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Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome (EDS)

T

Toulouse University Hospital

Status

Completed

Conditions

Ehlers-Danlos Syndrome

Treatments

Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.

Study type

Interventional

Funder types

Other

Identifiers

NCT03986229
RC31/18/0360

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

With compression garments
Active Comparator group
Description:
Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.
Treatment:
Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.
Without compression garments
Active Comparator group
Description:
Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.
Treatment:
Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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