Mirror Therapy Rehabilitation of the Upper Limb After Stroke (NEURO-MIROIR 2)

NCT ID: NCT04119544

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2028-07-31

Brief Summary

Hemiparesis is a common motor disorder after a stroke. The majority of patients do not recover functional use of their paretic upper limb.

The use of mirror therapy allows the activation of the mirror neurons involved to stimulate brain plasticity after brain damage.The IVS (Intensive Visual Stimulation) device allows an easy implementation of mirror therapy by filming the valid upper limb and projecting the inverted image onto a screen placed above the parietal arm thus producing the illusion of movement of the parietal arm.

The main hypothesis of this study is that the structured practice of a large number of upper limb targeted movement repetitions using an intensive visual numerical simulation device as a partial replacement for routine care (conventional occupational therapy) in the sub-acute phase of stroke will increase the active function (motor function and functional abilities) of the distal end of the upper limb compared to conventional rehabilitation.

Objectives: This randomized controlled trial will evaluate the effects of partial substitution of routine care (occupational therapy) by structured movement repetition programs by Intensive Visual Simulation using an IVS3 device, on the distal motor control of the upper hemiparesis limb, between 4 and 10 weeks after the stroke, compared to a program with conventional care alone.

Detailed Description

Hemiparesis is a common motor disorder after a stroke. The majority of patients do not reuse their paretic upper limb.

Hypothesis: The structured practice of repeating upper limb movements by Intensive Visual Simulation will increase distal motor control, and improve the objective functional abilities of the upper limb.

Main Objective:Evaluate in a controlled protocol the effects, on the distal motor control of the upper hemiparesis limb, between 4 and 10 weeks after stroke, of 6 weeks of partial substitution of routine care (occupational therapy) by structured movement repetition programs by Intensive Visual Simulation using an IVS3 device, compared to 6 weeks of a program involving only conventional rehabilitation care, in a population of moderate to severe hemiparesis stroke patients in subacute phase.

Device Description: The IVS3 (Intensive Visual Simulation) rehabilitation device, marketed by Dessintey, allows the implementation of intensive mirror therapy by making it more immersive, ergonomic, and accessible. The IVS3 device consists of a hollow table adjustable in height, a touch screen dedicated to the therapist to set up the device and a large screen adjustable in height and sliding laterally to overlap the upper limb and thus allow the illusion that the limb visible on the screen is the paretic upper limb.

Methods: Multicentric randomised controlled Trial.

Risk/Constraint: To our knowledge, this research does not involve any risks other than those of daily life. The medical device will be used under normal conditions of use as described in the user manual. No contraindications are specified for this device. A risk of discomfort may be felt by the patient during the first few minutes of use. Possibility of feeling tired.

Research duration : 8 years Duration of patient participation : 18 weeks

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional Rehabilitation

at least 4 sessions/week for 6 weeks, from 1 hour of conventional upper limb rehabilitation by an occupational therapist.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: OTHER

upper limb rehabilitation involving submaximal passive amplitude stretching movements, inhibition postures, active efforts assisted of varying difficulty, target approach exercises with or without elbow support and gripping tasks, adapted to the upper limb's paresis abilities. The patient will be encouraged to gradually dispense with the assistance provided by the therapist or any technical assistance (suspension...) and thus to carry out the exercises in free active as soon as possible.

Intensive Visual Simulation

at least 4 sessions/week for 6 weeks, of 1 hour of upper limb rehabilitation including 45 minutes of conventional rehabilitation (occupational therapy) and 15 minutes of work with a medical device allowing intensive visual digital simulation.

Group Type: EXPERIMENTAL

Conventional rehabilitation

Intervention Type: OTHER

upper limb rehabilitation involving submaximal passive amplitude stretching movements, inhibition postures, active efforts assisted of varying difficulty, target approach exercises with or without elbow support and gripping tasks, adapted to the upper limb's paresis abilities. The patient will be encouraged to gradually dispense with the assistance provided by the therapist or any technical assistance (suspension...) and thus to carry out the exercises in free active as soon as possible.

Intensive Visual Simulation

Intervention Type: DEVICE

• First week: observation, mentalization and then attempt to perform the movements on the screen.
• Second and third weeks: production of analytical movements of wrist flexion/extension, pronation/supination, finger flexion/extension, thumb opposition.
• From the 4th week until the end: depending on the patient's motor capacities, continuation of the work of the previous 2 weeks or introduction of more functional work with object manipulation, gripping work.

Conventional rehabilitation upper limb rehabilitation involving submaximal passive amplitude stretching movements, inhibition postures, active efforts assisted of varying difficulty, target approach exercises with or without elbow support and gripping tasks, adapted to the upper limb's paresis abilities. The patient will be encouraged to gradually dispense with the assistance provided by the therapist or any technical assistance (suspension...) and thus to carry out the exercises in free active as soon as possible.

