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

Primary Purpose

Ehlers-Danlos Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Ehlers-Danlos Syndrome focused on measuring ehlers-danlos syndrome, static balance, custom compression garments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Service de Medecine physique et réadaptation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

With compression garments

Without compression garments

Arm Description

Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03986229

First Posted

June 11, 2019

Last Updated

December 14, 2022

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT03986229

Brief Title

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

Acronym

EDS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

April 10, 2019 (Actual)

Primary Completion Date

March 15, 2022 (Actual)

Study Completion Date

March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ehlers-Danlos Syndrome

Keywords

ehlers-danlos syndrome, static balance, custom compression garments

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

15 patients exposed to the AB sequence and 15 patients exposed to the BA sequence

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

With compression garments

Arm Type

Active Comparator

Arm Description

Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.

Arm Title

Without compression garments

Arm Type

Active Comparator

Arm Description

Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments

Description

Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).

Time Frame

15 minutes

Title

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

Description

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

15 minutes

Title

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

Description

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Van Den Bossche

Organizational Affiliation

CHU Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Medecine physique et réadaptation

City

Toulouse

State/Province

Salies Du Salat

ZIP/Postal Code

31260

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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