Improving Arm Mobility and Use After Stroke
|ClinicalTrials.gov Identifier: NCT00057018|
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : September 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident||Procedure: Constraint-induced movement therapy||Phase 3|
Profoundly impaired motor dysfunction is a major consequence of stroke. As a result, a large number of the more than 700,000 people in America sustaining a stroke each year have limitations in motor ability and compromised quality of life. Therapeutic interventions designed to enhance motor function and promote independent use of an impaired upper extremity are quite limited.
CI movement therapy, or "forced use," involves motor restriction of the less effected upper extremity for 2 weeks. Over this time, repetitive use of the more effected upper extremity is promoted for many hours a day. This treatment produces long lasting improvements in extremity use among patients who are more than 1 year post-stroke and who have an ability to initiate some extension in wrist and digit joints.
This study will determine if CI therapy for a hemiparetic upper extremity in patients with sub-acute (3 to 9 months post-cerebral infarct) stroke will lead to functional improvements and enhanced quality of life measures more than usual care.
Patients are randomized into a treatment or usual care group and stratified by movement capability into higher and lower functioning categories. Higher functioning patients are defined as those who have at least 20 degrees of active wrist extension and 10 degrees of active finger extension at each digit joint. Lower functioning patients are defined as those with at least 10 degrees of wrist extension and 10 degrees of extension at each thumb joint and all joints of two other digits. Patients randomized into the control group receive treatment one year later to permit replication efforts for findings using this therapy in patients with chronic stroke.
The intervention consists of making patients use their impaired arms by constraining movement in the less impaired limb for most waking hours over a 2 week period. The constraint is a taped splint in which the hand rests to prevent limb use but enable protective responses. A micro-switch within the splint will permit monitoring of contact time (wearing). Each weekday for 2 weeks, patients come to the clinic/laboratory for specific task training. Evaluations in laboratory and actual use tests are made prior to treatment, 2 weeks later, and at 4 month intervals thereafter. Changes in psychosocial functioning will also be measured. Primary outcomes include the Wolf Motor Function Test and the Motor Activity Log. Secondary outcomes include Stroke Impact Scale, Actual Amount of Use Test, and accelerometry.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||229 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial|
|Study Start Date :||April 2000|
|Primary Completion Date :||March 2005|
|Estimated Study Completion Date :||January 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057018
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 9009-9006|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610-0154|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7135|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210-1234|
|Principal Investigator:||Steven L Wolf, PhD/PT/FAPTA||Emory University|