Clinical trial NCT04119544: Mirror Therapy Rehabilitation of the Upper Limb After Stroke (NEURO-MIROIR 2)
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
mirror therapy
rehabilitation
hemiparesis
upper limb
function
motor control
Lead sponsor: Clinique Les Trois Soleils
Sponsor class: OTHER
Collaborators: name: Clinalliance Villiers-sur-Orge
name: Centre de Rééducation Fonctionnelle Pasori
name: CHU de Reims
name: Clinique Les Grands Chênes
name: Clinique Napoléon
name: Clinique Mariénia
name: Clinique Verdaich
First posted: 2019-10-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change of motor performance score on the Fugl-Meyer sub-score wrist/hand
timeFrame: between Day1(day of program start), Week6 (end of the program)
Secondary outcomes:
measure: Change of motor performance score on the Fugl-Meyer
timeFrame: between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)
measure: Change of motor capacity on Stroke Upper Limb Capacity Scale (SULCS)
timeFrame: between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)
measure: Change of spasticity score of the elbow flexors, wrist flexors, finger flexors measured by the Modified Ashworth Scale (MAS)
timeFrame: between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)
measure: Change in perceived stroke impact on the Stroke Impact Scale (SIS)
timeFrame: between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program)
Other outcomes:
Locations:
city: Reims
country: France
facility: CHU Sébastopol
state: Champagne-Ardenne
city: Saint-Paul-lès-Dax
country: France
facility: Clinique Napoléon
state: Nouvelle-Aquitaine
city: Boissise-le-Roi
country: France
facility: Clinique Les Trois Soleils
city: Cosne-Cours-sur-Loire
country: France
facility: CRF Pasori
city: Villiers-sur-Orge
country: France
facility: Clinalliance Villiers-sur Orge
Study officials:
affiliation: Clinique Les Trois Soleils
name: Christophe DURET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinalliance Villiers-sur-Orge
name: Manuel Wiese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CRF PASORI
name: Nikolay DOBREV, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Sébastopol, CHU de Reims
name: François BOYER, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Marienia Inicea
name: Caroline TERRACOL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Verdaich
name: Jean-Marc GUEBLE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Les Grands Chênes Inicea
name: Adrien PETIT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Napoléon Inicea
name: Magali CAPLANNE, MD
role: PRINCIPAL_INVESTIGATOR
References: