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

June 4, 2015 updated by: Chang Gung Memorial Hospital

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.

The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Toayuan county
      • Kwei-shan, Toayuan county, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mirror therapy treatment
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)
Behavioral: MT with low-intensity group (MT-LI)
The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.
Other Names:
  • MT-LI
Behavioral: MT with moderate-intensity group
The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.
Other Names:
  • MT-MI
Behavioral: Mirror therapy with high intensity group
The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training
Other Names:
  • MT-HI
Active Comparator: control intervention group
The part of this project will involve 1 treatment groups:control intervention group (CI)
Behavioral: Control intervention group
The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.
Other Names:
  • CI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment (FMA)
Time Frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
Action Research Arm Test (ARAT)
Time Frame: Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks
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).
Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks
Motor Activity Log (MAL)
Time Frame: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
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.
Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
ABILHAND Questionnaire
Time Frame: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
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.
Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
Adelaide Activities Profile (AAP)
Time Frame: Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks
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.
Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional magnetic resonance imaging (fMRI)
Time Frame: Baseline and change of fMRI at 4 weeks
uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.
Baseline and change of fMRI at 4 weeks
Physiological marker measures
Time Frame: Baseline and change from baseline in physiological marker measures at 4 weeks
measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.
Baseline and change from baseline in physiological marker measures at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Ching-yi Wu, ScD, Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-4548B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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