Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke
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|ClinicalTrials.gov Identifier: NCT01655160|
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : June 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 Start Date :||August 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655160
|Chang Gung Memorial Hospital|
|Kwei-shan, Toayuan county, Taiwan|
|Principal Investigator:||Ching-yi Wu, ScD||Chang Gung University|