Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.
NCT ID: NCT04025411
Last Updated: 2024-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2019-10-28
2023-07-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental group
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).
Intensive Visual Simulation 3 (IVS3) 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.
Electroencephalography (EEG)
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.
Control group
Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG).
traditional Mirror Therapy (TM)
Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
Electroencephalography (EEG)
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.
Interventions
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Intensive Visual Simulation 3 (IVS3) 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.
traditional Mirror Therapy (TM)
Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
Electroencephalography (EEG)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not having reoffend
* Responsible for an initially complete hemiplegia,
* Upper-limb deficiency with the modified Frenchay Score below 70,
* Not neurological history other than stroke,
* Having signed the written consent
* Affiliated or entitled to a social security scheme
Exclusion Criteria
* Having complete lesion of the primary motor cortex
* With an addiction to alcohol or drugs
* With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignancy, severe renal or pulmonary impairment
* History of associated disabling general disease
* With associated cerebellar syndrome
* With clinical involvement of the brainstem
* Pregnancy in progress
* Patients under the protection of justice.
18 Years
80 Years
ALL
No
Sponsors
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Saint-Etienne Métropole
UNKNOWN
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Pascal GIRAUX, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Chu Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2019-A00041-56
Identifier Type: OTHER
Identifier Source: secondary_id
18CH200
Identifier Type: -
Identifier Source: org_study_id
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