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NCT04020107: VITALISED
Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
NA trial testing Compressive garment and Somatosensori Remediation in Ehlers-Danlos Syndrome Hypermobility Type (hEDS) in 40 participants. Completed in 25 November 2022.
25 November 2022
Quick facts
| Lead sponsor | University Hospital, Caen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 29 May 2018 |
| Primary completion | 25 November 2022 |
| Estimated completion | 25 November 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Compressive garment and Somatosensori Remediation
Conditions studied
- Ehlers-Danlos Syndrome Hypermobility Type (hEDS) — all drugs for Ehlers-Danlos Syndrome Hypermobility Type (hEDS) →
Sponsor
University Hospital, Caen
Who can join
Adults 18 to 40, any sex, with Ehlers-Danlos Syndrome Hypermobility Type (hEDS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In the absence of a medical consensus, the current management of Ehlers-Danlos Syndrome hypermobility type (hEDS) remains very speculative That's why investigators want in this study to demonstrate the beneficial contribution of an innovative therapeutic strategy combining reprogramming and substitution somatosensory. This therapy is based primarily on the somesthetic substitution provided by compression garments(VC). Indeed, the VC port associated with stimulation of the somesthetic system via a specific program of physiotherapy (e.e. centered on body awareness through movement) could potentiate the effectiveness of care, and therefore enhance its long-term beneficial effect. The patient could thus regain his mobility, his functional independence, and thus considerably increase its quality of life. Thereafter, the practice of an adapted physical activity (APA), by the sensory stimulation induced and its playful nature, will allow patients to preserve and sustain the benefits of taking load previously carried out. Validation of this therapeutic approach would offer an effective solution may subsequently be proposed to the entire medical profession as reference support in the treatment of the hEDS. This study plans to include, over a period of two years, 40 patients with hypermobile Ehlers-Danlos syndrome and 40 healthy volunteers controls. Patients will be followed for a period of one year divided into 3 periods of 4 months, between which they will be evaluated in order to quantify the impact of the intervention performed at each stage of the protocol. Each patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive garments or with low compressive garment during the next 4 months in association with proprioceptive physical therapy. Finally, the 4 last months, patient will participate in an APA with both dance sessions strengthening the body diagram and stretching sessions. The aim of this work is therefore to evaluate the effect of a treatment specifically oriented towards somatosensory remediation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04020107
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04020107 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Caen
- Last refreshed: 2 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04020107.
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