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

Chronic Stroke Survivors With Plegic Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366210
• Other study ID #: F060112013
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 18, 2006
• Last updated: December 24, 2014
• Start date: October 2005
• Est. completion date: September 2009

Study information

• Verified date: August 2010
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

2. Actively move the shoulder at least 30 degrees in flexion, abduction, or scaption 3. Score less than 4 on the Modified Ashworth Scale for all impaired joints 4. 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:

1. Less than 6 months post-stroke.

2. Motor problems that are not primarily unilateral.

3. Other neurological or musculoskeletal conditions, including excessive pain, affecting UE function.

4. Insufficient stamina or serious uncontrolled medical problems.

5. Serious cognitive deficits including inadequate ability to follow test instructions.

6. Less than 19 years old. Grade 4 MMC for wrist, thumb, fingers; i.e., individuals who can actively extend the wrist > or equal to 10°, abduct the thumb or equal to 10°, and initiate extension of at least two additional digits will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Stroke Survivors With Plegic Hand
• Stroke

Intervention

Behavioral:
• Constraint-Induced Movement (CI) Therapy

• Stretching, Relaxation, & Biofeedback
Passive stretching of both arms, EMG biofeedback for more-impaired arm

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Activity Log		Pre-treatment, Post-treatment, followup	No