Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Study Overview
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Brief Summary
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The investigators developed a real-time 2-axis mirror robot system as a simple add-on module for conventional mirror therapy using a closed feedback mechanism, which allows for real-time movement of the hemiplegic arm. The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training.

Detailed Description
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The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training. These tasks included more complicated tasks so that the participants would be interested in the tasks without the robot system. Before and after 10 sessions of the therapy, the investigators conduct functional evaluations: the Fugl-Meyer assessment scale of the upper extremity (FMA-UE), the modified Ashworth scale, the modified Barthel index of upper extremity (MBI-UE: personal hygiene, bathing, feeding, and dressing), and the Jebsen hand function test, hand power measurement, and hemispatial neglect test (line bisection test and Albert's test) with the same occupational therapist. The motor evoked potential was measured for the patients without the history of brain surgery or seizure. The investigators selected a thumb finding test (TFT) among various tools for assessing proprioception, because TFT is widely used and reliable. The TFT can be assessed, after confirming normal proprioception in the unaffected arm, by the patient touching the nose with their eyes closed while the examiner lifts the affected arm to eye level. The patient is then asked to grasp the thumb of the affected hand with the unaffected hand, and this is repeated. The examiner then places a hand over the patient's eyes and raises the patient's affected hand to well above the patient's head. The patient is then asked to grasp the thumb as before.

Official Title
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Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Conditions
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Stroke

Intervention / Treatment
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* Device: Robotic mirror therapy
* Device: Conventional mirror therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old Supratentorial stroke diagnosed between 4 months and 6 years ago Upper-limb hemiplegia with Medical Research Council grade 2 or less. Exclusion Criteria: Severe spasticity with modified Ashworth scale of grade 3 or more; Mini-mental state examination score less than 12 Global or sensory aphasia.

Ages Eligible for Study
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Minimum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic mirror therapy<br>For 30 min per day for two weeks (10 sessions) | Device: Robotic mirror therapy<br>* 2-dimensional<br>|
| Active Comparator: Conventional mirror therapy<br>For 30 min per day for two weeks (10 sessions) | Device: Conventional mirror therapy<br>* 2- and 3-dimensional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer assessment scale |  | Change from baseline data at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thumb finding test |  | Before treatment, after 2 weeks, after 2 months | 
| Modified Ashworth scale |  | Before treatment, after 2 weeks, after 2 months | 
| Modified Barthel index |  | Before treatment, after 2 weeks, after 2 months | 
| Hand power(lb) assessed by dynamometer |  | Before treatment, after 2 weeks, after 2 months | 
| Jebsen hand function test |  | Before treatment, after 2 weeks, after 2 months | 
| Hemispatial neglect test |  | Before treatment, after 2 weeks, after 2 months | 
| Functional brain MRI |  | Before treatment, after 2 weeks | 
| Fugl-Meyer assessment scale |  | after 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirror therapy, Proprioception, Rehabilitation, Stroke, Hemiplegia