NCT03359135

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

November 27, 2017

Last Update Submit

February 27, 2018

Conditions

Keywords

Compression garment

Outcome Measures

Primary Outcomes (1)

  • Centre of pression speed

    a stability parameter on a force plate

    4 weeks

Study Arms (2)

group1

hEDS treated with rehabilitation only

Other: Rehabilitation

group 2

hEDS treated with rehabilitation associated to compression garments wearing

Other: RehabilitationDevice: Compression Garment

Interventions

Rehabilitation during 4 weeks

group 2group1

Rehabilitation associated to wearing CG during 4 weeks

group 2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hypermobility type of Ehlers-Danlos syndrome

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gader Nadra

Garches, 92380, France

Location

Related Publications (1)

  • Benistan K, Foy M, Gillas F, Genet F, Kane M, Barbot F, Vaugier I, Bonnyaud C, Gader N. Effects of compression garments on balance in hypermobile Ehlers-Danlos syndrome: a randomized controlled trial. Disabil Rehabil. 2024 May;46(9):1841-1850. doi: 10.1080/09638288.2023.2209742. Epub 2023 May 17.

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

BENISTAN Karelle, Dr

CONTACT

GADER Nadra, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

April 1, 2018

Primary Completion

October 1, 2018

Study Completion

April 1, 2019

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations