OBJECTIVE: To determine the efficacy, safety, and compliance with forced-use therapy (FUT) applied without additional "shaping" therapy during the rehabilitation phase of stroke. DESIGN: Prospective, randomized controlled trial. SETTING: Tertiary mixed rehabilitation center. PARTICIPANTS: Consecutive sample of 30 inpatients or outpatients with first stroke showing minimal movement of the arm and hand. Subjects who scored below 26 on the Mini-Mental State Examination were excluded. Seven subjects either did not provide consent or withdrew from the study. The remaining subjects were randomized into the control group (n = 13) and the FUT group (n = 10). INTERVENTION: FUT involved wearing a thick constraint mitten on the sound arm for as many as 6 hours a day. MAIN OUTCOME MEASURES: The Chedoke McMaster Impairment Inventory for arm, hand, postural control, and shoulder pain; Action Research Arm Test; grip strength; and FIM instrument. RESULTS: FUT subjects experienced 20% more recovery of the arm than did control subjects and more recovery of postural control (p = 0.04). Men benefited most from the program, and there was a tendency for FUT subjects to have more shoulder pain. Compliance was related to cognitive status. CONCLUSIONS: FUT, without shaping therapy, appears to augment arm recovery, but a larger sample is required to confirm these findings. The FUT mitten was safe and well tolerated; however, more research is needed to determine the relation between FUT and hemiplegic shoulder pain.

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