Treatment for Movement Problems in Elderly Stroke Patients

This study has been withdrawn prior to enrollment.
(Study withdrawn/terminated)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00059696
First received: May 1, 2003
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Disorders
Procedure: Constraint-Induced Movement Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Treatment for Excess Motor Disability in the Aged

Resource links provided by NLM:


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

Estimated Enrollment: 80
Study Start Date: December 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00059696

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-1170
Sponsors and Collaborators
Investigators
Principal Investigator: Edward Taub, Ph.D. University of Alabama at Birmingham
  More Information

Publications:
Taub, E. (1994). Overcoming learned nonuse: A new behavioral medicine approach to physical medicine. In J. G. Carlson, S. R. Seifert, & N. Birbaumer. (eds.) Clinical applied psychophysiology (pp. 185-220). New York: Plenum.
Taub E, Wolf, SL Constraint-Induced (CI) Movement techniques to facilitate upper extremity use in stroke patients. Topics in Stroke Rehabilitation, 3: 38-61, 1997.
Taub E, Crago JE, Uswatte, G: Constraint-Induced Movement Therapy: A new approach to treatment in physical rehabilitation. Rehabilitation Psychology 43: 152-170, 1998.

ClinicalTrials.gov Identifier: NCT00059696     History of Changes
Other Study ID Numbers: 2R01HD34273-04
Study First Received: May 1, 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):
Constraint-Induced Movement Therapy
CI therapy
Rehabilitation
Cerebrovascular accident
Upper extremity
Concentrated, extended practice
Limb restraint
Motor Deficits

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

ClinicalTrials.gov processed this record on September 14, 2014