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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
Carolee J. Winstein
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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