Treatment for Movement Problems in Elderly Stroke Patients

United States Department of Health and Human Services (HHS)

Status and phase

Completed

Phase 2

Conditions

Cerebrovascular Disorders

Treatments

Procedure: Constraint-Induced Movement Therapy

Study type

Interventional

Funder types

NIH

Identifiers

NCT00059696

2R01HD034273-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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