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.
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 [MAI]). 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.
D000328:Adult; D001132:Arm; D003627:Data Interpretation, Statistical; D006801:Humans; D009068:Movement; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000592:standards; D010349:Patient Compliance; D018579:Patient Selection; D026741:Physical Therapy Modalities / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D020127:Recovery of Function; D018401:Sample Size; D020521:Stroke / Q000503:physiopathology / Q000628:therapy*