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

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ClinicalTrials.gov Identifier: NCT00366210
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham

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

Condition or disease Intervention/treatment Phase
Chronic Stroke Survivors With Plegic Hand Behavioral: Constraint-Induced Movement (CI) Therapy Behavioral: Stretching, Relaxation, & Biofeedback Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors w/Plegic Hands
Study Start Date : October 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: Expanded CI therapy
3.5 hours of training for the more-affected arm set in the laboratory for 15 consecutive weekdays
Behavioral: Constraint-Induced Movement (CI) Therapy
Placebo Comparator: Placebo Control
Stretching, movement exercises, and EMG biofeedback for the same duration as the experimental intervention.
Behavioral: Stretching, Relaxation, & Biofeedback
Passive stretching of both arms, EMG biofeedback for more-impaired arm

No Intervention: Usual & Customary Care Control
Treatments available to participants as part of their regular medical care, such as conventional physical or occupational therapy. For some participants, this would involve no treatment, since all participants were more than one year post stroke.f standard clinical care.



Primary Outcome Measures :
  1. Motor Activity Log [ Time Frame: Pre-treatment, Post-treatment, followup ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366210


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Gitendra Uswatte, PhD University of Alabama at Birmingham

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00366210     History of Changes
Other Study ID Numbers: F060112013
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: August 2010

Keywords provided by University of Alabama at Birmingham:
stroke
rehabilitation
physical therapy
occupational therapy
arm

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