Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT04714632
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vestibular evoked myogenic potentials', 'timeFrame': 'up to 6 months', 'description': 'To evaluate the results of vestibular evoked myogenic potentials we used the latency (ms) and the amplitude (μV) of the positive wave (P13) and the negative wave (N23)'}, {'measure': 'Posturography', 'timeFrame': 'up to 6 months', 'description': 'Posturography was measured in 6 different sensory conditions. The posturographic parameters of center of pressure were measured for this study.'}, {'measure': 'Perception of subjective visual vertical', 'timeFrame': 'up to 6 months', 'description': 'We measured perception of subjective visual vertical (SVV) in static and dynamic conditions. Each participant completed a total of six trials for static SVV and twelve trials for dynamic SVV, in six trials the optokinetic background rotated clockwise and in six trials counterclockwise. Norms for static conditions are ±2° and for dynamic conditions ±4°'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['idiopathic scoliosis', 'subjective visual vertical', 'vestibular evoked myogenic potentials', 'posturography'], 'conditions': ['Idiopathic Scoliosis', 'Vestibular Abnormality']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate vestibular function in children with idiopathic scoliosis as a possible cause of etiopathogenesis of its diagnose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with Idiopathic scoliosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* idiopathic scoliosis\n\nExclusion Criteria:\n\n* operation of the spine\n* neurological disease\n* hearing problems'}, 'identificationModule': {'nctId': 'NCT04714632', 'briefTitle': 'Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Vestibular Function in Adolescents With Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '260119'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with idiopathic scoliosis', 'description': 'Adolescent between 10-18y with diagnosing idiopathic scoliosis'}, {'label': 'Healthy children', 'description': 'Healthy children between 10-18y without any orthopedics problems'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Department of Rehabilitation and Sports Medicine, University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master of science', 'investigatorFullName': 'Klara Kucerova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}