Mirror Box Imaging Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of mirror box therapy on upper extremity, motor recovery and motor functioning in patients that have suffered a stroke.

Detailed Description
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Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors, with 30%-60% of patients being unable to fully recover functional use of their upper limbs. As recovery may be due to insufficient or inadequate therapeutic interventions, the progress and evaluation of upper limb treatment is currently being investigated. Mirror Box therapy is a task orientated, non-invasive, economic and patient directed therapy for hemiparetic upper limb post stroke patients. The study is intended to evaluate cerebral reorganization by using mirror therapy. Movements of the stronger limb trick the brain into thinking that the weaker arm is moving and to stimulate the respective brain areas. Patients are enrolled into two groups using standard upper limb rehabilitation for three weeks followed by standard rehabilitation plus Mirror Box for another three weeks (Group 1). Group 2 will receive the same therapy in inverted order. Patients will receive clinical and functional assessment at baseline, three weeks and six weeks including brain MRI using functional resting state MRI. The primary outcome is functional connectivity (correlation coefficient) at baseline and after treatment. Secondary endpoints include motor and functional recovery using outcome measures like Fugl Meyer assessment, Action Research Arm Test, grip and pincer strength. Further secondary endpoints are increase in sensorimotor cortex activation across the period of therapy and cortical reorganization.

Official Title
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Effects of Mirror Box Therapy on Neuroplasticity and Functional Outcome in Hemiparetic Upper Limb Post Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Mirror Box therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18yrs to 105yrs Hemiparetic upper limb post stroke Capable of providing informed consent Intact vision: if diagnosis of peripheral field defect, patient should be able to compensate for it. Exclusion Criteria: Any contraindication to MRI scanning Clinically significant psychiatric disorder (e.g. depression) Pre-existing neurological or psychiatric disease that could confound the study results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirror box therapy<br>The participants in the mirror box therapy arm will receive mirror box therapy for 3 weeks for upper limb rehabilitation post stroke. | Other: Mirror Box therapy<br>* In mirror box therapy the patient uses the reflection of their good arm to trick to brain into thinking that the effected arm is working.<br>|
| No Intervention: Standard treatment group<br>The participants will receive the standard treatment arm for 3 weeks for upper limb rehabilitation post stroke. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain connectivity will be assessed by resting-state fMRI |  | Baseline, 3 weeks and at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of daily living will be assessed with Barthel index. |  | Baseline, 3 weeks and at 6 weeks | 
| Function of the affected hemiplegic upper limb will be assessed with action research arm test |  | Baseline, 3 weeks and at 6 weeks | 
| Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test. |  | Baseline, 3 weeks and at 6 weeks | 
| Grip strength will be assessed using hand dynamometer |  | Baseline, 3 weeks and at 6 weeks |