Clinical trial NCT03986229: Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
Official title: Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ehlers-Danlos Syndrome
Keywords: ehlers-danlos syndrome
static balance
custom compression garments
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 15 patients exposed to the AB sequence and 15 patients exposed to the BA sequence
Primary purpose: SUPPORTIVE_CARE

Brief summary: Studies have shown the existence of a proprioceptive deficit in patients with Ehlers Danlos Syndrome (EDS) (genetic pathology of connective tissue with hypermobility, multifactor joint instability). A study dating from 2010 showed a qualitative improvement in disability when wearing compression garments (CG) in this pathology, particularly in the fields of proprioception and balance.

The purpose of this study is to quantify the effect of CG on standing static balance in patients with EDS.

Detailed description: To evaluate the effect of CG on standing static balance in patients with EDS, this study is a pilot study, carried out according to a cross-over scheme of type AB/BA.

Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B). Patients will be randomly assigned to 2 groups: the AB or BA sequence will be randomized for each patient.

For each evaluation, a measurement with eyes open and eyes closed will be performed.

A clinical balance assessment by the Berg test will be performed for each of the conditions.

Eligibility criteria: Inclusion Criteria:

* EDS patients over 18 years of age walking around without technical assistance.
* Patients will need to be diagnosed both during the interview (presence of a family history, hypermobility and joint instability that has been evolving for years) and with a guide for analysis from EDS to AP-HP.
* Beighton's score must be 5/9 or higher.
* Free from any other pathology likely to have an impact on the balance.
* Patient with a CG as part of his or her management of the EDS
* Sufficient understanding to understand the objectives of the study and give consent.
* Patient affiliated or benefiting from a social security scheme
* Allergies to one of the components (Polyamide and Elastane) of the CG
* Recent compression garments less than 6 months old.

Exclusion Criteria:

* Patient under guardianship, curators, justice protection.
* Comorbidity likely to influence balance.
* Significant pain (assessed by the patient) induced by the use of CG.
* Any acute event requires the postponement of the assessment to ensure that the patient's progress is in the usual conditions.
* Any acute pathology having an impact on the musculoskeletal system and/or general condition.
* Pregnancy/breastfeeding
* Compression garments over 6 months old.

Primary outcomes:
measure: Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments
timeFrame: 15 minutes
measure: Evaluate the variation in the travel speed of the "center of pressure" without compression garments.
timeFrame: 30 minutes
Secondary outcomes:
measure: Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments
timeFrame: 15 minutes
measure: Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de Medecine physique et réadaptation
state: Salies Du Salat
Study officials:
affiliation: CHU Toulouse
name: Thomas Van Den Bossche
role: PRINCIPAL_INVESTIGATOR
References: