Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-04 @ 12:55 AM
Study NCT ID:
NCT03359135
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Garments on Hypermobility Type of Ehlers-Danlos Syndrome (CGhEDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536196', 'term': 'Ehlers-Danlos syndrome type 3'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-11-27', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Centre of pression speed', 'timeFrame': '4 weeks', 'description': 'a stability parameter on a force plate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Compression garment'], 'conditions': ['Hypermobility Type Ehlers-Danlos Syndrome']}, 'referencesModule': {'references': [{'pmid': '37194618', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hypermobility type of Ehlers-Danlos syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥16 years\n* hEDS with the 2017 diagnostic criteria .\n* A normal neurological examination with no sensory disorders, no cerebellar syndrome or vestibular syndrome.\n* An optimal balanced analgesic treatment before inclusion\n* Patients who have not modified their physical treatment (physiotherapy) since 6 months.\n\nExclusion Criteria:\n\n* Surgery of the lower limb (hip, knee or ankle)\n* Patient having already wear compression garments in the year preceding.\n* Neurological history of sensory , vestibular or cerebellar disorders.'}, 'identificationModule': {'nctId': 'NCT03359135', 'acronym': 'VECO', 'briefTitle': 'Compression Garments on Hypermobility Type of Ehlers-Danlos Syndrome (CGhEDS)', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Raymond Poincaré'}, 'officialTitle': 'Compression Garments Effects on Postural Balance of Patients With Hypermobility Type of Ehlers-danlos Syndrome, a Prospective Study on 40 Patients', 'orgStudyIdInfo': {'id': 'hEDS-40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group1', 'description': 'hEDS treated with rehabilitation only', 'interventionNames': ['Other: Rehabilitation']}, {'label': 'group 2', 'description': 'hEDS treated with rehabilitation associated to compression garments wearing', 'interventionNames': ['Other: Rehabilitation', 'Device: Compression Garment']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': 'Rehabilitation during 4 weeks', 'armGroupLabels': ['group 2', 'group1']}, {'name': 'Compression Garment', 'type': 'DEVICE', 'description': 'Rehabilitation associated to wearing CG during 4 weeks', 'armGroupLabels': ['group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'contacts': [{'name': 'Nadra Gader', 'role': 'CONTACT', 'email': 'nadra.gd@gmail.com', 'phone': '0033788127902'}, {'name': 'Karelle Benistan', 'role': 'CONTACT', 'email': 'karelle.benistan@aphp.fr', 'phone': '0033147104440'}], 'facility': 'Gader Nadra', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'BENISTAN Karelle, Dr', 'role': 'CONTACT', 'email': 'karelle.benistan@aphp.fr', 'phone': '0033147104440'}, {'name': 'GADER Nadra, Dr', 'role': 'CONTACT', 'email': 'nadra.gd@gmail.com', 'phone': '0033788127902'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Raymond Poincaré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}