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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00041-56 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Saint-Etienne Métropole | UNKNOWN |
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Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view.
A new computerized Mirror Therapy (TM) device (Intensive Visual Simulation 3 (IVS3), Dessintey) which aims to solve the TM compliance problems and make it more efficient have been developed.
The aim of this study is to compare the observance and efficiency of the Intensive Visual Simulation 3 (IVS3) therapy as compared to traditional Mirror Therapy (TM) in a population of hemiplegic stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Patient with stroke ischemic or hemorrhagic will be included. They will have visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device and electroencephalography (EEG). |
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| Control group | Active Comparator | Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Visual Simulation 3 (IVS3) device | Device | Visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device will be realized and consist of 5 sessions per week for 4 weeks (20 minutes). The patient looks on a screen in front of him, mirroring the movements made by his healthy hand, while attempting to perform the same movement with his paretic hand. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days | Measured by Fugl-Meyer motor assessment score at baseline, at 18 days, at 32 days, and at 60 days. Fugl-Meyer score assesses the analytical motor skills of the upper limb with minimum score at 0 (hemiplegia) and maximum score at 66 (normal motor performance). | Day: 0, 18, 32, 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days. | Measured by Frenchay Arm Test score at baseline, at 18 days, at 32 days, and at 60 days. Frenchay Arm Test score assesses functional improvement of the activities of the upper limb paretics with minimum score at 0 (total dependence) and maximum score at 100 (complete autonomy). | Day: 0, 18, 32, 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal GIRAUX, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | France |
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| traditional Mirror Therapy (TM) | Device | Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes). |
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| Electroencephalography (EEG) | Device | Electroencephalography (EEG) will be performed during the 1st, 6th, 11th, 16th and 20th session of their programme will be made in order to evaluate brain activity. |
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| Change from baseline Barthel index at 18 days, at 32 days, and at 60 days. | Measured by Barthel index at baseline, at 18 days, at 32 days, and at 60 days. Barthel index assesses autonomy with minimum score at 0 (total dependence) and maximum score at 100 (complete autonomy). | Day: 0, 18, 32, 60 |
| Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days. | Measured by Abilhand questionnaire at baseline, at 18 days, at 32 days, and at 60 days. Abilhand questionnaire will allow self-evaluation of the function of the upper limb in daily life with minimum score at 0 (difficulties in daily life) and maximum score at 46 (no difficulties in daily life). | Day: 0, 18, 32, 60 |
| Analysis of brain activity | Measured by Electroencephalography (EEG) results. | Month: 2 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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