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Methods for a Multisite Randomized Trial to Investigate the Effect of Constraint-Induced Movement Therapy in Improving Upper Extremity Function among Adults Recovering from a Cerebrovascular Stroke

Department of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, Winstein{at}usc.edu

J. Philip Miller

Division of Biostatistics, Washington University, School of Medicine, St. Louis, Missouri

Sarah Blanton

Center for Rehabilitation Medicine, Emory University School of Medicine, Atlanta, Georgia

Edward Taub

Department of Psychology, University of Alabama at Birmingham

Gitendra Uswatte

Department of Psychology, University of Alabama at Birmingham

David Morris

Department of Physical Therapy, University of Alabama at Birmingham

Deborah Nichols

Physical Therapy, School of Allied Medical Divisions, The Ohio State University, Columbus

Steven Wolf

Center for Rehabilitation Medicine, Emory University School of Medicine, Atlanta, Georgia

This article describes the study design, methodological considerations, and demographic characteristics of a phase III RCT to determine if 1) constraint-induced therapy (CI therapy) can be applied with therapeutic success 3 to 9 months after stroke across different sites, 2) gains that might occur persist over 2 years, 3) initial level of motor ability determines responsiveness to CI therapy, and 4) the treatment effect differs between those treated before 9 months and after 1 year. Six sites will screen and recruit poststroke survivors stratified on initial level of motor ability and after randomization allocate participants to immediate or delayed intervention. Primary outcomes include a laboratory-based measure of function (Wolf Motor Function Test [WMFT]) and a real-world participant-centered functional use measure (Motor Activity Log [MAL]). Secondary outcomes concern function, behavior, and compliance. This is the first multisite, single-blind RCT of a formal training intervention for upper extremity rehabilitation in subacute stroke in the United States.

Key Words: RCT • rehabilitation • stroke interventions • upper extremity • motor recovery • behavior

Neurorehabilitation and Neural Repair, Vol. 17, No. 3, 137-152 (2003)
DOI: 10.1177/0888439003255511


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