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BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development

NCT ID: NCT04685746

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-29

Study Completion Date

2028-10-31

Brief Summary

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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.

Detailed Description

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General goals

1. Developing and standardizing a sensitive and specific test protocol for the detection of vestibular, cognitive and/or motor dysfunctions in school-aged children.
2. Investigate the relationship with and the involvement of the vestibular system in the motor and cognitive development of typically developing school-aged children.
3. Investigating whether a vestibular dysfunction (with/without an additional auditory disease) has an impact on motor and/or cognitive performances in school-aged children.
4. Investigating if in children with a known neurodevelopmental disorder an (additional) underlying vestibular dysfunction can be identified.

Conditions

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Vestibular Disorder Neurodevelopmental Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Typically developing school-aged children

Study group to achieve objective 1 and 2; control group to achieve objective 3 and 4 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments

Balanced Growth Protocol

Intervention Type BEHAVIORAL

Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks

Vestibular-impaired school-aged children

Study group to achieve objective 3 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments

Balanced Growth Protocol

Intervention Type BEHAVIORAL

Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks

Neurodevelopmental group (ADHD, ASD and/or DCD)

Study group to achieve objective 4 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments

Balanced Growth Protocol

Intervention Type BEHAVIORAL

Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks

Interventions

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Balanced Growth Protocol

Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


• Diagnosed by a (neuro)psychiatric team with Autism Spectrum Disorder, Attention deficit/Hyperactivitiy Disorder and/or Developmental Coordination Disorder

Exclusion Criteria

* Having a (permanent) hearing loss
* Having a (permanent) vestibular loss
* Having a motor dysfunction
* IQ \< 70

For vestibular-impaired children
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leen Maes, PhD

Role: PRINCIPAL_INVESTIGATOR

Ghent University and Ghent University Hospital

Locations

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Ghent University, department rehabilitation sciences

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Ruth Van Hecke, Msc

Role: CONTACT

Phone: 00329 332 22 96

Email: [email protected]

Facility Contacts

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Leen Maes, PhD

Role: primary

References

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Van Hecke R, Deconinck FJA, Wiersema JR, Clauws C, Danneels M, Dhooge I, Leyssens L, Van Waelvelde H, Maes L. Balanced Growth project: a protocol of a single-centre observational study on the involvement of the vestibular system in a child's motor and cognitive development. BMJ Open. 2021 Jun 11;11(6):e049165. doi: 10.1136/bmjopen-2021-049165.

Reference Type DERIVED
PMID: 34117049 (View on PubMed)

Other Identifiers

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B670201940165

Identifier Type: -

Identifier Source: org_study_id