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, J. Philip Miller, Sarah Blanton, Edward Taub, Gitendra Uswatte, David Morris, Deborah Nichols, Steven Wolf

Research output: Contribution to journalArticlepeer-review

206 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)137-152
Number of pages16
JournalNeurorehabilitation and neural repair
Volume17
Issue number3
DOIs
StatePublished - Sep 2003

Keywords

  • RCT
  • behavior
  • motor recovery
  • rehabilitation
  • stroke interventions
  • upper extremity

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