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Recruiting NCT04685746

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

Observational Vestibular Disorder Neurodevelopmental Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Balanced Growth Protocol.
Who it may be relevant to
Registry conditions: Vestibular Disorder, Neurodevelopmental Disorders. Basic parameters: 6 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

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

Primary outcome measures

  • video Head Impulse Test gain (%) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.]
  • video Head Impulse Test asymmetry (%) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.]
  • video Head Impulse Test presence of saccades (overt/covert)(n) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.]
  • video Head Impulse Test presence of saccades (overt/covert)(% of the performed HITs) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.]
  • Rotatory chair gain (%) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.]
  • Rotatory chair phase (°) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.]
  • Rotatory chair asymmetry (%) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.]
  • Slow component velocity (SCV; °/s) in the culmination phase of each irrigation [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.]
  • Sum of all irrigations (°/s) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.]
  • Unilateral weakness (UW; %) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.]
Secondary outcome measures (12)
  • Score of the short version (4 subtest form) (Aubry & Bourdin, 2018) of the Wechsler Intelligence Scale for Children-VNL; WISC-V-NL [Time frame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the intelligence assessment which will take 20 minutes.]
  • Static visual acuity [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.]
  • Dynamic visual acuity [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.]
  • The difference between static visual acuity and dynamic visual acuity [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.]
  • Tympanometry: middle ear pressure (daPa) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.]
  • Tympanometry: static acoustic admitance (mmho) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.]
  • Tympanometry: ear canal volume (cm³) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.]
  • OAE measurement: stimulus stability (%) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.]
  • OAE measurement: reproducibility (%) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.]
  • OAE measurement: respone level (dB SPL) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.]
  • OAE measurement: noise level (dB SPL) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.]
  • OAE measurement: signal to noise ratio (dB) [Time frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Belgium · 1 center
  • Ghent University, department rehabilitation sciences — Ghent

Publications

  • 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. PMID 34117049

Identifiers

NCT: NCT04685746 · B670201940165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