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

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.

Study Overview

• Status: Completed
• Conditions: Ehlers-Danlos Syndrome
• Intervention / Treatment: Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Salies Du Salat
    • Toulouse, Salies Du Salat, France, 31260
      • Service de Médecine Physique et Réadaptation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With compression garments; Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.	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.
Active Comparator: Without compression garments; Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Thomas Van Den Bossche, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ehlers-danlos syndrome; static balance; custom compression garments
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Disease; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Syndrome; Ehlers-Danlos Syndrome
• Other Study ID Numbers: RC31/18/0360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No