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Home > "I" Clinical Trials Conditions > Improving Arm Mobility and Use after Stroke  Improving Arm Mobility and Use after Stroke
Improving Arm Mobility and Use after Stroke
For Condition: Cerebrovascular Accident
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Neurological Disorders and Stroke (NINDS)
Synopsis: An individual suffering a stroke or other brain injury may lose function on one side of the body (partial paralysis). As the individual shifts activities to favor the unaffected side, the problem worsens. Constraint induced (CI) therapy forces the individual to use the neglected arm by restraining the good arm in a sling. This study examines the effectiveness of CI therapy for improving arm motion after stroke.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 3 to 9 months post cerebral infarct or 1 year post injury - 2.5 or lower on the Motor Activity Log scale - >= 10 degrees of active wrist extension - >= 10 degrees of extension of all joints of thumb and two other digits - Ability to perform wrist/finger extension movements three times within one minute
Total Enrollment: 230
Location and Contact Information:
Overall Study Official:
StevenWolf, Principal Investigator, Emory University
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7135
United States
University of Southern California
Los Angeles, California, 9009-9006
United States
Emory University
Atlanta, Georgia, 30322
United States
University of Florida
Gainesville, Florida, 32610-0154
United States
Ohio State University
Columbus, Ohio, 43210-1234
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Wake Forest University School of Medicine
Winston Salem, North Carolina, 27157
United States
Additional Information:
Study ID Numbers: R01 HD37606;
Study Start Date: March 2000
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057018
Other Cerebrovascular Accident Studies:
1. Multi-Ethnic Study of Atherosclerosis (MESA)
2. Carotid Atherosclerosis Follow-up Study
3. Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation
4. Adjunctive Drug Treatment for Ischemic Stroke Patients
5. Improving Arm Mobility and Use after Stroke
Related Studies:
Other Cerebrovascular Accident Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Improving Arm Mobility and Use after Stroke
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