Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
- Conditions
- Cerebrovascular Accident
- Interventions
- Behavioral: BATBehavioral: dCITBehavioral: Control intervention groupBehavioral: Functional electrical stimulation
- Registration Number
- NCT01523925
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Combined BAT with FET Functional electrical stimulation Combined bilateral arm treatment with functional electrical therapy Combined BAT with FET BAT Combined bilateral arm treatment with functional electrical therapy BAT BAT bilateral arm treatment Combined dCIT with FET Functional electrical stimulation Combined distributed constraint induced therapy with functional electrical therapy Combined dCIT with FET dCIT Combined distributed constraint induced therapy with functional electrical therapy Control intervention group Control intervention group Control intervention dCIT dCIT distributed constraint induced therapy
- Primary Outcome Measures
Name Time Method Total displacement (TD) 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) 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) 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 Outcome Measures
Name Time Method MYOTON-3 Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks Assessment of the functional state of skeletal muscle was carried out using myometric measurements with the MYOTON-3 device.
Modified Ashworth Scale (MAS) Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks The MAS scale is an ordinal scale (0-5 points) assessing spasticity of skeletal muscle in UE. A higher score indicating more spasticity.
Motor Activity Log (MAL) Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate better performance.
Fugl-Meyer Assessment (FMA) Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
Medical Research Council scale (MRC) Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks The MRC scale examines the muscle strength of the affected arm and is reliable measurement with score ranged from 0 (no contraction) to 5 (normal power).
Reintegration of Normal Living Index (RNL) Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks The RNL is used to measure the satisfaction with community reintegration. It scores on a 4-point ordinal scale, with higher scores indicating a higher level of satisfaction.
ABILHAND Questionnaire Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan County, Taiwan