Working... Menu

Improving Arm Mobility and Use After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057018
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : September 26, 2016
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Procedure: Constraint-induced movement therapy Phase 3

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial
Study Start Date : April 2000
Actual Primary Completion Date : March 2005
Study Completion Date : January 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057018

Layout table for location information
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
Emory University
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
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS)
Layout table for investigator information
Principal Investigator: Steven L Wolf, PhD/PT/FAPTA Emory University

Publications of Results:
Other Publications:
Taub E: Somatosensory deafferentation research with monkeys: Implications for rehabilitation medicine. In Ince LP (ed.) Behavioral Psychology in Rehabilitation Medicine: Clinical Applications. New York: Williams Wilkins, 1980, 370-401
Taub E, Pidikiti RD, DeLuca SC, Crago JE: Effects of motor restriction of an unimpaired upper extremity and training on improving functional tasks and altering brain/behaviors. In J. Toole (ed.), Imaging and Neurologic Rehabilitation. New York::Demos, 1996, 133-154.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00057018     History of Changes
Other Study ID Numbers: R01HD037606 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2003    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: May 2011

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
cerebrovascular accident
upper extremity
physical therapy
constraint-induced therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases