Treatment for Movement Problems in Elderly Stroke Patients
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|ClinicalTrials.gov Identifier: NCT00059696|
Recruitment Status : Completed
First Posted : May 5, 2003
Last Update Posted : September 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Disorders||Procedure: Constraint-Induced Movement Therapy||Phase 2|
Stroke afflicts over 700,000 Americans each year. Behavioral techniques that impact plasticity of the nervous system need to be incorporated into practical, evidence-based therapeutic interventions. This is especially true at a time when the duration of treatments reimbursed by third party payers has shortened.
CI therapy was derived from basic research with animal subjects and human volunteers. Randomized, controlled studies indicate that it can substantially reduce the motor deficit of patients with mild to moderate chronic strokes and can increase their independence over a period of years. CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb. This gives rise to massed or concentrated repetitive use of the more affected extremity. CI therapy leads to a large increase in use-dependent cortical reorganization involving the recruitment of other regions of the brain in the innervation of the more affected extremity movement.
One of the main aims of the proposed research is to determine if CI therapy can be used with therapeutic success for increasing the amount of real-world extremity use in patients with chronic stroke. Another aim is to ascertain whether the locus of the lesion and its size, as determined by MRI, are factors influencing the extent to which motor function can be recovered through the use of CI therapy.
Eighty patients with chronic stroke will be randomly assigned to receive either CI therapy or a General Fitness control intervention. Two years after study entry, the patients in the control group will be crossed over to receive CI therapy. Primary outcome measures will be a laboratory motor function test and amount of extremity use in the real-world setting. Changes in psychosocial functioning will also be measured.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Treatment for Excess Motor Disability in the Aged|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||November 2004|
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 ClinicalTrials.gov identifier (NCT number): NCT00059696
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-1170|
|Principal Investigator:||Edward Taub, Ph.D.||University of Alabama at Birmingham|