Clinical trial NCT01523925: Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
Official title: Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Functional electrical therapy
Bilateral arm training
Constraint induced therapy
Stroke rehabilitation
Clinical evaluation
Kinematic analysis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2012-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Movement time (MT)
timeFrame: Baseline and change from baseline in MT at 4 weeks
measure: Total displacement (TD)
timeFrame: Baseline and change from baseline in TD at 4 weeks
measure: Percentage of peak velocity (PPV)
timeFrame: Baseline and change from baseline in PPV at 4 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
measure: Medical Research Council scale (MRC)
timeFrame: Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks
measure: MYOTON-3
timeFrame: Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks
measure: Motor Activity Log (MAL)
timeFrame: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
measure: ABILHAND Questionnaire
timeFrame: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
measure: Reintegration of Normal Living Index (RNL)
timeFrame: Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks
Other outcomes:
Locations:
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: