The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function of Stroke at Acute Stage.

Study Overview
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Brief Summary
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Objective: To comparing the effects of unilateral and bilateral mirror therapy on upper extremity function of stroke at acute stage. We hypothesize there are different effects between unilateral and bilateral mirror therapy on stroke patients at acute stage. Method: Patients with unilateral stroke and the onset within one month will be recruited and then randomly allocated to one of the three groups (including unilateral mirror therapy, bilateral mirror therapy, and conventional occupational therapy). Patient will receive 20 consecutive sessions of intervention (5 time per week, totally 4 weeks) and assessments before and after the intervention within one week. In each intervention session, patients will receive 30 minutes unilateral or bilateral mirror therapy depending on their allocated groups and then 30 conventional occupational therapy. The patients recruited in the conventional occupational therapy group will receive 60 minute conventional therapy. The outcome measures at pre- and post-treatment will including the Fugl-Meyer Assessment for upper extremity (FMA-UE), the Modified Ashworth Scale (MAS), the Jamar Hydraulic Hand Dynamometer, the Chedoke Arm and Hand Activity Inventory (CAHAI), the Revised Nottingham Sensory Assessment (rNSA), and Functional Independence Measurement (FIM).

Official Title
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The Effects of Unilateral and Bilateral Mirror Therapy on Upper Extremity Function of Stroke at Acute Stage: A Pilot Randomized Controlled Trial.

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: unilateral and bilateral mirror therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral stroke onset within 1 month The score of Mini-Mental State Examination (MMSE) is more than 24 The score of Fugl-Meyer Assessment for upper extremity (FMA-UE) is between 18 to 56 The score of Modified Ashworth Scale (MAS) is less than 3 Willing to receive 3-5 sessions of the intervention per week, total 20 sessions consecutively Willing to sign informed consent Exclusion Criteria: Unstable vital sign or complicating with other symptoms of neurological disease Auditory or visual function impairment Complicating with perceptual impairment (e.g., apraxia, neglect, or visual agnosia) Receiving botulinum toxin injection within 3 months Complicating with Wernicke's or Broca's aphasia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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
Interventional Model Description: Patients with unilateral stroke and the onset within one month will be recruited and then randomly allocated to one of the three groups (including unilateral mirror therapy, bilateral mirror therapy, and conventional occupational therapy).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unilateral mirror therapy (UMT)<br>Participants will receive 30 minutes unilateral mirror therapy and then 30 minutes conventional occupational therapy in each treatment session. there will be 20 consecutive sessions (5 times per week, lasting 4 weeks totally) | Other: unilateral and bilateral mirror therapy<br>* The mirror box is placed on a table in the sagittal plane of the participant. The affected upper extremity of the participant is hidden in the morror box and the unaffected upper extremity is placed symmetrically. During the unilateral or bilateral mirror therapy, the participant is requested to execute a serial of movements and tasks and pay attention on observing the reflection of the unaffected side in the mirror simultaneously. In the bilateral mirror therapy, the participant also has to move the affected upper extremity simultaneously; while in the unilateral mirror therapy, the participant only keeps the affected side relaxed.<br>|
| Experimental: Bilateral Mirror Therapy (BMT)<br>Participants will receive 30 minutes bilateral mirror therapy and then 30 minutes conventional occupational therapy in each treatment session. there will be 20 consecutive sessions (5 times per week, lasting 4 weeks totally) | Other: unilateral and bilateral mirror therapy<br>* The mirror box is placed on a table in the sagittal plane of the participant. The affected upper extremity of the participant is hidden in the morror box and the unaffected upper extremity is placed symmetrically. During the unilateral or bilateral mirror therapy, the participant is requested to execute a serial of movements and tasks and pay attention on observing the reflection of the unaffected side in the mirror simultaneously. In the bilateral mirror therapy, the participant also has to move the affected upper extremity simultaneously; while in the unilateral mirror therapy, the participant only keeps the affected side relaxed.<br>|
| Placebo Comparator: Conventional Occupational Therapy (COT)<br>Participants will receive 60 minutes conventional occupational therapy in each treatment session. there will be 20 consecutive sessions (5 times per week, lasting 4 weeks totally) | Other: unilateral and bilateral mirror therapy<br>* The mirror box is placed on a table in the sagittal plane of the participant. The affected upper extremity of the participant is hidden in the morror box and the unaffected upper extremity is placed symmetrically. During the unilateral or bilateral mirror therapy, the participant is requested to execute a serial of movements and tasks and pay attention on observing the reflection of the unaffected side in the mirror simultaneously. In the bilateral mirror therapy, the participant also has to move the affected upper extremity simultaneously; while in the unilateral mirror therapy, the participant only keeps the affected side relaxed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment for upper extremity (FMA-UE) | The FMA-UE is a commonly used assessment in clinical for the extent of motor impairment of upper extremity post-stroke. The score ranged from 0 to 66. The psychometric properties of the FMA-UE had established, and there was also good responsiveness in the past studies. | pre-treatment: before intervention within a week; post-treatment: after intervention within a week | 
| The Jamar Hydraulic Hand Dynamometer | The Jamar Hydraulic Hand Dynamometer is a gold standard assessment tool for measuring muscle power including the grip strength, palmar pinch, and lateral pinch. | pre-treatment: before intervention within a week; post-treatment: after intervention within a week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale (MAS) | The MAS is a clinical measurement for muscle spasticity. The score is ranged from 0 to 4. The shoulder, elbow, forearm, wrist, and fingers will be assessed. The psychometric properties of the MAS had established in the past studies. | pre-treatment: before intervention within a week; post-treatment: after intervention within a week | 
| Chedoke Arm and Hand Activity Inventory (CAHAI) | The CAHAI is used for the involvement of the impairment upper extremity during the bimanual tasks. There are 13 item and each score is ranged from 1-7. The psychometric properties of the CAHAI had established in the past studies. | pre-treatment: before intervention within a week; post-treatment: after intervention within a week | 
| Functional Independence Measurement (FIM) | The FIM was applied for evaluating the independent level and ADL function of the stroke patients. It includes 18 items of self-care, sphincter control, transfers, locomotion, communication, and social cognition. Score of each item is ranged from 1 to 7. The psychometric properties of the FIM had established in the past studies. | pre-treatment: before intervention within a week; post-treatment: after intervention within a week | 
| Revised Nottingham Sensory Assessment (rNSA) | The rNSA is developed for assessing sensory function of patients with stroke. The reliability of rNSA was established in the past study. | pre-treatment: before intervention within a week; post-treatment: after intervention within a week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute stage, Stroke, unilateral mirror therapy, bilateral mirror therapy, motor function of upper extremity