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Clinical Trials/NCT00366210
NCT00366210
Completed
Phase 1

Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors w/Plegic Hands

University of Alabama at Birmingham1 site in 1 country21 target enrollmentOctober 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Stroke Survivors With Plegic Hand
Sponsor
University of Alabama at Birmingham
Enrollment
21
Locations
1
Primary Endpoint
Motor Activity Log
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to compare modified CI therapy for strokes survivors with very limited function to an alternative package of conventional physical rehabilitation techniques

Detailed Description

Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, based on behavioral neuroscience studies of deafferented monkeys, that has been shown in controlled studies to produce large improvements in real-world upper-extremity use in individuals with chronic stroke. Up till now, survivors of stroke with plegic hands have been excluded from CI therapy protocols, whether on a research or clinical basis. Such individuals are estimated to make up at least 35% of the population with chronic stroke with residual motor deficit. Furthermore, there are no other interventions for such individuals that have controlled evidence of efficacy for increasing real-world function. Thus, these stroke survivors represent a large number of healthcare consumers with limited treatment options. We recently completed a pilot study of a modified form of CI therapy for stroke survivors with plegic hands, and obtained surprisingly positive findings. Six individuals were enrolled who had a flicker of active movement at the elbow and at the wrist or a finger and 30° of active range of motion at the shoulder. Participants received three weeks of CI therapy, combined with other modes of therapy, for six hours per day. The treatment package included tone management/movement facilitation, training of more-impaired arm use using shaping, functional task practice, restraint of the less-impaired arm in the laboratory and at home as indicated, and a package of behavioral methods for transferring gains from the laboratory to the home situation. As a group, the patients showed a large improvement in more-impaired arm use in daily life after treatment (Motor Activity Log or MAL; p's \< 05, Effect Size \> 1.5). Improvements in more-impaired arm motor ability, as measured by scores on a laboratory motor performance test (graded Wolf Motor Function Test; gWMFT) and standardized clinical examination (Fugl-Meyer), were also substantial (p's \< .05). Based on these initial findings, we propose a randomized, controlled clinical trial to rigorously test the efficacy of this modification of CI therapy for rehabilitating arm function in chronic stroke patients with severe upper-extremity impairment. To this end, 40 survivors of stroke with plegic hands will be randomly assigned to receive the intervention described above or a placebo control procedure of the same duration. Control participants will receive either 1) tone management, EMG biofeedback and other procedures in alternating blocks for 6 hr daily for 15 consecutive weekdays or 2) usual \& customary care. Measures of arm motor ability (gWMFT; Fugl-Meyer), arm use in daily life (MAL, accelerometry), and quality of life (Stroke Impact Scale) will be administered to all participants before and after treatment and at long-term. If the modified CI therapy participants shows larger improvements in more-impaired arm function than the control group participants, this will suggest it is an efficacious treatment and raise hopes of additional recovery for a large group of healthcare consumers with limited treatment options.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
September 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 1a. The ability to initiate extension against gravity at the wrist or at least one digit and initiate extension and flexion at the elbow.
  • 1b. No active movement required for the wrist, fingers or thumb. At least 20° active extension required at elbow.
  • Actively move the shoulder at least 30 degrees in flexion, abduction, or scaption
  • Score less than 4 on the Modified Ashworth Scale for all impaired joints
  • Passive range of motion criteria \> or equal to 90° shoulder flexion, \> or equal to 90° shoulder abduction, \> or equal to 45° shoulder external rotation, \< or equal to 30° short of normal elbow extension, forearm supination to at least neutral, forearm pronation 45° or more from neutral, \< equal to 35° short of normal wrist extension, and \< equal to 35° short of normal metacarpophalangeal extension on all the digits.
  • Other Exclusion Criteria. Among the principal exclusion criteria are:
  • Less than 6 months post-stroke.
  • Motor problems that are not primarily unilateral.
  • Other neurological or musculoskeletal conditions, including excessive pain, affecting UE function.
  • Insufficient stamina or serious uncontrolled medical problems.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Motor Activity Log

Time Frame: Pre-treatment, Post-treatment, followup

Study Sites (1)

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