Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome
NCT ID: NCT03986229
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2019-04-10
2022-03-15
Brief Summary
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The purpose of this study is to quantify the effect of CG on standing static balance in patients with EDS.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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With compression garments
Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.
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.
Without compression garments
Evaluation of the variation in the travel speed of the "center of pressure" with compression garments and the standing static balance.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Thomas Van Den Bossche
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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Service de Medecine physique et réadaptation
Toulouse, Salies Du Salat, France
Countries
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Other Identifiers
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RC31/18/0360
Identifier Type: -
Identifier Source: org_study_id