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Improving Arm Mobility and Use After Stroke

This study has been withdrawn prior to enrollment.
(Study terminated/withdrawn)
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00057018
First received: March 26, 2003
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Cerebrovascular Accident
Procedure: Constraint-induced movement therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 229
Study Start Date: April 2000
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057018

Locations
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
Investigators
Principal Investigator: Steven L Wolf, PhD/PT/FAPTA Emory University
  More Information

Additional Information:
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.
Taub E, Wolf SL: Constraint-Induced (CI) Movement techniques to facilitate upper extremity use in stroke patients. Top Stroke Rehabil 1997; 3:38-61.
Duncan PW: Synthesis of intervention trials to improve motor recovery following stroke.Top Stroke Rehabil 1997; 3:1-20.
Wolf SL, Blanton S, Baer H, Breshears J, Butler AJ. The emergence of repetitive task practice in upper extremity neurorehabilitation of patients with stroke: A critical review of constraint induced movement therapy and mechanisms related to TMS. The Neurologist 8:325-338, 2002.
Aycock DM, Blanton S, Clark PC, Wolf SL. What is constraint-induced therapy? Rehabil Nurs. 2004 Jul-Aug;29(4):114-5, 121.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00057018     History of Changes
Other Study ID Numbers: R01 HD37606
Study First Received: March 26, 2003
Last Updated: May 20, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014