Vestibular and Postural Function in Children Suspected of Balance Disorders

NCT06229704 | Recruiting

• 1 other identifier: SFB-4-2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (13)

• video Head Impulse Test (vHIT)

  Outcome measures: mean VOR gain

  Measured at baseline and after 3 months of rehabilitation

• video Head Impulse Test (vHIT)

  Outcome measures: VOR gain asymmetry in percent (%)

  Measured at baseline and after 3 months of rehabilitation

• video Head Impulse Test (vHIT)

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

  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)

  Measured at baseline

• Cervical Vestibular Evoked Myogenic Potential (cVEMP)

  Outcome measures: rectified interpeak amplitude P1-N1

  Measured at baseline

• Cervical Vestibular Evoked Myogenic Potential (cVEMP)

  Outcome measures: averaged EMG in μV

  Measured at baseline

• Cervical Vestibular Evoked Myogenic Potential (cVEMP)

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

  Measured at baseline

• Ocular Vestibular Evoked Myogenic Potential (oVEMP)

  Outcome measures: latency N1 and latency P1 in milliseconds

  Measured at baseline

• Ocular Vestibular Evoked Myogenic Potential (oVEMP)

  Outcome measures: interpeak amplitude N1-P1 in μV

  Measured at baseline

• Ocular Vestibular Evoked Myogenic Potential (oVEMP)

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

  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)).

  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.

  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.

  Measured at baseline and after 3 months of rehabilitation

Secondary Outcomes (2)

• Vestibular dysfunction

  Measured at baseline

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

  Measured at baseline and after 3 months of rehabilitation

Study Arms (1)

Children with delayed gross motor development and/or with dizziness/balance problems

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

Interventions

video Head Impulse Test DIAGNOSTIC_TEST

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

Also known as: vHIT

Children with delayed gross motor development and/or with dizziness/balance problems

Cervical Vestibular Evoked Myogenic Potential DIAGNOSTIC_TEST

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

Children with delayed gross motor development and/or with dizziness/balance problems

Ocular Vestibular Evoked Myogenic Potential DIAGNOSTIC_TEST

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

Children with delayed gross motor development and/or with dizziness/balance problems

Computerized Dynamic Posturography DIAGNOSTIC_TEST

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

Children with delayed gross motor development and/or with dizziness/balance problems

Dizziness Handicap Inventory for patient caregivers OTHER

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

Children with delayed gross motor development and/or with dizziness/balance problems

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gødstrup Hospital: lead

Study Sites (1)

Gødstrup Regional Hospital

Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Vestibular Diseases; Learning Disabilities; Dizziness

Interventions

Vestibular Evoked Myogenic Potentials

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

Evoked Potentials, Motor; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena

Study Officials

• Therese Ovesen, Professor

  University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK

  STUDY CHAIR

Central Study Contacts

Signe F Bønløkke, PhD student

CONTACT

+45 41405064; siband@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 29, 2024
• Study Start: August 20, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)