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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04117620
Other study ID # APHP190616
Secondary ID ID RCB : 2019-A0
Status Completed
Phase
First received
Last updated
Start date April 28, 2020
Est. completion date April 28, 2021

Study information

Verified date May 2023
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Balance disorders are the most common cause of dizziness in children with a prevalence of 0.7 to 15%. Vestibular migraine, benign paroxysmal positional vertigo of the child, post-concussion dizziness as a result of cranial trauma, and viral vestibular neuritis are the most common causes. However, these disorders are often undiagnosed in children as many doctors may attribute these symptoms to behavioural disorders or clumsiness. This is probably because of the difficulty children may have in expressing or describing their dizziness symptoms without specific questioning, but also because of the tendency of children to accept the terminology that an adult offers them or even tend to cling to their parents when they experience a balance disorder or vertigo. Vestibular disorders can also have secondary psychological symptoms with an impact on school learning and quality of life. A precise interrogation to check the symptoms, to look for the triggers and to trace the installation of the symptoms is fundamental to diagnose and make a therapeutic decision. Thus, it is very important to help the child express his or her feelings by proposing different descriptions and formulations to determine the etiology and diagnosis. While a number of international questionnaires validated and translated into French exist in the adult to assess the presence, severity and impact of vestibular symptoms, 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date April 28, 2021
Est. primary completion date April 28, 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria: - 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. - Controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background. Exclusion Criteria: - Absence of diagnosis after etiological assessment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pediatric Vestibular Symptom Questionnaire
Subjects respond to the translated questionnaire twice with 15 days interval

Locations

Country Name City State
France AP-HP, Hôpital Necker-Enfants Malades Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. 2023 May 22:S1879-7296(23)00072-8. doi: 10.1016/j.anorl.2023.05 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reproducibility Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test. 1 year
Primary Consistency reliability test Measure of efficiency. Comparison of questionnaires completed by patients and controls. 1 year
Primary Item-total Pearson correlation Measure of efficiency. Comparison of questionnaires completed by patients and controls. 1 year
Primary Principal components analysis Measure of efficiency. Comparison of questionnaires completed by patients and controls. 1 year
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