NCT04117620

Brief Summary

There is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 28, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

October 3, 2019

Last Update Submit

September 8, 2025

Conditions

Keywords

Pediatric vestibular symptomPediatric vestibular symptom questionnaire in french

Outcome Measures

Primary Outcomes (4)

  • Reproducibility

    Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.

    1 year

  • Consistency reliability test

    Measure of efficiency. Comparison of questionnaires completed by patients and controls.

    1 year

  • Item-total Pearson correlation

    Measure of efficiency. Comparison of questionnaires completed by patients and controls.

    1 year

  • Principal components analysis

    Measure of efficiency. Comparison of questionnaires completed by patients and controls.

    1 year

Study Arms (2)

Patients

Patients from 7 to 17 years of age with vestibular deficiency.

Other: Pediatric Vestibular Symptom Questionnaire

Controls

Subjects from 7 to 17 years of age without vestibular deficiency

Other: Pediatric Vestibular Symptom Questionnaire

Interventions

Subjects respond to the translated questionnaire twice with 15 days interval

Also known as: Patient questionnaire
ControlsPatients

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.

You may qualify if:

  • Non-opposition of the holders of parental authority and the subject to participation in the study
  • Subjects between 7 and 17 years of age
  • Patients : patients followed in the clinic at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery and presenting with dizziness without associated ophthalmological or neurological disorder.

You may not qualify if:

  • \- Absence of diagnosis after etiological assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • Rigal T, Parodi M, Brisse F, Denoyelle F, Loundon N, Simon F. Translation and validation of the PVSQ and DHI-PC questionnaires for pediatric dizziness. Eur Ann Otorhinolaryngol Head Neck Dis. 2024 Jan;141(1):5-12. doi: 10.1016/j.anorl.2023.05.001. Epub 2023 May 22.

    PMID: 37225531BACKGROUND

MeSH Terms

Conditions

Dizziness

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • François Simon, MD MSc

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

April 28, 2020

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations