Normative Data of Vestibular and Postural Function in Danish Children
- Conditions
- Children, OnlyVestibular Function
- Interventions
- Diagnostic Test: video Head Impulse TestDiagnostic Test: Cervical Vestibular Evoked Myogenic PotentialDiagnostic Test: Ocular Vestibular Evoked Myogenic PotentialDiagnostic Test: Computerized Dynamic PosturographyOther: Dizziness Handicap Inventory for patient caregivers
- Registration Number
- NCT06229730
- Lead Sponsor
- Gødstrup Hospital
- Brief Summary
The goal of this age-based cohort study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics. The participants will be children in the age of 6 months to 10 years, without any known hearing or balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.
- Detailed Description
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.
Knowledge about the prevalence of vestibular impairment and normative data of vestibular function in the Danish pediatric population is missing.
The 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.
The aim of the study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics.
Methods: The study is an age-based cohort study. Participants are children in the age of 6 months to 10 years, without any known hearing or balance problems. The participants are recruited in local nurseries, kinder gardens, and schools. All participants will go through a test protocol consisting of questionnaires, hearing screening and vestibular and postural assessments.
The primary endpoints are age-based norms for v-HIT, c and oVEMP, and posturographic results. The secondary endpoints are number of subjects with successful results of the vestibular test protocol 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Children in the age of 6 months -10 years
- Normal hearing
- No history of dizziness or balance problems
- Written informed consent from the parents.
- Premature birth
- Existing or previous inner ear disease(s) or previous inner ear surgery
- Cholesteatoma or previous middle ear surgery
- Known or previous vestibular disorder (Vestibular schwannoma, Mb Meniere, vestibular neuritis or other known)
- Delayed gross motor development evaluated through milestones.
- Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.
- Congenital nystagmus
- Compromised eye muscle mobility
- A diagnose of any neurological disease.
- A diagnose of any psychiatric disease.
- VEMP-electrode allergy
- History of symptomatic head or neck trauma
- Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy children without hearing or balance problems Ocular Vestibular Evoked Myogenic Potential Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools. Healthy children without hearing or balance problems video Head Impulse Test Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools. Healthy children without hearing or balance problems Dizziness Handicap Inventory for patient caregivers Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools. Healthy children without hearing or balance problems Computerized Dynamic Posturography Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools. Healthy children without hearing or balance problems Cervical Vestibular Evoked Myogenic Potential Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.
- Primary Outcome Measures
Name Time Method Cervical Vestibular Evoked Myogenic Potential (cVEMP): Measured at baseline. Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)
video Head Impulse Test (vHIT) Measured at baseline. Outcome measures: Description of saccades (overt and covert saccades)
Ocular Vestibular Evoked Myogenic Potential (oVEMP): Measured at baseline. Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)
Computerized Dynamic Posturography (CDP) Measured at baseline. Outcome measures: Aged-based norms for adaptation test (ADT):
• 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.
- Secondary Outcome Measures
Name Time Method Dizziness Handicap Inventory for patient caregivers (DHI-PC): Measured at baseline. 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.
Success rate of the vestibular test protocol Measured at baseline Number of subjects with successful results of each of the vestibular assessments.