Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

This study is currently recruiting participants.
Verified February 2013 by Chang Gung Memorial Hospital
Sponsor:
Collaborators:
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01523925
First received: January 30, 2012
Last updated: February 27, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523925

Contacts
Contact: Ching-yi Wu, ScD 886-3-2118800 ext 5761 cywu@mail.cgu.edu.tw

Locations
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   
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Investigators
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 April 22, 2014