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

NCT04025411 | Completed

• 2 other identifiers: 18CH2002019-A00041-56
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Upper limb rehabilitation; Computerized mirror therapy; Hemiparetic; Mirror therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Day: 0, 18, 32, 60

• Change from baseline Barthel index at 18 days, at 32 days, and at 60 days.

  Day: 0, 18, 32, 60

• Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days.

  Day: 0, 18, 32, 60

• Analysis of brain activity

  Month: 2

Study Arms (2)

Experimental group

EXPERIMENTAL

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; Device: Electroencephalography (EEG)

Control group

ACTIVE COMPARATOR

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); Device: Electroencephalography (EEG)

Interventions

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.

Also known as: Computerized Mirror Therapy (TM) device

Experimental group

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).

Control group

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Saint-Etienne Métropole: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Pascal GIRAUX, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 18, 2019
• Study Start: October 28, 2019
• Primary Completion: July 3, 2023
• Study Completion: July 6, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)