Clinical trial NCT06229704: Vestibular and Postural Function in Children Suspected of Balance Disorders
Official title: Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Children, Only
Vestibular Disorder
Vestibular Function Disorder
Development Delay
Keywords: Vestibular dysfunction
Balance problem
Children
Dizziness
Vestibular assessment
video Head Impulse Test
Vestibular Evoked Myogenic Potential
Computerized Dynamic Posturography
Delayed gross motor development
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Several 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.

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 investigate the vestibular function in children suspected of balance disorders, and to follow up on their balance progressions after rehabilitation.

Hypothesis: 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.

Methods: 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.

The 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.

Data are collected at baseline and after three months of rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Children in the age of 6 months to 10 years
* Delayed gross motor development and/or dizziness/balance problems.
* Written informed consent from the parents.

Exclusion Criteria:

* 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
* VEMP-electrode allergy
* History of symptomatic head or neck trauma
* Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)

Primary outcomes:
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline and after 3 months of rehabilitation
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline and after 3 months of rehabilitation
measure: video Head Impulse Test (vHIT)
timeFrame: Measured at baseline and after 3 months of rehabilitation
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP)
timeFrame: Measured at baseline
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP)
timeFrame: Measured at baseline
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP)
timeFrame: Measured at baseline
measure: Cervical Vestibular Evoked Myogenic Potential (cVEMP)
timeFrame: Measured at baseline
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP)
timeFrame: Measured at baseline
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP)
timeFrame: Measured at baseline
measure: Ocular Vestibular Evoked Myogenic Potential (oVEMP)
timeFrame: Measured at baseline
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline and after 3 months of rehabilitation
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline and after 3 months of rehabilitation
measure: Computerized Dynamic Posturography (CDP)
timeFrame: Measured at baseline and after 3 months of rehabilitation
Secondary outcomes:
measure: Vestibular dysfunction
timeFrame: Measured at baseline
measure: Dizziness Handicap Inventory for patient caregivers (DHI-PC):
timeFrame: Measured at baseline and after 3 months of rehabilitation
Other outcomes:
Locations:
Study officials:
affiliation: University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK
name: Therese Ovesen, Professor
role: STUDY_CHAIR
References: