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

NCT00366210 | Completed Phase 1 DMC

• 1 other identifier: F060112013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Stroke Survivors With Plegic Hand

Keywords

stroke; rehabilitation; physical therapy; occupational therapy; arm

Outcome Measures

Primary Outcomes (1)

• Motor Activity Log

  Pre-treatment, Post-treatment, followup

Study Arms (3)

Expanded CI therapy

EXPERIMENTAL

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 Control

PLACEBO COMPARATOR

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

Behavioral: Stretching, Relaxation, & Biofeedback

Usual & Customary Care Control

NO 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.

Interventions

Constraint-Induced Movement (CI) Therapy BEHAVIORAL

Expanded CI therapy

Stretching, Relaxation, & Biofeedback BEHAVIORAL

Passive stretching of both arms, EMG biofeedback for more-impaired arm

Placebo Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. The ability to initiate extension against gravity at the wrist or at least one digit and initiate extension and flexion at the elbow.
• b. 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Therapeutics; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Gitendra Uswatte, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 21, 2006
• Study Start: October 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 25, 2014

Record last verified: 2010-08

Locations

US (1)