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Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
MT with low-intensity group (MT-LI)
MT with moderate-intensity group
Mirror therapy with high intensity group
Control intervention group
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 Stroke rehabilitation, Mirror therapy, Functional performance, Kinematic analysis, Functional magnetic resonance image, Motor recovery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • first episode of stroke in cortical regions
  • time since stroke less than 3 months
  • initial motor part of UE of FMA score ranging from 24 to 52
  • no serious cognitive impairment

Exclusion Criteria:

  • aphasia
  • visual impairments
  • major health problems or poor physical conditions
  • currently participation in any other

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mirror therapy treatment

control intervention group

Arm Description

Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)

The part of this project will involve 1 treatment groups:control intervention group (CI)

Outcomes

Primary 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.
Action Research Arm Test (ARAT)
ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).
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.
Adelaide Activities Profile (AAP)
AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.

Secondary Outcome Measures

Functional magnetic resonance imaging (fMRI)
uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.
Physiological marker measures
measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.

Full Information

First Posted
July 30, 2012
Last Updated
June 4, 2015
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01655160
Brief Title
Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke
Official Title
Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke: Outcomes in Brain and Movement Reorganization, Sensorimotor and Daily Functions, and Measures of Physiological Markers.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.
Detailed Description
This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke rehabilitation, Mirror therapy, Functional performance, Kinematic analysis, Functional magnetic resonance image, Motor recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mirror therapy treatment
Arm Type
Experimental
Arm Description
Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)
Arm Title
control intervention group
Arm Type
Active Comparator
Arm Description
The part of this project will involve 1 treatment groups:control intervention group (CI)
Intervention Type
Behavioral
Intervention Name(s)
MT with low-intensity group (MT-LI)
Other Intervention Name(s)
MT-LI
Intervention Description
The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.
Intervention Type
Behavioral
Intervention Name(s)
MT with moderate-intensity group
Other Intervention Name(s)
MT-MI
Intervention Description
The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.
Intervention Type
Behavioral
Intervention Name(s)
Mirror therapy with high intensity group
Other Intervention Name(s)
MT-HI
Intervention Description
The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training
Intervention Type
Behavioral
Intervention Name(s)
Control intervention group
Other Intervention Name(s)
CI
Intervention Description
The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.
Primary 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
Action Research Arm Test (ARAT)
Description
ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).
Time Frame
Baseline, change of ARAT at 2 weeks, and change of ARAT 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
Adelaide Activities Profile (AAP)
Description
AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.
Time Frame
Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks
Secondary Outcome Measure Information:
Title
Functional magnetic resonance imaging (fMRI)
Description
uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.
Time Frame
Baseline and change of fMRI at 4 weeks
Title
Physiological marker measures
Description
measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.
Time Frame
Baseline and change from baseline in physiological marker measures at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first episode of stroke in cortical regions time since stroke less than 3 months initial motor part of UE of FMA score ranging from 24 to 52 no serious cognitive impairment Exclusion Criteria: aphasia visual impairments major health problems or poor physical conditions currently participation in any other
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
Kwei-shan
State/Province
Toayuan county
Country
Taiwan

12. IPD Sharing Statement

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Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke

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