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Improving Arm Mobility and Use After Stroke

The Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00057018
Enrollment
229
Registered
2003-03-28
Start date
2000-04-30
Completion date
2006-01-31
Last updated
2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

Keywords

stroke, cerebrovascular accident, upper extremity, physical therapy, constraint-induced therapy

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.

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.

Interventions

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026