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

NCT03986229 | Completed

• 1 other identifier: RC31/18/0360
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ehlers-Danlos Syndrome

Keywords

ehlers-danlos syndrome; static balance; custom compression garments

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments

  15 minutes

• Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments

  30 minutes

Study Arms (2)

With compression garments

ACTIVE COMPARATOR

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.

Without compression garments

ACTIVE COMPARATOR

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.

Interventions

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

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.

With compression garments; Without compression garments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Service de Medecine physique et réadaptation

Toulouse, Salies Du Salat, 31260, France

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Thomas Van Den Bossche

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 15 patients exposed to the AB sequence and 15 patients exposed to the BA sequence

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: April 10, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)