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Vestibular and Postural Function in Children Suspected of Balance Disorders (VASIC)

G

Gødstrup Hospital

Status

Begins enrollment in 5 months

Conditions

Vestibular Function Disorder
Development Delay
Children, Only
Vestibular Disorder

Treatments

Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential
Diagnostic Test: Computerized Dynamic Posturography
Other: Dizziness Handicap Inventory for patient caregivers
Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential
Diagnostic Test: video Head Impulse Test

Study type

Observational

Funder types

Other

Identifiers

NCT06229704
SFB-4-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

6 months to 10 years old

Volunteers

No Healthy Volunteers

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)

Trial design

30 participants in 1 patient group

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.
Treatment:
Other: Dizziness Handicap Inventory for patient caregivers
Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential
Diagnostic Test: video Head Impulse Test
Diagnostic Test: Computerized Dynamic Posturography
Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential

Trial contacts and locations

0

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Central trial contact

Signe F Bønløkke, PhD student

Data sourced from clinicaltrials.gov

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