Vestibular and Postural Function in Children Suspected of Balance Disorders

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

August 20, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

December 31, 2028

Conditions
Children, OnlyVestibular DisorderVestibular Function DisorderDevelopment Delay
Interventions
DIAGNOSTIC_TEST

video Head Impulse Test

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

DIAGNOSTIC_TEST

Cervical Vestibular Evoked Myogenic Potential

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.

DIAGNOSTIC_TEST

Ocular Vestibular Evoked Myogenic Potential

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.

DIAGNOSTIC_TEST

Computerized Dynamic Posturography

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.

OTHER

Dizziness Handicap Inventory for patient caregivers

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.

Trial Locations (1)

7400

RECRUITING

Gødstrup Regional Hospital, Herning

All Listed Sponsors
lead

Gødstrup Hospital

OTHER

NCT06229704 - Vestibular and Postural Function in Children Suspected of Balance Disorders | Biotech Hunter | Biotech Hunter