Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke

Study Overview
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Brief Summary
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After stroke, patients frequently suffer from arm or hand weakness. There are numerous rehabilitation methods to stimulate recovery, amongst which mirror therapy (MT). It is particularly interesting in cases for which impairment is severe, as many other forms of therapy are often impossible. During MT, a mirror is placed in the midsagittal plane, so as to hide the impaired limb. Thereafter, the subject is asked to move his unimpaired limb while looking at its reflection in the mirror, thereby creating the illusion that the contralateral, impaired limb is moving. The objective of this study is to better determine the efficacy of MT. The investigators will therefore compare recovery of arm function in two groups of patient, that perform a regimen of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional therapy. One group performs MT and the other one performs a therapy in which the same movements are performed, but without the use of a mirror, with unrestricted view of both limbs. Allocation to each group will be randomized. Arm function will be evaluated by use of a scale before, during and after the 4 week period. The assessor for the primary outcome measure will not know in which group the patient is. There will be a total of 30 patients included over a one year study period.

Official Title
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Mirror Therapy: Effects on Functional Recuperation of Severe Upper Limb Paresis After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Mirror Therapy
* Other: Control Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or hemorrhagic stroke, diagnosed clinically and by imagery, more than one month after onset; Severe upper limb paresis with Upper-Extremity Fugl-Meyer Score < 19/60 . Exclusion Criteria: Significant limitation in upper limb function predating the recent stroke, caused by former symptomatic stroke and/or an orthopedic/rheumatologic disease; Neuropsychologic or psychiatric impairment with significant interference with participation in therapy; Severe visual impairment.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirror Therapy (MT)<br>Standard therapy + 30 min/day of mirror therapy, 5 days/week, for 4 weeks, administered by experienced physical and occupational therapists. | Other: Mirror Therapy<br>* Mirror therapy will consist in placing a large mirror in the sagittal plane of the subject so as to reflect his healthy arm while hiding the paretic one, and then asking him to perform movements of his healthy arm while looking at its reflection in the mirror.<br>|
| Active Comparator: Control Therapy (CT)<br>Standard therapy + 30 min/day of CT. | Other: Control Therapy<br>* Performance of the same movements as the experimental group without the mirror or instructions as to where to look, 5 days/week, for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl Meyer Assessment - Upper Limb (FMA-UE) | Change in Fugl Meyer Assessment - Upper Limb (FMA-UE) at different time points: before, during, after intervention and after a 6 week follow-up. | Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Independence Measure (FIM) | Change in Functional Independence Measure (FIM) at different time points: before, during, after intervention and after a 6 week follow-up. | Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation. | 
| Change in Bell cancellation task | Change in Bell cancellation task at different time points: before, during, after intervention and after a 6 week follow-up. | Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation. | 
| Change in Line bisection task | Change in Line bisection task at different time points: before, during, after intervention and after a 6 week follow-up. | Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation. | 
| Change in Numeric pain scale | Change in Numeric pain scale at different time points: before, during, after intervention and after a 6 week follow-up. | Baseline, 2 weeks and 4 weeks after start of therapy. Additional follow-up visit min. 6 weeks after discharge from rehabilitation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, mirror therapy, neurorehabilitation