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Mirror Therapy Rehabilitation of the Upper Limb After Stroke (NEURO-MIROIR 2) (NEUROMIROIR2)

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ClinicalTrials.gov Identifier: NCT04119544
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
Clinalliance Villiers-sur-Orge
Centre de Rééducation Fonctionnelle Pasori
Information provided by (Responsible Party):
Clinique Les Trois Soleils

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.


Condition or disease Intervention/treatment Phase
Stroke Other: Conventional rehabilitation Device: Intensive Visual Simulation Not Applicable

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 : 3 years Duration of patient participation : 18 weeks


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : November 4, 2019
Estimated Primary Completion Date : November 4, 2021
Estimated Study Completion Date : November 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Conventional Rehabilitation
at least 4 sessions/week for 6 weeks, from 1 hour of conventional upper limb rehabilitation by an occupational therapist.
Other: 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.

Experimental: 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.
Other: 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
  • 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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]

    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

    1. 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)
    2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    3. Considerable increase in muscle tone, passive movement difficult
    4. Affected part(s) rigid in flexion or extension

  4. 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) ]
    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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119544


Contacts
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Contact: Cécile FAURE direction@les-trois-soleils.fr
Contact: Christophe DURET, MD +33 1 64 71 80 00 direction@les-trois-soleils.fr

Locations
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France
Clinique Les Trois Soleils Not yet recruiting
Boissise-le-Roi, France, 77310
Contact: Christophe Duret, MD       ch.duret@les-trois-soleils.fr   
Principal Investigator: Christophe Duret, MD         
CRF Pasori Not yet recruiting
Cosne-Cours-sur-Loire, France, 58200
Contact: Nikolay Dobrev, MD       n.dobrev@pasori.fr   
Principal Investigator: Nikolay Dobrev, MD         
Clinalliance Villiers-sur Orge Not yet recruiting
Villiers-sur-Orge, France, 91700
Contact: Yannick Blancheteau, MD       dr.blancheteau@villiers.clinalliance.fr   
Sub-Investigator: Elisabeth Alais, MD         
Principal Investigator: Yannick Blancheteau, MD         
Sub-Investigator: Manuel Wiese, MD         
Sponsors and Collaborators
Clinique Les Trois Soleils
Clinalliance Villiers-sur-Orge
Centre de Rééducation Fonctionnelle Pasori
Investigators
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Principal Investigator: Christophe DURET, MD Clinique Les Trois Soleils
Principal Investigator: Yannick BLANCHETEAU, MD Clinalliance Villiers-sur-Orge
Principal Investigator: Nikolay DOBREV, MD CRF PASORI

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Responsible Party: Clinique Les Trois Soleils
ClinicalTrials.gov Identifier: NCT04119544     History of Changes
Other Study ID Numbers: 2019-A00966-51
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinique Les Trois Soleils:
stroke
mirror therapy
rehabilitation
hemiparesis
upper limb
function
motor control
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases