Nctid:
NCT06229704
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015837", "term"=>"Vestibular Diseases"}], "ancestors"=>[{"id"=>"D000007759", "term"=>"Labyrinth Diseases"}, {"id"=>"D000004427", "term"=>"Ear Diseases"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}], "browseLeaves"=>[{"id"=>"M17462", "name"=>"Vertigo", "relevance"=>"LOW"}, {"id"=>"M7420", "name"=>"Dizziness", "relevance"=>"LOW"}, {"id"=>"M18387", "name"=>"Vestibular Diseases", "asFound"=>"Vestibular Function Disorder", "relevance"=>"HIGH"}, {"id"=>"M10779", "name"=>"Labyrinth Diseases", "relevance"=>"LOW"}, {"id"=>"M10782", "name"=>"Labyrinthitis", "relevance"=>"LOW"}, {"id"=>"M7601", "name"=>"Ear Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2027-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-18", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-08", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"video Head Impulse Test (vHIT)", "timeFrame"=>"Measured at baseline and after 3 months of rehabilitation", "description"=>"Outcome measures: mean VOR gain"}, {"measure"=>"video Head Impulse Test (vHIT)", "timeFrame"=>"Measured at baseline and after 3 months of rehabilitation", "description"=>"Outcome measures: VOR gain asymmetry in percent (%)"}, {"measure"=>"video Head Impulse Test (vHIT)", "timeFrame"=>"Measured at baseline and after 3 months of rehabilitation", "description"=>"Outcome measures: description of saccades (overt and covert saccades)"}, {"measure"=>"Cervical Vestibular Evoked Myogenic Potential (cVEMP)", "timeFrame"=>"Measured at baseline", "description"=>"Outcome measures: latency P1 and latency N1 in milliseconds (ms)"}, {"measure"=>"Cervical Vestibular Evoked Myogenic Potential (cVEMP)", "timeFrame"=>"Measured at baseline", "description"=>"Outcome measures: rectified interpeak amplitude P1-N1"}, {"measure"=>"Cervical Vestibular Evoked Myogenic Potential (cVEMP)", "timeFrame"=>"Measured at baseline", "description"=>"Outcome measures: averaged EMG in μV"}, {"measure"=>"Cervical Vestibular Evoked Myogenic Potential (cVEMP)", "timeFrame"=>"Measured at baseline", "description"=>"Outcome measures: left-right asymmetry ratio in percent (%)"}, {"measure"=>"Ocular Vestibular Evoked Myogenic Potential (oVEMP)", "timeFrame"=>"Measured at baseline", "description"=>"Outcome measures: latency N1 and latency P1 in milliseconds"}, {"measure"=>"Ocular Vestibular Evoked Myogenic Potential (oVEMP)", "timeFrame"=>"Measured at baseline", "description"=>"Outcome measures: interpeak amplitude N1-P1 in μV"}, {"measure"=>"Ocular Vestibular Evoked Myogenic Potential (oVEMP)", "timeFrame"=>"Measured at baseline", "description"=>"Outcome measures: left-right asymmetry ratio in percent (%)"}, {"measure"=>"Computerized Dynamic Posturography (CDP)", "timeFrame"=>"Measured at baseline and after 3 months of rehabilitation", "description"=>"Outcome measures: Sensory Organization Test (SOT):\n\n* Average equilibrium score (ES) for SOT1-6. Equilibrium scores is the average of three trials for each of the six conditions SOT1-6.\n* The SOT Composite score. It is a weighted average of the six conditions (SOT1-6) with greater weight given to the more difficult conditions.\n* The preference score. The preference score = (SOT3 + SOT6) / (SOT2 + SOT5))."}, {"measure"=>"Computerized Dynamic Posturography (CDP)", "timeFrame"=>"Measured at baseline and after 3 months of rehabilitation", "description"=>"Outcome measures: Motor Control Test (MCT):\n\n• Mean latency of the medium and the big movement respectively in anterior and posterior direction measured in milliseconds."}, {"measure"=>"Computerized Dynamic Posturography (CDP)", "timeFrame"=>"Measured at baseline and after 3 months of rehabilitation", "description"=>"Outcome measures: for ADaptation Test (ADT):\n\n• Mean sway energy score of toes-up and toes-down respectively. The sway energy score quantifies the force magnitude required to overcome the postural instability."}], "secondaryOutcomes"=>[{"measure"=>"Vestibular dysfunction", "timeFrame"=>"Measured at baseline", "description"=>"Prevalence of vestibular dysfunction"}, {"measure"=>"Dizziness Handicap Inventory for patient caregivers (DHI-PC):", "timeFrame"=>"Measured at baseline and after 3 months of rehabilitation", "description"=>"Outcome measures: Mean total DHI-PC score. DHI-PC is a caregiver-reported 21-item questionnaire. 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."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Vestibular dysfunction", "Balance problem", "Children", "Dizziness", "Vestibular assessment", "video Head Impulse Test", "Vestibular Evoked Myogenic Potential", "Computerized Dynamic Posturography", "Delayed gross motor development"], "conditions"=>["Children, Only", "Vestibular Disorder", "Vestibular Function Disorder", "Development Delay"]}, "descriptionModule"=>{"briefSummary"=>"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/or with dizziness/balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.", "detailedDescription"=>"Balance problems in children are an overlooked issue in the Danish healthcare system. Dysfunction of the vestibular system, i.e. vestibular dysfunction (VD), can have significant consequences for children's development and quality of life.\n\nSeveral studies have shown that VD in infants may cause delayed gross motor development and milestones, such as head stabilization, sitting, and walking. Moreover, VD is found to have a negative impact on fine motor skills, reading, writing, and learning ability. Early diagnostics is important to reduce this latency and the negative impact on quality of life.