Informations générales (source: ClinicalTrials.gov)

NCT04119544 En recrutement IDF
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. (NEUROMIROIR2)
Interventional
  • Accident vasculaire cérébral
N/A
Clinique Les Trois Soleils (Voir sur ClinicalTrials)
décembre 2019
juillet 2028
05 avril 2025
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CLINIQUE LES TROIS SOLEILS Christophe Duret, MD En recrutement IDF Contact (sur clinicalTrials)
CLINIQUE MEDICALE DE VILLIERS SUR ORGE Manuel Wiese, MD En recrutement IDF Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CRF Pasori - 58200 - Cosne-Cours-sur-Loire - France Nikolay Dobrev, MD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Sébastopol - 51092 - Reims - Champagne-Ardenne - France François BOYER, PhD Recrutement non commencé Contact (sur clinicalTrials)
Clinique Napoléon - 40990 - Saint-Paul-lès-Dax - Nouvelle-Aquitaine - France Magali CAPLANNE, MD Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
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



- 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.