Compression Garments on Hypermobility Type of Ehlers-Danlos Syndrome (CGhEDS) (VECO)

February 27, 2018 updated by: Hôpital Raymond Poincaré

Compression Garments Effects on Postural Balance of Patients With Hypermobility Type of Ehlers-danlos Syndrome, a Prospective Study on 40 Patients

This study evaluates the effects of wearing a compression garment on the postural balance of patients with hypermobility type of Ehlers-Danlos syndrome, in randomised controlled study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Gader Nadra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hypermobility type of Ehlers-Danlos syndrome

Description

Inclusion Criteria:

  • Age ≥16 years
  • hEDS with the 2017 diagnostic criteria .
  • A normal neurological examination with no sensory disorders, no cerebellar syndrome or vestibular syndrome.
  • An optimal balanced analgesic treatment before inclusion
  • Patients who have not modified their physical treatment (physiotherapy) since 6 months.

Exclusion Criteria:

  • Surgery of the lower limb (hip, knee or ankle)
  • Patient having already wear compression garments in the year preceding.
  • Neurological history of sensory , vestibular or cerebellar disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group1
hEDS treated with rehabilitation only
Other: Rehabilitation
Rehabilitation during 4 weeks
group 2
hEDS treated with rehabilitation associated to compression garments wearing
Other: Rehabilitation
Rehabilitation during 4 weeks
Device: Compression Garment
Rehabilitation associated to wearing CG during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Centre of pression speed
Time Frame: 4 weeks
a stability parameter on a force plate
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Raymond Poincaré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hEDS-40

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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