\n\nThe investigators aim for a child friendly and reliable vestibular test protocol in the study. According to the investigators studies as well as international reports, the investigators have chosen a vestibular test protocol with Video Head Impulse Test (v-HIT), cervical and ocular Vestibular Evoked Myogenic Potential (c and oVEMP) as the tests are feasible, valid, and child friendly. To evaluate overall balance ability, the children are tested on a Computerized Dynamic Posturography.\n\nThe aim of the study is to investigate the vestibular function in children suspected of balance disorders, and to follow up on their balance progressions after rehabilitation.\n\nHypothesis: The investigators expect that delayed gross motor development and symptoms of dizziness and balance problems in some children are caused by VD. The investigators expect that early detection and rehabilitation by a physiotherapist will improve the balance ability for the child.\n\nMethods: The study is a prospective cohort study, with follow up after rehabilitation. Participants are children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/balance problems. The participants are recruited at The Pediatric Department at Gødstrup Hospital, Denmark. The investigators intend to include all consecutive children referred to the Department within one year. All participants will go through a test protocol consisting of questionnaires, hearing screening and vestibular and postural assessments.\n\nThe primary endpoints are results of v-HIT, c and oVEMP, and posturography, which are compared to normative values. The secondary endpoints are prevalence of vestibular dysfunction and chance in vestibular and postural test results after three months of rehabilitation and mean total Dizziness Handicap Inventory for patient caregivers (DHI-PC) score. A number of variables are collected such as demographics, developmental milestones, family history with focus on hearing and balance.\n\nData are collected at baseline and after three months of rehabilitation."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"10 years", "minimumAge"=>"6 months", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/balance problems are recruited at The Pediatric Department at Gødstrup Hospital, Denmark. We intend to include all consecutive children referred to the Department within one year, and who attend at least one follow up. We estimate to include 30 patients.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Children in the age of 6 months to 10 years\n* Delayed gross motor development and/or dizziness/balance 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)"}, "identificationModule"=>{"nctId"=>"NCT06229704", "acronym"=>"VASIC", "briefTitle"=>"Vestibular and Postural Function in Children Suspected of Balance Disorders", "organization"=>{"class"=>"OTHER", "fullName"=>"Gødstrup Hospital"}, "officialTitle"=>"Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)", "orgStudyIdInfo"=>{"id"=>"SFB-4-2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Children with delayed gross motor development and/or with dizziness/balance problems", "description"=>"Children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/balance problems are recruited at The Pediatric Department at Gødstrup Hospital, Denmark.", "interventionNames"=>["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"]}], "interventions"=>[{"name"=>"video Head Impulse Test", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["vHIT"], "description"=>"For v-HIT, the Synapsys v-HIT Ulmer device is used.", "armGroupLabels"=>["Children with delayed gross motor development and/or with dizziness/balance problems"]}, {"name"=>"Cervical Vestibular Evoked Myogenic Potential", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["cVEMP"], "description"=>"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.", "armGroupLabels"=>["Children with delayed gross motor development and/or with dizziness/balance problems"]}, {"name"=>"Ocular Vestibular Evoked Myogenic Potential", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["oVEMP"], "description"=>"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.", "armGroupLabels"=>["Children with delayed gross motor development and/or with dizziness/balance problems"]}, {"name"=>"Computerized Dynamic Posturography", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["CDP"], "description"=>"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.", "armGroupLabels"=>["Children with delayed gross motor development and/or with dizziness/balance problems"]}, {"name"=>"Dizziness Handicap Inventory for patient caregivers", "type"=>"OTHER", "otherNames"=>["DHI-PC"], "description"=>"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.", "armGroupLabels"=>["Children with delayed gross motor development and/or with dizziness/balance problems"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Signe F Bønløkke, PhD student", "role"=>"CONTACT", "email"=>"siband@rm.dk", "phone"=>"+45 41405064"}], "overallOfficials"=>[{"name"=>"Therese Ovesen, Professor", "role"=>"STUDY_CHAIR", "affiliation"=>"University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gødstrup Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Signe Fiil Bønløkke", "investigatorAffiliation"=>"Gødstrup Hospital"}}}}
