VITALISED /Evaluation of an innovative proprioceptive therapy for the treatment of hypermobile Ehlers-Danlos Syndrome
Project overview
This study aims to better characterize Hypermobile Ehlers-Danlos Syndrome (hEDS) and to evaluate the effectiveness of a non-pharmacological therapeutic strategy combining proprioceptive substitution via the use of compression garments (NOVATEX MEDICAL) and sensorimotor reprogramming (SMR) using a motorized platform (HUBER 360® Evolution, LPG MEDICAL), in the treatment of 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 periods (M):
- M0-M4: Standardization of medical care
- M4-M8: Sensorimotor reprogramming (12 sessions) coupled with the daily wearing (6 hours a day) of either compression garments (experimental group) or minimally compressive garments (control group)
- M8-M12: Discontinuation of the therapeutic intervention and assessment of residual effects after 4 months
Patients will be assessed at each stage of the study (i.e. M0, M4, M8, M12) using neuropsychological and perceptual tests, behavioral measurements (e.g. posture, locomotion) in virtual reality environments (including sensory conflict and attention sharing situations – with kinematic, kinetic, and electromyographic analysis), and home questionnaires on symptoms (e.g. fatigue, anxiety, depression, pain, resilience, alexithymia) and quality of life (e.g. functional autonomy, mobility, sleep-wake rhythm).
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).
Clinical Network
Caen University Hospital (Pain Assessment and Treatment Center, Functional Explorations, Physical Medicine and Rehabilitation, Ophthalmology), Rare Diseases Competence Center in Caen, National Reference Center for Ehlers-Danlos Syndromes, Regional Health Training Institute, and the patient association SED’in France.
Doctoral theses
Emma G. DUPUY (2015–2019, advisor: Leslie DECKER) and Valentin LANA (CIFRE COMETE/DevAH/NOVATEX MEDICAL, 2018–2021, advisors: Leslie DECKER & Julien FRÈRE). This project is co-funded by the European Union and the Normandy Region as part of the 2014–2020 ERDF/ESF operational program.
