Upper Limb Training with a Dynamic Hand Orthosis in Early Subacute Stroke: A Pilot Randomized Trial.

Abstract

To investigate the effect of the addition of a dynamic hand orthosis to unilateral task-oriented training in early subacute stroke. Pilot randomized trial with concealed allocation, measurer blinding, and intention-to-treat analysis. Rehabilitation hospital. Thirty subacute stroke patients with moderate-to-severe upper limb disability. 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). 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. 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. No additional benefit was found of wearing a dynamic hand orthosis during unilateral taskoriented training in the early subacute period.