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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Recruiting
CT.gov ID
NCT04025411
Collaborator
Saint-Etienne Métropole (Other)
34
Enrollment
1
Location
2
Arms
29.1
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Intensive Visual Simulation 3 (IVS3) device
  • Device: traditional Mirror Therapy (TM)
  • Device: Electroencephalography (EEG)
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study
Actual Study Start Date :
Oct 28, 2019
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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).

Device: 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.
Other Names:
  • Computerized Mirror Therapy (TM) device
  • Device: 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.

    Active Comparator: Control group

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

    Device: 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).

    Device: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days [Day: 0, 18, 32, 60]

      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).

    Secondary Outcome Measures

    1. Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days. [Day: 0, 18, 32, 60]

      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).

    2. Change from baseline Barthel index at 18 days, at 32 days, and at 60 days. [Day: 0, 18, 32, 60]

      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).

    3. Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days. [Day: 0, 18, 32, 60]

      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).

    4. Analysis of brain activity [Month: 2]

      Measured by Electroencephalography (EEG) results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Chu Saint-EtienneSaint-ÉtienneFrance

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Saint Etienne
    • Saint-Etienne Métropole

    Investigators

    • Principal Investigator: Pascal GIRAUX, MD PhD, CHU SAINT-ETIENNE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Saint Etienne
    ClinicalTrials.gov Identifier:
    NCT04025411
    Other Study ID Numbers:
    • 18CH200
    • 2019-A00041-56
    First Posted:
    Jul 18, 2019
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021