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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014