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Trial record 3 of 12 for:    Recruiting, Not yet recruiting, Available Studies | Ehlers-Danlos syndrome

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

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ClinicalTrials.gov Identifier: NCT03359135
Recruitment Status : Not yet recruiting
First Posted : December 2, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hôpital Raymond Poincaré

Brief Summary:
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.

Condition or disease Intervention/treatment
Hypermobility Type Ehlers-Danlos Syndrome Other: Rehabilitation Device: Compression Garment

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Compression Garments Effects on Postural Balance of Patients With Hypermobility Type of Ehlers-danlos Syndrome, a Prospective Study on 40 Patients
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019


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




Primary Outcome Measures :
  1. Centre of pression speed [ Time Frame: 4 weeks ]
    a stability parameter on a force plate



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hypermobility type of Ehlers-Danlos syndrome
Criteria

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.

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): NCT03359135


Contacts
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Contact: BENISTAN Karelle, Dr 0033147104440 karelle.benistan@aphp.fr
Contact: GADER Nadra, Dr 0033788127902 nadra.gd@gmail.com

Locations
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France
Gader Nadra Not yet recruiting
Garches, France, 92380
Contact: Nadra Gader    0033788127902    nadra.gd@gmail.com   
Contact: Karelle Benistan    0033147104440    karelle.benistan@aphp.fr   
Sponsors and Collaborators
Hôpital Raymond Poincaré

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Responsible Party: Hôpital Raymond Poincaré
ClinicalTrials.gov Identifier: NCT03359135     History of Changes
Other Study ID Numbers: hEDS-40
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
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 Hôpital Raymond Poincaré:
Compression garment
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