Hypermobility Type Ehlers-Danlos SyndromeVECONCT03359135
Compression Garments on Hypermobility Type of Ehlers-Danlos Syndrome (CGhEDS)
An observational study of Hypermobility Type Ehlers-Danlos Syndrome, run by Hôpital Raymond Poincaré at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hypermobility Type Ehlers-Danlos Syndrome
- What is being tested?
- Rehabilitation and Compression Garment
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: hypermobility type of Ehlers-Danlos syndrome
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Gader Nadra
Garches, 92380
Nadra Gader, 0033788127902, nadra.gd@gmail.com
Karelle Benistan, 0033147104440, karelle.benistan@aphp.fr
About this study
Official title: 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.
- Being tested
- Rehabilitation, Compression Garment
- Keywords
- Compression garment
- Medical subject headings
- Ehlers-Danlos syndrome type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Rehabilitation during 4 weeks
Compression GarmentDevice
Rehabilitation associated to wearing CG during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| group1 | hEDS treated with rehabilitation only Receives: Other: Rehabilitation | |
| group 2 | hEDS treated with rehabilitation associated to compression garments wearing Receives: Other: Rehabilitation; Device: Compression Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Centre of pression speed
a stability parameter on a force plate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Apr 2018 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypermobility Type Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Raymond Poincaré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359135
- Sponsor's protocol ID
- hEDS-40
- Acronym
- VECO
- Status last verified
- Feb 2018
- First submitted
- 27 Nov 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37194618
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Garments Effects on Postural Balance of Patients With Hypermobility Type of Ehlers-danlos Syndrome, a Prospective Study on 40 Patients
- ClinicalTrials.gov ID
- NCT03359135
- Acronym / sponsor ID
- VECO / hEDS-40
- Keywords
- Compression garment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hôpital Raymond PoincaréUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 | – | Other: RehabilitationhEDS treated with rehabilitation only |
| group 2 | – | Other: Rehabilitation, Device: Compression GarmenthEDS treated with rehabilitation associated to compression garments wearing |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hypermobility type of Ehlers-Danlos syndrome
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationRehabilitation during 4 weeks | Other | group 2, group1 |
| Compression GarmentRehabilitation associated to wearing CG during 4 weeks | Device | group 2 |
Primary outcome
Centre of pression speed
Time frame: 4 weeks
a stability parameter on a force plate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Derived from this study: PubMed 37194618Benistan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobility Type Ehlers-Danlos Syndrome, run by Hôpital Raymond Poincaré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BENISTAN Karelle, Dr (0033147104440, karelle.benistan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Centre of pression speed (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.