Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebrovascular Accident |
Behavioral: dCIT Behavioral: BAT Behavioral: Control intervention group Behavioral: Functional electrical stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration |
- Movement time (MT) [ Time Frame: Baseline and change from baseline in MT at 4 weeks ] [ Designated as safety issue: No ]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.
- Total displacement (TD) [ Time Frame: Baseline and change from baseline in TD at 4 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Fugl-Meyer Assessment (FMA) [ Time Frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks ] [ Designated as safety issue: No ]The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
- Medical Research Council scale (MRC) [ Time Frame: Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks ] [ Designated as safety issue: No ]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).
- Modified Ashworth Scale (MAS) [ Time Frame: Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks ] [ Designated as safety issue: No ]The MAS scale is an ordinal scale (0-5 points) assessing spasticity of skeletal muscle in UE. A higher score indicating more spasticity.
- MYOTON-3 [ Time Frame: Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks ] [ Designated as safety issue: No ]Assessment of the functional state of skeletal muscle was carried out using myometric measurements with the MYOTON-3 device.
- Motor Activity Log (MAL) [ Time Frame: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks ] [ Designated as safety issue: No ]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.
- ABILHAND Questionnaire [ Time Frame: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks ] [ Designated as safety issue: No ]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.
- Reintegration of Normal Living Index (RNL) [ Time Frame: Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combined dCIT with FET
Combined distributed constraint induced therapy with functional electrical therapy
|
Behavioral: dCIT
This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities.
Other Name: distributed constraint induced therapy
Behavioral: Functional electrical stimulation
Other Name: FES
|
|
Experimental: Combined BAT with FET
Combined bilateral arm treatment with functional electrical therapy
|
Behavioral: BAT
The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
Other Name: bilateral arm training
Behavioral: Functional electrical stimulation
Other Name: FES
|
|
Active Comparator: Control intervention group
Control intervention
|
Behavioral: Control intervention group
The conventional intervention group is designed to control for the duration and intensity of patient-therapist interactions and therapeutic activities (1.5 hours/day, 5 days/week, for 4 weeks). Therapy in the control intervention group will involve training for coordination, balance, and movements of the affected upper extremity, as well as compensatory practice on functional tasks with the unaffected upper extremity or both upper extremities.
Other Name: Control intervention
|
|
Experimental: dCIT
distributed constraint induced therapy
|
Behavioral: dCIT
This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities.
Other Name: distributed constraint induced therapy
|
|
Experimental: BAT
bilateral arm treatment
|
Behavioral: BAT
The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
Other Name: bilateral arm 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Ching-yi Wu, ScD | 886-3-2118800 ext 5761 | cywu@mail.cgu.edu.tw |
| Taiwan | |
| Chang Gung Memorial Hospital | Recruiting |
| Taoyuan County, Taiwan | |
| Contact: Chia-ling Chen, MD/PhD 886-3-3281200 ext 8148 ccl1374@adm.cgmh.com.tw | |
| Principal Investigator: | Ching-yi Wu, ScD | Chang Gung University |
More Information
No publications provided
| Responsible Party: | Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01523925 History of Changes |
| Other Study ID Numbers: | NSC 99-2314-B-182-014-MY3, 98-3827B |
| Study First Received: | January 30, 2012 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Chang Gung Memorial Hospital:
|
Functional electrical therapy Bilateral arm training Constraint induced therapy |
Stroke rehabilitation Clinical evaluation Kinematic analysis |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013