StrokeNEUROMIROIR2NCT04119544
Mirror Therapy Rehabilitation of the Upper Limb After Stroke (NEURO-MIROIR 2)
A study testing Conventional rehabilitation and Intensive Visual Simulation in people with Stroke, run by Clinique Les Trois Soleils at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional rehabilitation and Intensive Visual Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Dec 2019to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Clinique Les Trois Soleils
Boissise-le-Roi, 77310
Christophe Duret, MD, ch.duret@les-trois-soleils.fr
Christophe Duret, MD
- Recruiting
CRF Pasori
Cosne-Cours-sur-Loire, 58200
Nikolay Dobrev, MD, n.dobrev@pasori.fr
Nikolay Dobrev, MD
- Not yet recruiting
CHU Sébastopol
Reims, Champagne-Ardenne, 51092
François BOYER, PhD, +33 326 788 597, fboyer@chu-reims.fr
Véronique ROUVROY, +33 326 788 597, vrouvroy@chu-reims.fr
- Not yet recruiting
Clinique Napoléon
Saint-Paul-lès-Dax, New Aquitaine, 40990
Magali CAPLANNE, MD, +33558912200, magali.caplanne@inicea.fr
Carole BALVA, MD
- Recruiting
Clinalliance Villiers-sur Orge
Villiers-sur-Orge, 91700
Manuel Wiese, MD, dr.wiese@villiers.clinalliance.fr
Elisabeth Alais, MD
About this study
Official title: Intensive Rehabilitation Program With Intensive Visual Numerical Simulation Device for Improving Distal Motor Performance and Upper Limb Functional Capacity in Subacute Hemiparetics After Stroke. Randomized Controlled Trial.
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.
Read more
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.
Read the 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
- Being tested
- Conventional rehabilitation, Intensive Visual Simulation
- Keywords
- stroke, mirror therapy, rehabilitation, hemiparesis, upper limb, function, motor control
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilitationOther
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 SimulationDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation | Active comparator | at least 4 sessions/week for 6 weeks, from 1 hour of conventional upper limb rehabilitation by an occupational therapist. Receives: 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. Receives: Other: Conventional rehabilitation; Device: Intensive Visual Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between Day1(day of program start), Week6 (end of the program)
Secondary outcomes (4)
Change of motor performance score on the Fugl-Meyer
Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the test includes items related to movements of the shoulder, elbow, forearm (proximal arm), and wrist and hand (distal arm). The total scores range between 0 and 66.
Measured: 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)
The scale measures active upper limb capacity in hemiparesis based on 10 items, with each item having a possible score of 0 or 1. Three items for arm capacity without active hand capacity, four items for arm capacity and basic hand capacity and three items for complex hand capacity.The total scores range between 0 and 10.
Measured: 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)
The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring :0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range Of Movement (ROM)
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: 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)
The Stroke Impact Scale (SIS) is a 59 item patient reported outcome measure, covering 8 domains: strength (4 items), hand function (5 items), mobility (9 items), activities of daily living (10 items), memory (7 items), communication (7 items), emotion (9 items), and handicap (8 items). Domains are scored on a metric of 0 to 100, with higher scores indicating better self-reported health. Four of the scales of the SIS can be combined into a composite physical domain (strength, hand function, physical and instrumental activities of daily living, and mobility), with scores also presented on a 0 to 100 metric.
Measured: between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Dec 2019
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Les Trois Soleils
- Sponsor type
- University, hospital or other
- Collaborators
- Clinalliance Villiers-sur-Orge, Centre de Rééducation Fonctionnelle Pasori, CHU de Reims, Clinique Les Grands Chênes, Clinique Napoléon, Clinique Mariénia, Clinique Verdaich
- Responsible party
- Sponsor
- Investigators
- Christophe DURET, MD, Principal investigator, Clinique Les Trois SoleilsManuel Wiese, MD, Principal investigator, Clinalliance Villiers-sur-OrgeNikolay DOBREV, MD, Principal investigator, CRF PASORIFrançois BOYER, Professor, Principal investigator, Hôpital Sébastopol, CHU de ReimsCaroline TERRACOL, MD, Principal investigator, Clinique Marienia IniceaJean-Marc GUEBLE, MD, Principal investigator, Clinique VerdaichAdrien PETIT, MD, Principal investigator, Clinique Les Grands Chênes IniceaMagali CAPLANNE, MD, Principal investigator, Clinique Napoléon Inicea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119544
- Sponsor's protocol ID
- 2019-A00966-51
- Acronym
- NEUROMIROIR2
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Rehabilitation Program With Intensive Visual Numerical Simulation Device for Improving Distal Motor Performance and Upper Limb Functional Capacity in Subacute Hemiparetics After Stroke. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04119544
- Acronym / sponsor ID
- NEUROMIROIR2 / 2019-A00966-51
- Conditions
- Stroke
- Keywords
- stroke, mirror therapy, rehabilitation, hemiparesis, upper limb, function, motor control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Clinique Les Trois SoleilsUniversity, hospital or other
- Collaborators
- Clinalliance Villiers-sur-Orge, Centre de Rééducation Fonctionnelle Pasori, CHU de Reims, Clinique Les Grands Chênes, Clinique Napoléon, Clinique Mariénia, Clinique Verdaich
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Other: Conventional rehabilitationat least 4 sessions/week for 6 weeks, from 1 hour of conventional upper limb rehabilitation by an occupational therapist. |
| Intensive Visual Simulation | Experimental | Other: Conventional rehabilitation, Device: Intensive Visual Simulationat 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional rehabilitationupper 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. | Other | Conventional Rehabilitation, Intensive Visual Simulation |
| 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. | Device | Intensive Visual Simulation |
Primary outcome
Change of motor performance score on the Fugl-Meyer sub-score wrist/hand
Time frame: between Day1(day of program start), Week6 (end of the program)
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.
4 secondary outcomes
Change of motor performance score on the Fugl-Meyer
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe DURET, MD principal investigator
Clinique Les Trois Soleils
Manuel Wiese, MD principal investigator
Clinalliance Villiers-sur-Orge
Nikolay DOBREV, MD principal investigator
CRF PASORI
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional rehabilitation and Intensive Visual Simulation in people with Stroke, run by Clinique Les Trois Soleils at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SAS Les POMPON (+33164718000, ag.grosmaire@les-trois-soleils.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of motor performance score on the Fugl-Meyer sub-score wrist/hand (time frame: between Day1(day of program start), Week6 (end of the program)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.