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Children, OnlyVASICNCT06229704

Vestibular and Postural Function in Children Suspected of Balance Disorders

An observational study of Children, Only and Vestibular Disorder, run by Gødstrup Hospital at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 10 years
What is being tested?
video Head Impulse Test, Cervical Vestibular Evoked Myogenic Potential and Ocular Vestibular Evoked Myogenic Potential
How many people
30 participants
Where
1 siteDenmark
Study dates
20 Aug 2025to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 10 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Signe F Bønløkke, PhD student contact

+45 41405064

siband@rm.dk

Denmark1 site, 1 recruiting
  • Gødstrup Regional Hospital

    Herning, 7400

    Signe F Bønløkke, PhD student, siband@rm.dk

    Recruiting

Other trials in Denmark

About this study

Official title: Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)

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.

Read the 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.

Being tested
video Head Impulse Test, Cervical Vestibular Evoked Myogenic Potential, Ocular Vestibular Evoked Myogenic Potential, Computerized Dynamic Posturography, Dizziness Handicap Inventory for patient caregivers
Keywords
Vestibular dysfunction, Balance problem, Children, Dizziness, Vestibular assessment, video Head Impulse Test, Vestibular Evoked Myogenic Potential, Computerized Dynamic Posturography, Delayed gross motor development
Medical subject headings
Vestibular Diseases, Learning Disabilities, Dizziness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video Head Impulse TestDiagnostic test

    Also called vHIT

    For v-HIT, the Synapsys v-HIT Ulmer device is used.

  • Cervical Vestibular Evoked Myogenic PotentialDiagnostic test

    Also called cVEMP

    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.

  • Ocular Vestibular Evoked Myogenic PotentialDiagnostic test

    Also called oVEMP

    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.

  • Computerized Dynamic PosturographyDiagnostic test

    Also called CDP

    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.

  • Dizziness Handicap Inventory for patient caregiversOther

    Also called DHI-PC

    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.

Study groups in NCT06229704
Study groupRoleWhat they receive
Children with delayed gross motor development and/or with dizziness/balance problemsChildren 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. video Head Impulse Test (vHIT)

    Outcome measures: mean VOR gain

    Measured: Measured at baseline and after 3 months of rehabilitation

  2. video Head Impulse Test (vHIT)

    Outcome measures: VOR gain asymmetry in percent (%)

    Measured: Measured at baseline and after 3 months of rehabilitation

  3. video Head Impulse Test (vHIT)

    Outcome measures: description of saccades (overt and covert saccades)

    Measured: Measured at baseline and after 3 months of rehabilitation

  4. Cervical Vestibular Evoked Myogenic Potential (cVEMP)

    Outcome measures: latency P1 and latency N1 in milliseconds (ms)

    Measured: Measured at baseline

  5. Cervical Vestibular Evoked Myogenic Potential (cVEMP)

    Outcome measures: rectified interpeak amplitude P1-N1

    Measured: Measured at baseline

  6. Cervical Vestibular Evoked Myogenic Potential (cVEMP)

    Outcome measures: averaged EMG in μV

    Measured: Measured at baseline

  7. Cervical Vestibular Evoked Myogenic Potential (cVEMP)

    Outcome measures: left-right asymmetry ratio in percent (%)

    Measured: Measured at baseline

  8. Ocular Vestibular Evoked Myogenic Potential (oVEMP)

    Outcome measures: latency N1 and latency P1 in milliseconds

    Measured: Measured at baseline

  9. Ocular Vestibular Evoked Myogenic Potential (oVEMP)

    Outcome measures: interpeak amplitude N1-P1 in μV

    Measured: Measured at baseline

  10. Ocular Vestibular Evoked Myogenic Potential (oVEMP)

    Outcome measures: left-right asymmetry ratio in percent (%)

    Measured: Measured at baseline

  11. Computerized Dynamic Posturography (CDP)

    Outcome measures: Sensory Organization Test (SOT):

    • Average equilibrium score (ES) for SOT1-6. Equilibrium scores is the average of three trials for each of the six conditions SOT1-6.
    • The SOT Composite score. It is a weighted average of the six conditions (SOT1-6) with greater weight given to the more difficult conditions.
    • The preference score. The preference score = (SOT3 + SOT6) / (SOT2 + SOT5)).

    Measured: Measured at baseline and after 3 months of rehabilitation

  12. Computerized Dynamic Posturography (CDP)

    Outcome measures: Motor Control Test (MCT):

    • Mean latency of the medium and the big movement respectively in anterior and posterior direction measured in milliseconds.

    Measured: Measured at baseline and after 3 months of rehabilitation

  13. Computerized Dynamic Posturography (CDP)

    Outcome measures: 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.

    Measured: Measured at baseline and after 3 months of rehabilitation

Secondary outcomes (2)
  1. Vestibular dysfunction

    Prevalence of vestibular dysfunction

    Measured: Measured at baseline

  2. Dizziness Handicap Inventory for patient caregivers (DHI-PC):

    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.

    Measured: Measured at baseline and after 3 months of rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start20 Aug 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06229704
Sponsor's protocol ID
SFB-4-2023
Acronym
VASIC
Status last verified
Sep 2026
First submitted
8 Jan 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Children, Only and Vestibular Disorder, run by Gødstrup Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Signe F Bønløkke, PhD student (+45 41405064, siband@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

video Head Impulse Test (vHIT) (time frame: Measured at baseline and after 3 months of rehabilitation). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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