NCT04685746 BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development
| NCT ID | NCT04685746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Vestibular Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2019-07-29 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2019-07-29 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
When a vestibular dysfunction occurs at birth or in early stages of life, one might expect that this may have an enormous impact on a child's development. It is known that a severe congenital or early acquired vestibular deficit in children results in delayed psychomotor milestones. Later in life, children with a vestibular dysfunction may have difficulties with several balance tasks and additional cognitive, motor and/or psychosocial performances. While a few authors have suggested that there is indeed an influence of a vestibular dysfunction upon these different developmental domains (cognitive, motor, educational and psychosocial development), which can be supported by findings in clinical practice as well, literature concerning this topic remains fairly limited. On the other hand, several studies have shown that children with known difficulties in motor and/or cognitive functions have more difficulties in vestibular performances in comparison with their unaffected peers. Although more frequently discussed, the literature on this population is rather scarce too. Therefore, the current project aims to investigate the relationship with and the involvement of the vestibular system in the motor and cognitive development of school-aged children.
Eligibility Criteria
For typically developing children Exclusion Criteria: * Having a (permanent) hearing loss * Having a (permanent) vestibular loss * Having a motor dysfunction * IQ \< 70 For vestibular-impaired children Inclusion Criteria: * Recently (\< 6 months) tested at the Ghent University Hospital * Diagnosed with a vestibular impairment (= alteration on at least one of the vestibular function tests: caloric, rotatory chair, vHIT, cVEMP and/or oVEMP test) For neurodevelopmental group Inclusion Criteria: • Diagnosed by a (neuro)psychiatric team with Autism Spectrum Disorder, Attention deficit/Hyperactivitiy Disorder and/or Developmental Coordination Disorder
Contact & Investigator
Leen Maes, PhD
PRINCIPAL INVESTIGATOR
Ghent University and Ghent University Hospital
Frequently Asked Questions
Who can join the NCT04685746 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 13 Years, studying Vestibular Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04685746 currently recruiting?
Yes, NCT04685746 is actively recruiting participants. Contact the research team at ruth.vanhecke@ugent.be for enrollment information.
Where is the NCT04685746 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT04685746 clinical trial?
NCT04685746 is sponsored by University Ghent. The principal investigator is Leen Maes, PhD at Ghent University and Ghent University Hospital. The trial plans to enroll 250 participants.