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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) | 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) | 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) | 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 | 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) | 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) | 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 | measure inflammatory markers, oxidative stress markers, and erythrocyte deformability. | Baseline and change from baseline in physiological marker measures at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke rehabilitation, Mirror therapy, Functional performance, Kinematic analysis, Functional magnetic resonance image, Motor recovery