[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533737":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":50,"centralContacts":55,"locations":61,"responsibleParty":77,"collaborators":10,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":10,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Gødstrup Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children with delayed gross motor development and\u002For with dizziness\u002Fbalance problems",null,"Children in the age of 6 months to 10 years with delayed gross motor development and\u002For with dizziness\u002Fbalance problems are recruited at The Pediatric Department at Gødstrup Hospital, Denmark.",[13,14,15,16,17],"Diagnostic Test: video Head Impulse Test","Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential","Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential","Diagnostic Test: Computerized Dynamic Posturography","Other: Dizziness Handicap Inventory for patient caregivers",[19,26,32,38,44],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","video Head Impulse Test","For v-HIT, the Synapsys v-HIT Ulmer device is used.",[9],[25],"vHIT",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Cervical Vestibular Evoked Myogenic Potential","For cVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.",[9],[31],"cVEMP",{"type":20,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Ocular Vestibular Evoked Myogenic Potential","For oVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.",[9],[37],"oVEMP",{"type":20,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Computerized Dynamic Posturography","To evaluate functional balance of the children and the relative contributions of the vision, proprioception, and vestibular system a CDP from Virtualis (Virtualis, Montpellier, France) is used.",[9],[43],"CDP",{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Dizziness Handicap Inventory for patient caregivers","DHI is a caregiver-reported 21- item questionnaire. It is designed to evaluate the perceived quality of life and handicap resulting from dizziness and unsteadiness for the pediatric population. For each question there are three possible answers: yes, sometimes or no. Each answer provides respectively 4, 2 and 0 points. The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap. Scores under 16 are characterized as no limitation or handicap. A score from 16-26 present a mild perceived handicap and mild limitations. A DHI-score between 26-43 is classified as a moderate problem, and a score above 43 describes a severe perceived handicap and severe limitations.",[9],[49],"DHI-PC",[51],{"name":52,"affiliation":53,"role":54},"Therese Ovesen, Professor","University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK","STUDY_CHAIR",[56],{"name":57,"role":58,"phone":59,"phoneExt":10,"email":60},"Signe F Bønløkke, PhD student","CONTACT","+45 41405064","siband@rm.dk",[62],{"facility":63,"status":64,"city":65,"state":10,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Gødstrup Regional Hospital","RECRUITING","Herning","7400","Denmark","DK",{"type":70,"coordinates":71},"Point",[72,73],8.97662,56.13615,{"lat":73,"lon":72},[76],{"name":57,"role":58,"phone":10,"phoneExt":10,"email":60},{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Signe Fiil Bønløkke","Principal Investigator","100533737","vestibular-and-postural-function-in-children-suspected-of-balance-disorders-100533737",false,"NCT06229704","Vestibular and Postural Function in Children Suspected of Balance Disorders","Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)","VASIC","Inclusion Criteria:\n\n* Children in the age of 6 months to 10 years\n* Delayed gross motor development and\u002For dizziness\u002Fbalance problems.\n* Written informed consent from the parents.\n\nExclusion Criteria:\n\n* Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.\n* Congenital nystagmus\n* Compromised eye muscle mobility\n* VEMP-electrode allergy\n* History of symptomatic head or neck trauma\n* Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)","ALL","6 Months","10 Years",{"count":93,"type":94},30,"ESTIMATED","OBSERVATIONAL","The goal of this prospective cohort study is to investigate the vestibular function in children suspected of balance disorders, and to follow up on their balance progressions after rehabilitation. The main hypothesis of the study is that delayed gross motor development and symptoms of dizziness and balance problems in some children are caused by vestibular dysfunction. The investigators expect that early detection and rehabilitation by a physiotherapist will improve the balance ability for the child. The participants will be children in the age of 6 months to 10 years with delayed gross motor development and\u002For with dizziness\u002Fbalance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.",[98,99,100,101],"Children, Only","Vestibular Disorder","Vestibular Function Disorder","Development Delay",[103,104,105,106,107,21,108,39,109],"Vestibular dysfunction","Balance problem","Children","Dizziness","Vestibular assessment","Vestibular Evoked Myogenic Potential","Delayed gross motor development","2025-08-21",{"date":112,"type":113},"2025-08-26","ACTUAL",{"date":115,"type":113},"2025-08-20",{"date":117,"type":94},"2028-12",{"name":5,"class":6},1]