Treatment for Movement Problems in Elderly Stroke Patients

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: NCT00059696
Recruitment Status : Completed
First Posted : May 5, 2003
Last Update Posted : September 26, 2016
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

May 1, 2003
May 5, 2003
September 26, 2016
December 1999
November 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00059696 on Archive Site
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Treatment for Movement Problems in Elderly Stroke Patients
A Treatment for Excess Motor Disability in the Aged
After a stroke, many patients are left with an impaired arm. Restricting the use of the good arm may improve the use of the bad arm. In "Constraint-Induced Movement" therapy (CI therapy), the good arm is put in a sling to force increased use of the bad arm. The bad arm is also trained each day for several weeks. This study will evaluate the effectiveness of CI therapy in patients with chronic disability after stroke and whether the rate of recovery is decreased in elderly patients.

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.

Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Cerebrovascular Disorders
Procedure: Constraint-Induced Movement Therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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November 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • First stroke > 12 months prior to study entry
  • Impaired Flexor synergy, pronation and supination of forearm, active wrist extension, active finger extension, and active grasp and release
  • Minimum passive range of motion and spasticity criteria (defined as stroke patients who fall into approximately the second to lowest quartile of motor functioning as determined by the Fugl-Meyer Test)
  • Available for follow-up at the treatment site (3 years for control patients; 2 years for intervention patients)

Exclusion Criteria

  • Folstein Mini-Mental State Examination score < 24
  • Token Test of the Multilingual Aphasia Examination score < 36
  • Excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities) as determined by study officials
  • Serious uncontrolled medical conditions
  • Excessive pain in any joint of the affected extremity that could limit ability to cooperate with the intervention, as judged by study officials
  • Unable to stand independently for 2 minutes, transfer independently to and from the toilet, or perform sit-to-stand
  • Current participation in other pharmacological or physical intervention studies
  • Injections of anti-spasticity drugs into upper extremity musculature within the past 3 months or wish to have drugs injected in the foreseeable future
  • Any oral anti-spasticity drugs at study entry
  • Phenol injections within 12 months prior to study entry
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
2R01HD034273-04( U.S. NIH Grant/Contract )
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Edward Taub, Ph.D. University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP