Abstract
OBJECTIVES: To investigate the effect of the addition of a dynamic hand orthosis to unilateral task-oriented training in early subacute stroke. DESIGN: Pilot randomized trial with concealed allocation, measurer blinding, and intention-to-treat analysis. SETTING: Rehabilitation hospital. PARTICIPANTS: Thirty subacute stroke patients with moderate-to-severe upper limb disability. INTERVENTION: All participants received 4 weeks (60 min per day, 5 days a week) of unilateral task-oriented training. The experimental group (n = 15) wore a dynamic hand orthosis during half of the training time (i.e. 30 min per day). OUTCOME MEASURES: Primary outcome was the upper limb activity measured using the Action Research Arm Test (ARAT) measured at baseline and 4 weeks. Secondary outcomes were the Nine-hole Peg Test, Fugl-Meyer Assessment for upper extremity, grip strength, modified Ashworth Scale, Barthel Index and EuroQol-5D. RESULTS: No difference between groups was found for the primary outcome ARAT (mean difference 4/57, 95% confidence interval (95% CI) -5 to 13) nor for any secondary outcome. CONCLUSION: No additional benefit was found of wearing a dynamic hand orthosis during unilateral taskoriented training in the early subacute period.