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

This study is currently recruiting participants.
Verified January 2014 by Chang Gung Memorial Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01655160
First received: July 30, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Cerebrovascular Accident
Behavioral: MT with low-intensity group (MT-LI)
Behavioral: MT with moderate-intensity group
Behavioral: Mirror therapy with high intensity group
Behavioral: Control intervention group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary 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.

  • Action Research Arm Test (ARAT) [ Time Frame: Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks ] [ Designated as safety issue: No ]
    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) [ 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.

  • Adelaide Activities Profile (AAP) [ Time Frame: Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and change of fMRI at 4 weeks ] [ Designated as safety issue: No ]
    uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.

  • Physiological marker measures [ Time Frame: Baseline and change from baseline in physiological marker measures at 4 weeks ] [ Designated as safety issue: No ]
    measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.


Estimated Enrollment: 128
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: CI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655160

Contacts
Contact: Ching-yi Wu, ScD +886-3-211-8800 ext 5761 cywu@mail.cgu.edu.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Kwei-shan, Toayuan county, Taiwan
Contact: Chia-ling Chen, MD/PhD    886-3-3281200 ext 8148      
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, 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: NCT01655160     History of Changes
Other Study ID Numbers: 100-4548B
Study First Received: July 30, 2012
Last Updated: January 29, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Stroke rehabilitation
Mirror therapy
Functional performance
Kinematic analysis
Functional magnetic resonance image
Motor recovery

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 17, 2014