Interventions

Conventional rehabilitation

upper limb rehabilitation involving submaximal passive amplitude stretching movements, inhibition postures, active efforts assisted of varying difficulty, target approach exercises with or without elbow support and gripping tasks, adapted to the upper limb's paresis abilities. The patient will be encouraged to gradually dispense with the assistance provided by the therapist or any technical assistance (suspension...) and thus to carry out the exercises in free active as soon as possible.

Intervention Type: OTHER

Intensive Visual Simulation

• First week: observation, mentalization and then attempt to perform the movements on the screen.
• Second and third weeks: production of analytical movements of wrist flexion/extension, pronation/supination, finger flexion/extension, thumb opposition.
• From the 4th week until the end: depending on the patient's motor capacities, continuation of the work of the previous 2 weeks or introduction of more functional work with object manipulation, gripping work.

Conventional rehabilitation upper limb rehabilitation involving submaximal passive amplitude stretching movements, inhibition postures, active efforts assisted of varying difficulty, target approach exercises with or without elbow support and gripping tasks, adapted to the upper limb's paresis abilities. The patient will be encouraged to gradually dispense with the assistance provided by the therapist or any technical assistance (suspension...) and thus to carry out the exercises in free active as soon as possible.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years;
• Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline;
• Total sub-scores wrist and hand of th Fugl-Meyer < 16
• Patient having agreed to sign an informed consent
• patient being affiliated to the French Social Security

Exclusion Criteria

• Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible
• Phasic disorders that prevent the understanding of instructions
• Patient include in an other clinical trial
• Neurological conditions prior to stroke
• Patient who had mirror therapy or IVS rehabilitation before inclusion
• Rheumatological pathology of the hand and wrist
• Person under legal protection measure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinalliance Villiers-sur-Orge

UNKNOWN

Sponsor Role: collaborator

Centre de Rééducation Fonctionnelle Pasori

UNKNOWN

Sponsor Role: collaborator

CHU de Reims

OTHER

Sponsor Role: collaborator

Clinique Les Grands Chênes

UNKNOWN

Sponsor Role: collaborator

Clinique Napoléon

UNKNOWN

Sponsor Role: collaborator

Clinique Mariénia

UNKNOWN

Sponsor Role: collaborator

Clinique Verdaich

UNKNOWN

Sponsor Role: collaborator

Clinique Les Trois Soleils

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe DURET, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Les Trois Soleils

Manuel Wiese, MD

Role: PRINCIPAL_INVESTIGATOR

Clinalliance Villiers-sur-Orge

Nikolay DOBREV, MD

Role: PRINCIPAL_INVESTIGATOR

CRF PASORI

François BOYER, Professor

Role: PRINCIPAL_INVESTIGATOR

Hôpital Sébastopol, CHU de Reims

Caroline TERRACOL, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Marienia Inicea

Jean-Marc GUEBLE, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Verdaich

Adrien PETIT, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Les Grands Chênes Inicea

Magali CAPLANNE, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Napoléon Inicea

Locations

CHU Sébastopol

Reims, Champagne-Ardenne, France

Site Status: NOT_YET_RECRUITING

Clinique Napoléon

Saint-Paul-lès-Dax, Nouvelle-Aquitaine, France

Site Status: NOT_YET_RECRUITING

Clinique Les Trois Soleils

Boissise-le-Roi, , France

Site Status: RECRUITING

CRF Pasori

Cosne-Cours-sur-Loire, , France

Site Status: RECRUITING

Clinalliance Villiers-sur Orge

Villiers-sur-Orge, , France

Site Status: RECRUITING

Countries

France

Central Contacts

SAS Les POMPON

Role: CONTACT

ag.grosmaire@les-trois-soleils.fr

+33164718000

Christophe DURET, MD

Role: CONTACT

direction@les-trois-soleils.fr

+33 164 718 000

Facility Contacts

François BOYER, PhD

Role: primary

fboyer@chu-reims.fr

+33 326 788 597

Véronique ROUVROY

Role: backup

vrouvroy@chu-reims.fr

+33 326 788 597

Magali CAPLANNE, MD

Role: primary

magali.caplanne@inicea.fr

+33558912200

Christophe Duret, MD

Role: primary

ch.duret@les-trois-soleils.fr

Nikolay Dobrev, MD

Role: primary

n.dobrev@pasori.fr

Manuel Wiese, MD

Role: primary

dr.wiese@villiers.clinalliance.fr

Other Identifiers

2019-A00966-51

Identifier Type: -

Identifier Source: org_study_id