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Completed

NCT Number: NCT04025411

Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Computerized Mirror Therapy (TM) device

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).

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.

Primary outcomes

  1. Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days

    Time frame: 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 outcomes

  1. Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: Month: 2

    Measured by Electroencephalography (EEG) results.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Saint-Etienne Métropole

Registry information

Official study title

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

Acronym: SI-VIM

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2019
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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