Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-03-13 @ 3:38 AM
Study NCT ID:
NCT03668561
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10-meter walk test (in seconds)', 'timeFrame': 'comparison between baseline and 15 days', 'description': 'Maximum gait velocity, from a standing start'}], 'secondaryOutcomes': [{'measure': 'Assessment of gait temporospatial parameters by GaitRite®', 'timeFrame': 'comparison between baseline and 15 days', 'description': 'Specific temporal and spatial parameters of gait will be measured with the GaitRite gait evaluation system: gait cadence, hemiparetic step length, spatial asymmetry, swing and stance times.'}, {'measure': 'Posturographic analysis during static upright stance (center of pressure surface)', 'timeFrame': 'comparison between baseline and 15 days', 'description': 'Assessment of displacements of the center of pressure during quiet upright standing for 30s, using a Zebris platform'}, {'measure': 'Baropodometric analysis during gait', 'timeFrame': 'comparison between baseline and 15 days', 'description': 'Assessment of the paretic footprint during gait, using the Zebris platform'}, {'measure': 'Gait endurance (2-minute walk test)', 'timeFrame': 'comparison between baseline and 15 days', 'description': 'Assessment of maximum gait perimeter during a 2mwt'}, {'measure': 'Assessment of walking function', 'timeFrame': 'comparison between baseline and 15 days', 'description': 'Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores'}, {'measure': 'Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale', 'timeFrame': 'at 15 days', 'description': 'visual analog scale (0=major discomfort - 10=excellent comfort)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'hemiplegia'], 'conditions': ['Hemiparesis', 'Varus Deformity of Equine Carpus']}, 'descriptionModule': {'briefSummary': 'To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiparesis at \\> 3 months (whatever the etiology)\n* varus or equinovarus foot disturbing the stance phase of gait\n* Able to walk at least 10m, with or without assistive device\n\nExclusion Criteria:\n\n* unable to walk 10m\n* Botulinum toxin injection less than 3 months before inclusion\n* history of neurological or locomotor pathology in addition to the etiology of hemiparesis\n* Severe comprehension troubles\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03668561', 'acronym': 'CALIGALOC', 'briefTitle': 'the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus', 'orgStudyIdInfo': {'id': '2017_01'}, 'secondaryIdInfos': [{'id': '2017-A02098-45', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (CALIGALOC)', 'description': 'Wearing of the Caligaloc orthosis', 'interventionNames': ['Device: Caligaloc']}], 'interventions': [{'name': 'Caligaloc', 'type': 'DEVICE', 'description': '15 days of wearing of the Caligaloc orthosis', 'armGroupLabels': ['Treatment (CALIGALOC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne Allart, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Swynghedau, CHI', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Etienne Allart, MD', 'role': 'CONTACT', 'email': 'etienne.allart@chru-lille.fr', 'phone': '3 20 44 48 71', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Etienne Allart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}