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

July 30, 2012
January 29, 2014
August 2012
July 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01655160 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Cerebrovascular Accident
  • 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
  • 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
  • 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)
    Interventions:
    • Behavioral: MT with low-intensity group (MT-LI)
    • Behavioral: MT with moderate-intensity group
    • Behavioral: Mirror therapy with high intensity group
  • Active Comparator: control intervention group
    The part of this project will involve 1 treatment groups:control intervention group (CI)
    Intervention: Behavioral: Control intervention group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Ching-yi Wu, ScD +886-3-211-8800 ext 5761 cywu@mail.cgu.edu.tw
Taiwan
 
NCT01655160
100-4548B
No
Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
National Science Council, Taiwan
Principal Investigator: Ching-yi Wu, ScD Chang Gung University
Chang Gung Memorial Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP