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

Ehlers-Danlos Syndrome Clinical Trial

— EDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986229
• Other study ID #: RC31/18/0360
• Status: Completed
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Syndrome

Intervention

Other:
• Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.
Each evaluation will be done according to the following protocol: Evaluation of the pain Berg test One test per condition starting with open eyes Standardized instructions: Break about 15 minutes (wash-out) between each test. Both conditions will be tested on the same day. Evaluation in an environment free from visual and audible interference.

Locations

Country	Name	City	State
France	Service de Medecine physique et réadaptation	Toulouse	Salies Du Salat

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments	Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).	15 minutes
Primary	Evaluate the variation in the travel speed of the "center of pressure" without compression garments.	Evaluate the variation in the travel speed of the "center of pressure" without compression garments. Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).	30 minutes
Secondary	Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments	Evaluate the amplitude of the antero-posterior and lateral oscillations of the COP with and without compression garments Compare the stabilometric data with a clinical trial evaluating the reference balance.	15 minutes
Secondary	Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments	Evaluate the amplitude of the antero-posterior and lateral oscillations of the COP with and without compression garments.; Compare the stabilometric data with a clinical trial evaluating the reference balance.	30 minutes