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

Primary Purpose

Chronic Stroke Survivors With Plegic Hand

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Constraint-Induced Movement (CI) Therapy
Stretching, Relaxation, & Biofeedback
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke Survivors With Plegic Hand focused on measuring stroke, rehabilitation, physical therapy, occupational therapy, arm

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Expanded CI therapy

Placebo Control

Usual & Customary Care Control

Arm Description

3.5 hours of training for the more-affected arm set in the laboratory for 15 consecutive weekdays

Stretching, movement exercises, and EMG biofeedback for the same duration as the experimental intervention.

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.

Outcomes

Primary Outcome Measures

Motor Activity Log

Secondary Outcome Measures

Full Information

First Posted
August 18, 2006
Last Updated
December 24, 2014
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00366210
Brief Title
Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors w/Plegic Hands
Official Title
Constraint-Induced Therapy Modified for Rehabilitating Arm Function in Stroke Survivors w/Plegic Hands
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke Survivors With Plegic Hand
Keywords
stroke, rehabilitation, physical therapy, occupational therapy, arm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expanded CI therapy
Arm Type
Experimental
Arm Description
3.5 hours of training for the more-affected arm set in the laboratory for 15 consecutive weekdays
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Stretching, movement exercises, and EMG biofeedback for the same duration as the experimental intervention.
Arm Title
Usual & Customary Care Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Constraint-Induced Movement (CI) Therapy
Intervention Type
Behavioral
Intervention Name(s)
Stretching, Relaxation, & Biofeedback
Intervention Description
Passive stretching of both arms, EMG biofeedback for more-impaired arm
Primary Outcome Measure Information:
Title
Motor Activity Log
Time Frame
Pre-treatment, Post-treatment, followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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. 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: 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. Serious cognitive deficits including inadequate ability to follow test instructions. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitendra Uswatte, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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

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