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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Intensive Visual Simulation 3 (IVS3) device; Device: Electroencephalography (EEG); Device: traditional Mirror Therapy (TM)

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal GIRAUX, MD PhD; Phone Number: +33 (0)4.77.12.77.56; Email: pascal.giraux@univ-st-etienne.fr
• Study Contact Backup: Name: Florence RANCON, CRA; Phone Number: +33 (0)4.77.82.94.58; Email: florence.rancon@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • CHU SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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: 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.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Saint-Etienne Métropole
• Investigators: Principal Investigator: Pascal GIRAUX, MD PhD, CHU SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Mirror therapy; Upper limb rehabilitation; Computerized mirror therapy; Hemiparetic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 18CH200; 2019-A00041-56 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No