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

NCT04119544 | Recruiting

• 1 other identifier: 2019-A00966-51
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke

Keywords

stroke; mirror therapy; rehabilitation; hemiparesis; upper limb; function; motor control

Outcome Measures

Primary Outcomes (1)

• Change of motor performance score on the Fugl-Meyer sub-score wrist/hand

  Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the sub-score wrist/hand includes items related to movements of the forearm (proximal arm), wrist, hand (distal arm) and speed/coordination during a finger-nose task. The total sub-score range between 0 and 30.

  between Day1(day of program start), Week6 (end of the program)

Secondary Outcomes (4)

• Change of motor performance score on the Fugl-Meyer

  between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)

• Change of motor capacity on Stroke Upper Limb Capacity Scale (SULCS)

  between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)

• Change of spasticity score of the elbow flexors, wrist flexors, finger flexors measured by the Modified Ashworth Scale (MAS)

  between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)

• Change in perceived stroke impact on the Stroke Impact Scale (SIS)

  between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)

Study Arms (2)

Conventional Rehabilitation

ACTIVE COMPARATOR

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

Other: Conventional rehabilitation

Intensive Visual Simulation

EXPERIMENTAL

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.

Other: Conventional rehabilitation; Device: Intensive Visual Simulation

Interventions

Conventional rehabilitation 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.

Conventional Rehabilitation; Intensive Visual Simulation

Intensive Visual Simulation 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.

Intensive Visual Simulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Rheumatological pathology of the hand and wrist
• Person under legal protection measure.

Sponsors & Collaborators

• CHU de Reims: collaborator
• Clinique Les Grands Chênes: collaborator
• Clinique Napoléon: collaborator
• Clinique Mariénia: collaborator
• Clinique Verdaich: collaborator
• Clinique Les Trois Soleils: lead
• Clinalliance Villiers-sur-Orge: collaborator
• Centre de Rééducation Fonctionnelle Pasori: collaborator

Study Sites (5)

CHU Sébastopol

Reims, Champagne-Ardenne, 51092, France

NOT YET RECRUITING

Clinique Napoléon

Saint-Paul-lès-Dax, Nouvelle-Aquitaine, 40990, France

NOT YET RECRUITING

Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

RECRUITING

CRF Pasori

Cosne-Cours-sur-Loire, 58200, France

RECRUITING

Clinalliance Villiers-sur Orge

Villiers-sur-Orge, 91700, France

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christophe DURET, MD

  Clinique Les Trois Soleils

  PRINCIPAL INVESTIGATOR

• Manuel Wiese, MD

  Clinalliance Villiers-sur-Orge

  PRINCIPAL INVESTIGATOR

• Nikolay DOBREV, MD

  CRF PASORI

  PRINCIPAL INVESTIGATOR

• François BOYER, Professor

  Hôpital Sébastopol, CHU de Reims

  PRINCIPAL INVESTIGATOR

• Caroline TERRACOL, MD

  Clinique Marienia Inicea

  PRINCIPAL INVESTIGATOR

• Jean-Marc GUEBLE, MD

  Clinique Verdaich

  PRINCIPAL INVESTIGATOR

• Adrien PETIT, MD

  Clinique Les Grands Chênes Inicea

  PRINCIPAL INVESTIGATOR

• Magali CAPLANNE, MD

  Clinique Napoléon Inicea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SAS Les POMPON

CONTACT

+33164718000; ag.grosmaire@les-trois-soleils.fr

Christophe DURET, MD

CONTACT

+33 164 718 000; direction@les-trois-soleils.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 8, 2019
• Study Start: December 10, 2019
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (5)