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The EXCITE Randomized Clinical Trial

Steven L. Wolf, PhD, PT; Carolee J. Winstein, PhD, PT; J. Philip Miller, AB; Edward Taub, PhD; Gitendra Uswatte, PhD; David Morris, PhD, PT; Carol Giuliani, PhD, PT; Kathye E. Light, PhD, PT; Deborah Nichols-Larsen, PhD, PT; for the EXCITE Investigators

JAMA. 2006;296:2095-2104.

Context  Single-site studies suggest that a 2-week program of constraint-induced movement therapy (CIMT) for patients more than 1 year after stroke who maintain some hand and wrist movement can improve upper extremity function that persists for at least 1 year.

Objective  To compare the effects of a 2-week multisite program of CIMT vs usual and customary care on improvement in upper extremity function among patients who had a first stroke within the previous 3 to 9 months.

Design and Setting  The Extremity Constraint Induced Therapy Evaluation (EXCITE) trial, a prospective, single-blind, randomized, multisite clinical trial conducted at 7 US academic institutions between January 2001 and January 2003.

Participants  Two hundred twenty-two individuals with predominantly ischemic stroke.

Interventions  Participants were assigned to receive either CIMT (n = 106; wearing a restraining mitt on the less-affected hand while engaging in repetitive task practice and behavioral shaping with the hemiplegic hand) or usual and customary care (n = 116; ranging from no treatment after concluding formal rehabilitation to pharmacologic or physiotherapeutic interventions); patients were stratified by sex, prestroke dominant side, side of stroke, and level of paretic arm function.

Main Outcome Measures  The Wolf Motor Function Test (WMFT), a measure of laboratory time and strength-based ability and quality of movement (functional ability), and the Motor Activity Log (MAL), a measure of how well and how often 30 common daily activities are performed.

Results  From baseline to 12 months, the CIMT group showed greater improvements than the control group in both the WMFT Performance Time (decrease in mean time from 19.3 seconds to 9.3 seconds [52% reduction] vs from 24.0 seconds to 17.7 seconds [26% reduction]; between-group difference, 34% [95% confidence interval {CI}, 12%-51%]; P<.001) and in the MAL Amount of Use (on a 0-5 scale, increase from 1.21 to 2.13 vs from 1.15 to 1.65; between-group difference, 0.43 [95% CI, 0.05-0.80]; P<.001) and MAL Quality of Movement (on a 0-5 scale, increase from 1.26 to 2.23 vs 1.18 to 1.66; between-group difference, 0.48 [95% CI, 0.13-0.84]; P<.001). The CIMT group achieved a decrease of 19.5 in self-perceived hand function difficulty (Stroke Impact Scale hand domain) vs a decrease of 10.1 for the control group (between-group difference, 9.42 [95% CI, 0.27-18.57]; P=.05).

Conclusion  Among patients who had a stroke within the previous 3 to 9 months, CIMT produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least 1 year.

Trial Registration  clinicaltrials.gov Identifier: NCT00057018

Author Affiliations: Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, Ga (Dr Wolf); Departments of Biokinesiology and Physical Therapy and Neurology, Keck School of Medicine, University of Southern California, Los Angeles (Dr Winstein); Division of Biostatistics, Washington University School of Medicine, St Louis, Mo (Mr Miller); Departments of Psychology (Drs Taub and Uswatte) and Physical Therapy (Dr Morris), University of Alabama at Birmingham; Department of Allied Health Science, Curriculum in Human Movement Science, Division of Physical Therapy, University of North Carolina at Chapel Hill School of Medicine (Dr Giuliani); Department of Physical Therapy, College of Public Health and Health Professions, University of Florida, Gainesville (Dr Light); and School of Allied Medical Professions, Ohio State University, Columbus (Dr Nichols-Larsen).

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