An observational study in Children, Only, Vestibular Disorder and Vestibular Function Disorder, sponsored by Gødstrup Hospital. Recruiting at 1 site in Denmark. Open to participants aged 6 Months to 10 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Gødstrup Hospital · Observational
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.
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.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's planned enrollment of 30 is below the median of 59 across 34 observational studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →Gødstrup Hospital is the lead sponsor of 24 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
For v-HIT, the Synapsys v-HIT Ulmer device is used.
Also known as: vHIT
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.
Also known as: cVEMP
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.
Also known as: oVEMP
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.
Also known as: CDP
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.
Also known as: DHI-PC
video Head Impulse Test (vHIT)
Outcome measures: mean VOR gain
Time frame: Measured at baseline and after 3 months of rehabilitation
video Head Impulse Test (vHIT)
Outcome measures: VOR gain asymmetry in percent (%)
Time frame: Measured at baseline and after 3 months of rehabilitation
video Head Impulse Test (vHIT)
Outcome measures: description of saccades (overt and covert saccades)
Time frame: Measured at baseline and after 3 months of rehabilitation
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Outcome measures: latency P1 and latency N1 in milliseconds (ms)
Time frame: Measured at baseline
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Outcome measures: rectified interpeak amplitude P1-N1
Time frame: Measured at baseline
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Outcome measures: averaged EMG in μV
Time frame: Measured at baseline
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Outcome measures: left-right asymmetry ratio in percent (%)
Time frame: Measured at baseline
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Outcome measures: latency N1 and latency P1 in milliseconds
Time frame: Measured at baseline
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Outcome measures: interpeak amplitude N1-P1 in μV
Time frame: Measured at baseline
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Outcome measures: left-right asymmetry ratio in percent (%)
Time frame: Measured at baseline
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)).
Time frame: Measured at baseline and after 3 months of rehabilitation
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.
Time frame: Measured at baseline and after 3 months of rehabilitation
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.
Time frame: Measured at baseline and after 3 months of rehabilitation
Vestibular dysfunction
Prevalence of vestibular dysfunction
Time frame: Measured at baseline
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.
Time frame: Measured at baseline and after 3 months of rehabilitation
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for Jan 2028, 29 months after the start.
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Gødstrup Hospital