Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. (SI-VIM)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Stroke

Treatments: Device: Intensive Visual Simulation 3 (IVS3) device; Device: Electroencephalography (EEG); Device: traditional Mirror Therapy (TM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04025411

2019-A00041-56 (Other Identifier)

18CH200

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First ischemic or hemorrhagic stroke for less than one year
• 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

• Patient who have not Magnetic Resonance Images (MRI) of the brain during stroke
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Experimental group

Experimental group

Description:

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).

Treatment:

Device: Electroencephalography (EEG)

Device: Intensive Visual Simulation 3 (IVS3) device

Control group

Active Comparator group

Description:

Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG).

Treatment:

Device: Electroencephalography (EEG)

Device: traditional Mirror Therapy (TM)