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Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

Primary Purpose

Cerebrovascular Accident

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
dCIT
BAT
Control intervention group
Functional electrical stimulation
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Functional electrical therapy, Bilateral arm training, Constraint induced therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Combined dCIT with FET

Combined BAT with FET

Control intervention group

dCIT

BAT

Arm Description

Combined distributed constraint induced therapy with functional electrical therapy

Combined bilateral arm treatment with functional electrical therapy

Control intervention

distributed constraint induced therapy

bilateral arm treatment

Outcomes

Primary Outcome Measures

Movement time (MT)
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)
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)
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)
The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
Medical Research Council scale (MRC)
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)
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
Assessment of the functional state of skeletal muscle was carried out using myometric measurements with the MYOTON-3 device.
Motor Activity Log (MAL)
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
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)
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.

Full Information

First Posted
January 30, 2012
Last Updated
February 10, 2015
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01523925
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Functional electrical therapy, Bilateral arm training, Constraint induced therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined dCIT with FET
Arm Type
Experimental
Arm Description
Combined distributed constraint induced therapy with functional electrical therapy
Arm Title
Combined BAT with FET
Arm Type
Experimental
Arm Description
Combined bilateral arm treatment with functional electrical therapy
Arm Title
Control intervention group
Arm Type
Active Comparator
Arm Description
Control intervention
Arm Title
dCIT
Arm Type
Experimental
Arm Description
distributed constraint induced therapy
Arm Title
BAT
Arm Type
Experimental
Arm Description
bilateral arm treatment
Intervention Type
Behavioral
Intervention Name(s)
dCIT
Other Intervention Name(s)
distributed constraint induced therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BAT
Other Intervention Name(s)
bilateral arm training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control intervention group
Other Intervention Name(s)
Control intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Functional electrical stimulation
Other Intervention Name(s)
FES
Primary Outcome Measure Information:
Title
Movement time (MT)
Description
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.
Time Frame
Baseline and change from baseline in MT at 4 weeks
Title
Total displacement (TD)
Description
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.
Time Frame
Baseline and change from baseline in TD at 4 weeks
Title
Percentage of peak velocity (PPV)
Description
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.
Time Frame
Baseline and change from baseline in PPV at 4 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
Time Frame
Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
Title
Medical Research Council scale (MRC)
Description
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).
Time Frame
Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks
Title
Modified Ashworth Scale (MAS)
Description
The MAS scale is an ordinal scale (0-5 points) assessing spasticity of skeletal muscle in UE. A higher score indicating more spasticity.
Time Frame
Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks
Title
MYOTON-3
Description
Assessment of the functional state of skeletal muscle was carried out using myometric measurements with the MYOTON-3 device.
Time Frame
Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks
Title
Motor Activity Log (MAL)
Description
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.
Time Frame
Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
Title
ABILHAND Questionnaire
Description
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.
Time Frame
Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
Title
Reintegration of Normal Living Index (RNL)
Description
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.
Time Frame
Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-yi Wu, ScD
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan County
Country
Taiwan

12. IPD Sharing Statement

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Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation

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