Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebrovascular Accident
- Sponsor
- Chang Gung Memorial Hospital
- Locations
- 1
- Primary Endpoint
- Total displacement (TD)
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training.
Detailed Description
Two theory-based, task-oriented approaches are distributed CIT (dCIT) and robot-assisted Bilateral training(BAT). CIT/dCIT involves massed practice of the affected arm and restraint of the unaffected arm. BAT involves repetitive practice of symmetrical bilateral movements on robot. Both are evident to improve motor performance, motor control or daily function in high functioning patients. These dCIT and BAT have their own limitations for motor-deficit rehabilitation after stroke, i.e. only appropriate for high-functioning or mildly motor impaired patients. Functional electrical therapy, an innovative technology, is proposed as an adjunct to these behavioral approaches to assist in movement execution. Functional electrical therapy is used to increase the electric activity of muscles for movement and the active range of motion in low functioning patients. Combining functional electrical therapy into CIT or BAT may extend the utility of these two behavioral approaches beyond patients with mild motor deficits and could expedite the progress of motor recovery. This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with dCIT or with BAT.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The onset duration more than 6 months
- •An initial upper extremity subsection of the Fugl-Meyer Assessment score of 33 to 52 indicating moderate or moderate-to-mild movement impairment
- •No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- •The availability of caregiver for assistance during the 6-hour restraint time of unaffected extremity per day
- •No balance problems sufficient to compromise safety when wearing the project's constraint device with the assistance of the caregiver
- •Considerable nonuse of the affected upper extremity (an AOU score \< 2.5 of Motor Activity Log)
Exclusion Criteria
- •Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- •Excessive pain in any joint that might limit participation
Outcomes
Primary Outcomes
Total displacement (TD)
Time Frame: Baseline and change from baseline in TD at 4 weeks
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. TD refers to the path of a hand in three-dimensional space and is a measure of trajectory smoothness.
Percentage of peak velocity (PPV)
Time Frame: Baseline and change from baseline in PPV at 4 weeks
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. The PPV reflects the duration of the acceleration phase relative to the deceleration phase and indicates the type of movement strategy selected for a motor action.
Movement time (MT)
Time Frame: Baseline and change from baseline in MT at 4 weeks
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. MT is the interval between movement onset and offset.
Secondary Outcomes
- MYOTON-3(Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks)
- Modified Ashworth Scale (MAS)(Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks)
- Motor Activity Log (MAL)(Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks)
- Fugl-Meyer Assessment (FMA)(Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks)
- Medical Research Council scale (MRC)(Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks)
- Reintegration of Normal Living Index (RNL)(Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks)
- ABILHAND Questionnaire(Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks)