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

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ClinicalTrials.gov Identifier: NCT03986229
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 15 patients exposed to the AB sequence and 15 patients exposed to the BA sequence
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020


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.




Primary Outcome Measures :
  1. Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments [ Time Frame: 15 minutes ]
    Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).

  2. Evaluate the variation in the travel speed of the "center of pressure" without compression garments. [ Time Frame: 30 minutes ]
    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 :
  1. Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments [ Time Frame: 15 minutes ]
    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.

  2. Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments [ Time Frame: 30 minutes ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986229


Contacts
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Contact: Thomas Van Den Bossche 05 61 90 93 44 ext 33 vandenbossche.t@chu-toulouse.fr

Locations
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France
Service de Medecine physique et réadaptation Recruiting
Toulouse, Salies Du Salat, France, 31260
Contact: Thomas Van Den Bossche    05 61 90 93 44    vandenbossche.t@chu-toulouse.fr   
Principal Investigator: Thomas Van Den Bossche         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Thomas Van Den Bossche CHU Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03986229     History of Changes
Other Study ID Numbers: RC31/18/0360
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
ehlers-danlos syndrome
static balance
custom compression garments

Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases