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Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

This study is currently recruiting participants. (see Contacts and Locations)
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

January 30, 2012
February 27, 2013
January 2012
March 2013   (final data collection date for primary outcome measure)
  • 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.
Kinamatic analysis of arm movements [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01523925 on ClinicalTrials.gov Archive Site
  • 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.
Clinical assessment [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
Fugl-Meyer Assessment (FMA), Medical Research Council scale (MRC), Modified Ashworth Scale (MAS), MYOTON-3, Motor Activity Log, ABILHAND Questionnaire, Reintegration to Normal Living Index (RNL)
Not Provided
Not Provided
 
Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cerebrovascular Accident
  • 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: 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: 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
  • Behavioral: Functional electrical stimulation
    Other Name: FES
  • Experimental: Combined dCIT with FET
    Combined distributed constraint induced therapy with functional electrical therapy
    Interventions:
    • Behavioral: dCIT
    • Behavioral: Functional electrical stimulation
  • Experimental: Combined BAT with FET
    Combined bilateral arm treatment with functional electrical therapy
    Interventions:
    • Behavioral: BAT
    • Behavioral: Functional electrical stimulation
  • Active Comparator: Control intervention group
    Control intervention
    Intervention: Behavioral: Control intervention group
  • Experimental: dCIT
    distributed constraint induced therapy
    Intervention: Behavioral: dCIT
  • Experimental: BAT
    bilateral arm treatment
    Intervention: Behavioral: BAT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ching-yi Wu, ScD 886-3-2118800 ext 5761 cywu@mail.cgu.edu.tw
Taiwan
 
NCT01523925
NSC 99-2314-B-182-014-MY3, 98-3827B
No
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
  • National Science Council, Taiwan
  • National Health Research Institutes, Taiwan
Principal Investigator: Ching-yi Wu, ScD Chang Gung University
Chang Gung Memorial Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP