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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intensive Visual Simulation 3 (IVS3) device
traditional Mirror Therapy (TM)
Electroencephalography (EEG)
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, Upper limb rehabilitation, Computerized mirror therapy, Hemiparetic, Mirror therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chu Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm 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).

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
Analysis of brain activity
Measured by Electroencephalography (EEG) results.

Full Information

First Posted
July 17, 2019
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Saint-Etienne Métropole
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1. Study Identification

Unique Protocol Identification Number
NCT04025411
Brief Title
Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.
Acronym
SI-VIM
Official Title
Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Saint-Etienne Métropole

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Upper limb rehabilitation, Computerized mirror therapy, Hemiparetic, Mirror therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm 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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG).
Intervention Type
Device
Intervention Name(s)
Intensive Visual Simulation 3 (IVS3) device
Other Intervention Name(s)
Computerized Mirror Therapy (TM) device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
traditional Mirror Therapy (TM)
Intervention Description
Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
Intervention Type
Device
Intervention Name(s)
Electroencephalography (EEG)
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
Description
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).
Time Frame
Day: 0, 18, 32, 60
Secondary Outcome Measure Information:
Title
Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days.
Description
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).
Time Frame
Day: 0, 18, 32, 60
Title
Change from baseline Barthel index at 18 days, at 32 days, and at 60 days.
Description
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).
Time Frame
Day: 0, 18, 32, 60
Title
Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days.
Description
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).
Time Frame
Day: 0, 18, 32, 60
Title
Analysis of brain activity
Description
Measured by Electroencephalography (EEG) results.
Time Frame
Month: 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal GIRAUX, MD PhD
Phone
(0)4.77.12.77.56
Ext
+33
Email
pascal.giraux@univ-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence RANCON, CRA
Phone
(0)4.77.82.94.58
Ext
+33
Email
florence.rancon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MD PhD
First Name & Middle Initial & Last Name & Degree
Agnès CONDEMINE, MD
First Name & Middle Initial & Last Name & Degree
Bérénice ZAGORDA, MD
First Name & Middle Initial & Last Name & Degree
Bruno FERNADEZ, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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