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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

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Evaluate the variation in the travel speed of the "center of pressure" with VCSM [ Time Frame: 15 minutes ]
    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 VCSM. [ Time Frame: 30 minutes ]
    Evaluate the variation in the travel speed of the "center of pressure" without VCSM. Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Evaluate the amplitude of the antero-posterior and lateral oscillations without VCSM [ Time Frame: 15 minutes ]
    Evaluate the amplitude of the antero-posterior and lateral oscillations of the COP with and without VCSM. Compare the stabilometric data with a clinical trial evaluating the reference balance.
  • Evaluate the amplitude of the antero-posterior and lateral oscillations without VCSM [ Time Frame: 30 minutes ]
    Evaluate the amplitude of the antero-posterior and lateral oscillations of the COP with and without VCSM. Compare the stabilometric data with a clinical trial evaluating the reference balance.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
Official Title  ICMJE Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Ehlers-Danlos Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.
  • 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.
    Intervention: Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Van Den Bossche 05 61 90 93 44 ext 33 vandenbossche.t@chu-toulouse.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986229
Other Study ID Numbers  ICMJE RC31/18/0360
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Van Den Bossche CHU Toulouse
PRS Account University Hospital, Toulouse
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP