Objective: To evaluate the effect of a constraint mitten, worn on the unaffected upper limb, on the arm and hand function of participants with hemiplegia. To estimate the sample size for a future trial.
Design: An A-B-A design.
Setting: Inpatient, outpatient and domiciliary setting.
Subjects: Ten participants with mild to moderate residual upper limb hemiparesis, between 1 and 12 months post stroke.
Intervention: Following a two-week baseline period, 10 participants were advised to wear the constraint mitten on the unaffected upper limb for 9 waking hours/day for two weeks to encourage use of the hemiplegic arm. Existing levels of therapy continued during the whole study.
Main measures: The primary outcome measure was the Action Research Arm Test. At the end of the intervention phase participants completed a questionnaire. Participants also recorded their daily use of the constraint mitten during the intervention phase.
Results: A mean improvement in the Action Research Arm Test score of 4.0 points (95% confidence interval 1.7 to 6.2; P=00.016) was found during the intervention phase after correcting for background recovery. Mean compliance was 6.7 hours/day (74%), 90% of participants were positive about the intervention and would recommend the treatment to other stroke survivors, although 50% were relieved to stop the mitten-wearing phase.
Conclusions: The use of a constraint mitten in upper limb stroke rehabilitation may be a useful adjunct to enhance functional recovery with minimal additional resources. The positive findings from this preliminary study warrant a larger randomized controlled trial of 200 participants in total.