Ehlers-Danlos Syndrome Hypermobility Type (hEDS)VITALISEDNCT04020107
Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
A study testing Compressive garment and Somatosensori Remediation in people with Ehlers-Danlos Syndrome Hypermobility Type (hEDS), run by University Hospital, Caen at 1 site in France.
Trial summary
In the absence of a medical consensus, the current management of Ehlers-Danlos Syndrome hypermobility type (hEDS) remains very speculative That's why investigators want in this study to demonstrate the beneficial contribution of an innovative therapeutic strategy combining reprogramming and substitution somatosensory. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
- What is being tested?
- Compressive garment and Somatosensori Remediation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2018to 25 Nov 2022
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For EDS patients :
- Subjects aged 18 to 40,
- SEDh patients newly diagnosed for less than 2 years according to international criteria of 2017,
- Having a Body Mass Index (BMI) of less than 30,
- Affiliated to a social security scheme,
- Having read the information document and given in writing their free and informed consent to participate in the study.
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- For healthy volunteers :
- Subjects aged 18 to 40,
- Having a Body Mass Index (BMI) of less than 30,
- Having a Beigthon score <5 (no joint hypermobility),
- Having normal muscle strength,
- Affiliated to a social security scheme,
- Having read the information document and given in writing their free and informed consent to participate in the study.
Who cannot join
- For EDS patients :
- Subjects under 18,
- Proprioceptive physiotherapy (Huber 360 platform type, LPG) in progress or already performed,
- previous treatment of hEDS capable of limiting the effects of rehabilitation (e.g. orthodontics, orthoptics),
- Diagnosis of other connective tissue abnormalities,
- Earlier prescription of compression garments,
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- Pregnant or lactating women,
- Lack of effective contraception during the study period for women
- Person under tutorship or curatorship, or deprived of liberty by judicial or administrative decision,
- Mental or physical impossibility to agree to participate in the study,
- Known allergy to one of the components of compression garments,
- Disabling motor impairment, or limiting the performance of motor and psychomotor tests.
- Simultaneous participation in another clinical study.
- For healthy volunteers :
- Subjects under 18,
- History of vascular, neurological, musculoskeletal or vestibular disorders,
- Having orthoptic, orthopedic or orthodontic disorders,
- Previous history or progressive disease of vascular, ophthalmological, neurological, musculoskeletal condition, or vestibular condition
- Pregnant or lactating women,
- Person under tutorship or curatorship, or deprived of liberty by judicial or administrative decision,
- Mental or physical impossibility to agree to participate in the study,
- Simultaneous participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
In the absence of a medical consensus, the current management of Ehlers-Danlos Syndrome hypermobility type (hEDS) remains very speculative That's why investigators want in this study to demonstrate the beneficial contribution of an innovative therapeutic strategy combining reprogramming and substitution somatosensory. This therapy is based primarily on the somesthetic substitution provided by compression garments(VC). Indeed, the VC port associated with stimulation of the somesthetic system via a specific program of physiotherapy (e.e. centered on body awareness through movement) could potentiate the effectiveness of care, and therefore enhance its long-term beneficial effect. The patient could thus regain his mobility, his functional independence, and thus considerably increase its quality of life. Thereafter, the practice of an adapted physical activity (APA), by the sensory stimulation induced and its playful nature, will allow patients to preserve and sustain the benefits of taking load previously carried out. Validation of this therapeutic approach would offer an effective solution may subsequently be proposed to the entire medical profession as reference support in the treatment of the hEDS.
This study plans to include, over a period of two years, 40 patients with hypermobile Ehlers-Danlos syndrome and 40 healthy volunteers controls. Patients will be followed for a period of one year divided into 3 periods of 4 months, between which they will be evaluated in order to quantify the impact of the intervention performed at each stage of the protocol.
Read more
Each patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive garments or with low compressive garment during the next 4 months in association with proprioceptive physical therapy. Finally, the 4 last months, patient will participate in an APA with both dance sessions strengthening the body diagram and stretching sessions.
The aim of this work is therefore to evaluate the effect of a treatment specifically oriented towards somatosensory remediation.
- Being tested
- Compressive garment and Somatosensori Remediation
- 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.
Compressive garment and Somatosensori RemediationOther
Each patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive or low compressive garments associated with specific proprioceptive physiotherapy program during the next 4 months. Finally, the 4 last months, patient will made adapted physical activity with both dance sessions strengthening the body diagram and stretching sessions
| Study group | Role | What they receive |
|---|---|---|
| Compressive garment associated with physical therapy | Active comparator | Not described Receives: Other: Compressive garment and Somatosensori Remediation |
| Low compressive garment associated with physical therapy | Placebo comparator | Not described Receives: Other: Compressive garment and Somatosensori Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysis of center of pressure displacements on force platform
The main evaluation criterion is the complexity of postural control after 8 months of treatment (M8) through an analysis of the organization postural fluctuations (i.e. analysis of center of pressure displacements on force platforms6).
