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

Clinique Les Trois Soleils

Status: Enrolling

Conditions: Stroke

Treatments: Other: Conventional rehabilitation; Device: Intensive Visual Simulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04119544

2019-A00966-51

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Conventional Rehabilitation

Active Comparator group

Description:

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

Treatment:

Other: Conventional rehabilitation

Intensive Visual Simulation

Experimental group

Description:

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.

Treatment:

Device: Intensive Visual Simulation

Other: Conventional rehabilitation