Ehlers-Danlos SyndromeEDSNCT03986229
Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
A study testing Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments. in people with Ehlers-Danlos Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Studies have shown the existence of a proprioceptive deficit in patients with Ehlers Danlos Syndrome (EDS) (genetic pathology of connective tissue with hypermobility, multifactor joint instability). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome
- What is being tested?
- Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2019to 15 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EDS patients over 18 years of age walking around without technical assistance.
- Patients will need to be diagnosed both during the interview (presence of a family history, hypermobility and joint instability that has been evolving for years) and with a guide for analysis from EDS to AP-HP.
- Beighton's score must be 5/9 or higher.
- Free from any other pathology likely to have an impact on the balance.
- Patient with a CG as part of his or her management of the EDS
- Sufficient understanding to understand the objectives of the study and give consent.
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- Patient affiliated or benefiting from a social security scheme
- Allergies to one of the components (Polyamide and Elastane) of the CG
- Recent compression garments less than 6 months old.
Who cannot join
- Patient under guardianship, curators, justice protection.
- Comorbidity likely to influence balance.
- Significant pain (assessed by the patient) induced by the use of CG.
- Any acute event requires the postponement of the assessment to ensure that the patient's progress is in the usual conditions.
- Any acute pathology having an impact on the musculoskeletal system and/or general condition.
- Pregnancy/breastfeeding
- Compression garments over 6 months old.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Medecine physique et réadaptation
Toulouse, Salies Du Salat, 31260
About this study
Studies have shown the existence of a proprioceptive deficit in patients with Ehlers Danlos Syndrome (EDS) (genetic pathology of connective tissue with hypermobility, multifactor joint instability). A study dating from 2010 showed a qualitative improvement in disability when wearing compression garments (CG) in this pathology, particularly in the fields of proprioception and balance.
The purpose of this study is to quantify the effect of CG on standing static balance in patients with EDS.
Read the detailed description
To evaluate the effect of CG on standing static balance in patients with EDS, this study is a pilot study, carried out according to a cross-over scheme of type AB/BA.
Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B). Patients will be randomly assigned to 2 groups: the AB or BA sequence will be randomized for each patient.
For each evaluation, a measurement with eyes open and eyes closed will be performed.
A clinical balance assessment by the Berg test will be performed for each of the conditions.
- Conditions
- Ehlers-Danlos Syndrome
- Being tested
- Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.
- Keywords
- ehlers-danlos syndrome, static balance, custom compression garments
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.Other
Each evaluation will be done according to the following protocol:
- Evaluation of the pain
- Berg test
- One test per condition starting with open eyes
- Standardized instructions:
- Break about 15 minutes (wash-out) between each test.
- Both conditions will be tested on the same day.
- Evaluation in an environment free from visual and audible interference.
| Study group | Role | What they receive |
|---|---|---|
| With compression garments | Active comparator | Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance. Receives: Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments. |
| Without compression garments | Active comparator | Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance. Receives: Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments
Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).
Measured: 15 minutes
Evaluate the variation in the travel speed of the "center of pressure" without compression garments.
Evaluate the variation in the travel speed of the "center of pressure" without compression garments. Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).
Measured: 30 minutes
Secondary outcomes (2)
Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments
Evaluate the amplitude of the antero-posterior and lateral oscillations of the COP with and without compression garments Compare the stabilometric data with a clinical trial evaluating the reference balance.
Measured: 15 minutes
Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments
Evaluate the amplitude of the antero-posterior and lateral oscillations of the COP with and without compression garments.
Compare the stabilometric data with a clinical trial evaluating the reference balance.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start10 Apr 2019
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 15 patients exposed to the AB sequence and 15 patients exposed to the BA sequence
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Van Den Bossche, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986229
- Sponsor's protocol ID
- RC31/18/0360
- Acronym
- EDS
- Status last verified
- Dec 2022
- First submitted
- 11 Jun 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
- ClinicalTrials.gov ID
- NCT03986229
- Acronym / sponsor ID
- EDS / RC31/18/0360
- Conditions
- Ehlers-Danlos Syndrome
- Keywords
- ehlers-danlos syndrome, static balance, custom compression garments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 14 Jun 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.
Studies have shown the existence of a proprioceptive deficit in patients with Ehlers Danlos Syndrome (EDS) (genetic pathology of connective tissue with hypermobility, multifactor joint instability). A study dating from 2010 showed a qualitative improvement in disability when wearing compression garments (CG) in this pathology, particularly in the fields of proprioception and balance.
The purpose of this study is to quantify the effect of CG on standing static balance in patients with EDS.
Detailed description
To evaluate the effect of CG on standing static balance in patients with EDS, this study is a pilot study, carried out according to a cross-over scheme of type AB/BA.
Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B). Patients will be randomly assigned to 2 groups: the AB or BA sequence will be randomized for each patient.
For each evaluation, a measurement with eyes open and eyes closed will be performed.
A clinical balance assessment by the Berg test will be performed for each of the conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 15 patients exposed to the AB sequence and 15 patients exposed to the BA sequence
| Arm | Type | Receives |
|---|---|---|
| With compression garments | Active comparator | Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance. |
| Without compression garments | Active comparator | Other: Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- EDS patients over 18 years of age walking around without technical assistance.
- Patients will need to be diagnosed both during the interview (presence of a family history, hypermobility and joint instability that has been evolving for years) and with a guide for analysis from EDS to AP-HP.
- Beighton's score must be 5/9 or higher.
- Free from any other pathology likely to have an impact on the balance.
- Patient with a CG as part of his or her management of the EDS
Key exclusion criteria (7 listed)
- Patient under guardianship, curators, justice protection.
- Comorbidity likely to influence balance.
- Significant pain (assessed by the patient) induced by the use of CG.
- Any acute event requires the postponement of the assessment to ensure that the patient's progress is in the usual conditions.
- Any acute pathology having an impact on the musculoskeletal system and/or general condition.
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 |
|---|---|---|
| Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments.Each evaluation will be done according to the following protocol: * Evaluation of the pain * Berg test * One test per condition starting with open eyes * Standardized instructions: * Break about 15 minutes (wash-out) between each test. * Both conditions will be tested on the same day. * Evaluation in an environment free from visual and audible interference. | Other | With compression garments, Without compression garments |
Primary outcome
Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments
Time frame: 15 minutes
Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).
Evaluate the variation in the travel speed of the "center of pressure" without compression garments.
Time frame: 30 minutes
Evaluate the variation in the travel speed of the "center of pressure" without compression garments. Each patient will benefit from 2 posturological evaluations, namely without CG (treatment A) and with CG (treatment B).
2 secondary outcomes
Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments
Time frame: 15 minutes
Evaluate the amplitude of the antero-posterior and lateral oscillations without compression garments
Time frame: 30 minutes
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 15 Dec 2022.
- 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.
Thomas Van Den Bossche principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluate the variation in the travel speed of the "center of pressure" with and without compression garments. in people with Ehlers-Danlos Syndrome, run by University Hospital, Toulouse 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 9 inclusion and 7 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 15 Dec 2022. 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?
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?
Evaluate the variation in the travel speed of the "center of pressure" (COP) with compression garments (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.