VITALISED Study Overview

VITALISED / Evaluation of an innovative proprioceptive therapeutic approach in the treatment of hypermobile Ehlers-Danlos syndrome

Project presentation

This study aims to better characterize hypermobile Ehlers-Danlos Syndrome (hEDS) and to evaluate the effectiveness of a non-pharmacological therapeutic strategy. This approach combines proprioceptive support through the use of compressive garments (NOVATEX MEDICAL) and sensorimotor reprogramming (SMR) on a motorized platform (HUBER 360® Evolution, LPG MEDICAL) to treat the sensorimotor impairment associated with hEDS.

The study involves 40 hEDS patients and 40 control subjects. Patients will be monitored over a year, divided into three 4-month (M) periods: :

• M0-M4 – Standardization of medical care.
• M4-M8 – Sensorimotor reprogramming (12 sessions) combined with wearing compressive garments (experimental arm) or low-compression garments (control arm) for 6 hours a day.
• M8-M12 – Discontinuation of the studied therapeutic strategy and evaluation of the lasting effects (at 4 months).

Patients will be evaluated at each stage of the study (i.e., M0, M4, M8, and M12) using neuropsychological and perceptual tests, behavioral measurements (i.e., posture, locomotion) in virtual reality (i.e., sensory conflict and divided attention situations – kinematic, kinetic, and electromyographic analysis), as well as home questionnaires regarding symptoms (e.g., fatigue, anxiety, depression, pain, resilience, alexithymia) and quality of life (e.g., functional autonomy, mobility, sleep-wake rhythms).

Promoter and partners

Caen University Hospital (Promoter), COMETE UMR-S 1075 INSERM-UNICAEN (Principal Investigator : Leslie DECKER, Coordinating Physician : Hervé NORMAND), CIREVE – Centre Interdisciplinaire de Réalité Virtuelle (experimental site), NOVATEX MEDICAL (industrial partner).

Healthcare networks

Caen University Hospital (Pain Evaluation and Treatment Center, Functional Explorations, Physical and Rehabilitation Medicine, Ophthalmology), Caen Rare Diseases Competence Center, National EDS Reference Center, Regional Health Training Institute (IFRS), SED’in France association.

Doctoral theses

Emma G. DUPUY (2015-2019, Supervised by: Leslie DECKER) and Valentin LANA (CIFRE COMETE/DevAH/NOVATEX MEDICAL, 2018-2021, Supervised by: Leslie DECKER & Julien FRÈRE).

This project is co-financed by the European Union and the Normandy Region under the ERDF/ESF 2014-2020 operational program.