Measured: at month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start29 May 2018
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
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 Ehlers-Danlos Syndrome Hypermobility Type (hEDS)Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020107
- Sponsor's protocol ID
- 17-2012
- Acronym
- VITALISED
- Status last verified
- Feb 2023
- First submitted
- 10 Jul 2019
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valentin Lana. Marqueurs neurophysiologiques et comportementaux du contrôle locomoteur dans le syndrome d'Ehlers-Danlos de type hypermobile. Education. Normandie Université, 2023. Français. ⟨NNT : 2023NORMC293⟩. ⟨tel-04521809⟩
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Somatosensori Remediation for Postural Control in the Treatment of Ehlers-Danlos Syndrome Hypermobility Type (hEDS)
- ClinicalTrials.gov ID
- NCT04020107
- Acronym / sponsor ID
- VITALISED / 17-2012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 15 Jul 2019 (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.
In the absence of a medical consensus, the current management of Ehlers-Danlos Syndrome hypermobility type (hEDS) remains very speculative That's why investigators want in this study to demonstrate the beneficial contribution of an innovative therapeutic strategy combining reprogramming and substitution somatosensory. This therapy is based primarily on the somesthetic substitution provided by compression garments(VC). Indeed, the VC port associated with stimulation of the somesthetic system via a specific program of physiotherapy (e.e. centered on body awareness through movement) could potentiate the effectiveness of care, and therefore enhance its long-term beneficial effect. The patient could thus regain his mobility, his functional independence, and thus considerably increase its quality of life. Thereafter, the practice of an adapted physical activity (APA), by the sensory stimulation induced and its playful nature, will allow patients to preserve and sustain the benefits of taking load previously carried out. Validation of this therapeutic approach would offer an effective solution may subsequently be proposed to the entire medical profession as reference support in the treatment of the hEDS.
This study plans to include, over a period of two years, 40 patients with hypermobile Ehlers-Danlos syndrome and 40 healthy volunteers controls. Patients will be followed for a period of one year divided into 3 periods of 4 months, between which they will be evaluated in order to quantify the impact of the intervention performed at each stage of the protocol.
Each patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive garments or with low compressive garment during the next 4 months in association with proprioceptive physical therapy. Finally, the 4 last months, patient will participate in an APA with both dance sessions strengthening the body diagram and stretching sessions.
The aim of this work is therefore to evaluate the effect of a treatment specifically oriented towards somatosensory remediation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compressive garment associated with physical therapy | Active comparator | Other: Compressive garment and Somatosensori Remediation |
| Low compressive garment associated with physical therapy | Placebo comparator | Other: Compressive garment and Somatosensori Remediation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects aged 18 to 40,
- SEDh patients newly diagnosed for less than 2 years according to international criteria of 2017,
- Having a Body Mass Index (BMI) of less than 30,
- Affiliated to a social security scheme,
- Having read the information document and given in writing their free and informed consent to participate in the study.
Key exclusion criteria (22 listed)
- Subjects under 18,
- Proprioceptive physiotherapy (Huber 360 platform type, LPG) in progress or already performed,
- previous treatment of hEDS capable of limiting the effects of rehabilitation (e.g. orthodontics, orthoptics),
- Diagnosis of other connective tissue abnormalities,
- Earlier prescription of compression garments,
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 |
|---|---|---|
| Compressive garment and Somatosensori RemediationEach patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive or low compressive garments associated with specific proprioceptive physiotherapy program during the next 4 months. Finally, the 4 last months, patient will made adapted physical activity with both dance sessions strengthening the body diagram and stretching sessions | Other | Compressive garment associated with physical therapy, Low compressive garment associated with physical therapy |
Primary outcome
analysis of center of pressure displacements on force platform
Time frame: at month 8
The main evaluation criterion is the complexity of postural control after 8 months of treatment (M8) through an analysis of the organization postural fluctuations (i.e. analysis of center of pressure displacements on force platforms6).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publicationValentin Lana. Marqueurs neurophysiologiques et comportementaux du contrôle locomoteur dans le syndrome d'Ehlers-Danlos de type hypermobile. Education. Normandie Université, 2023. Français. ⟨NNT : 2023NORMC293⟩. ⟨tel-04521809⟩
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compressive garment and Somatosensori Remediation in people with Ehlers-Danlos Syndrome Hypermobility Type (hEDS), run by University Hospital, Caen 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 13 inclusion and 22 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: finished, as of the sponsor's last update on 2 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of center of pressure displacements on force platform (time frame: at month 8). 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 NCT04020107, 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 2 Apr 2026.