Orthosis wear diaries were poorly completed, with only 5 entries covering the planned 56 days, so actual wear time is uncertain. Usual rehabilitation was poorly recorded, with only 17 of 43 diaries returned, so the therapy each group actually received is unclear. Adverse reactions linked to orthosis wear were common, and three of five early orthosis-group withdrawals involved arm pain, swelling or discomfort.
Declared interests
The study was funded by the Chief Scientist Office at the Scottish Government. The authors declared no potential conflicts of interest.
The easy way to misread this
Do not conclude that dynamic Lycra orthoses improve arm recovery after stroke. This was a small feasibility trial without definitive hypothesis testing, the control group had higher scores on all measures at 8 and 16 weeks, and adverse reactions were linked to orthosis wear.