Clinical trial NCT04685746: BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development
Official title: BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vestibular Disorder
Neurodevelopmental Disorders
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2020-12-28
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Typically developing children were used for establishing normative data of the protocol and to achieve objective 2 (convenience sampling; primary schools). Vestibular-impaired patients, established by extensive vestibular assessment for objective 3 (recruited at the Ghent University Hospital). The neurodevelopmental group was needed to establish objective 4 (recruited at schools for special education and/or care facilities).

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.

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.

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

Primary outcomes:
measure: video Head Impulse Test gain (%)
timeFrame: 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.
measure: video Head Impulse Test asymmetry (%)
timeFrame: 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.
measure: video Head Impulse Test presence of saccades (overt/covert)(n)
timeFrame: 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.
measure: video Head Impulse Test presence of saccades (overt/covert)(% of the performed HITs)
timeFrame: 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.
measure: Rotatory chair gain (%)
timeFrame: 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.
measure: Rotatory chair phase (°)
timeFrame: 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.
measure: Rotatory chair asymmetry (%)
timeFrame: 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.
measure: Slow component velocity (SCV; °/s) in the culmination phase of each irrigation
timeFrame: 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.
measure: Sum of all irrigations (°/s)
timeFrame: 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.
measure: Unilateral weakness (UW; %)
timeFrame: 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.
measure: Directional preponderance (DP; %)
timeFrame: 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.
measure: cVEMP: the absolute latencies of P1 and N1 (ms)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the cVEMP assessment (vestibular) which will take 5 minutes.
measure: cVEMP: rectified interpeak amplitude (µV)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the cVEMP assessment (vestibular) which will take 5 minutes.
measure: cVEMP: asymmetry ratio (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the cVEMP assessment (vestibular) which will take 5 minutes.
measure: oVEMP: the absolute latencies of N1 and P1 (ms)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the oVEMP assessment (vestibular) which will take 5 minutes.
measure: oVEMP: interpeak amplitude (µV)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the oVEMP assessment (vestibular) which will take 5 minutes.
measure: oVEMP: asymmetry ratio (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the oVEMP assessment (vestibular) which will take 5 minutes.
measure: Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): total score
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the M ABC II NL assessment (motor) which will take 20 minutes.
measure: Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): subscale scores
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the M ABC II NL assessment (motor) which will take 20 minutes.
measure: Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): item scores
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the M ABC II NL assessment (motor) which will take 20 minutes.
measure: Korpercoordination test fur kinder (KTK): raw scores (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the KTK assessment (motor) which will take 5 minutes.
measure: M CTSIB: the surface (mm²) of the confidence ellipse
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the M CTSIB assessment (motor) which will take 5 minutes.
measure: M CTSIB: length covered by the consecutive center of pressure (COP) positions (mm)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the M CTSIB assessment (motor) which will take 5 minutes.
measure: M CTSIB: the mean velocity (mm/s) of the oscillations of the COP
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the M CTSIB assessment (motor) which will take 5 minutes.
measure: M CTSIB: and the velocity variance (mm²/s²)
timeFrame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the M CTSIB assessment (motor) which will take 5 minutes.
measure: Spatial span task: longest span (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Spatial span task: amount of correct squares (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Spatial span task: amount of correct squares (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Spatial span task: amount of incorrect squares (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Spatial span task: amount of incorrect squares (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Spatial span task: amount of correct trials (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Spatial span task: amount of correct trials (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Spatial span task: response rate (ms)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the spatial span assessment which will take 5 minutes.
measure: Digit span task: longest span (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Digit span task: amount of correct digits (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Digit span task: amount of correct digits (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Digit span task: amount of incorrect digits (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Digit span task: amount of incorrect digits (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Digit span task: number of correct trials (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Digit span task: number of correct trials (%)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Digit span task: response rate (ms)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the digit span assessment which will take 5 minutes.
measure: Emotion recognition score (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the emotion recognition assessment which will take 5 minutes.
measure: Continuous performance task: omissions (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the attention assessment which will take 10 minutes.
measure: Continuous performance task: commissions (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the attention assessment which will take 10 minutes.
measure: Continuous performance task: total amount of errors (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the attention assessment which will take 10 minutes.
measure: Continuous performance task: sustained attention
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the attention assessment which will take 10 minutes.
measure: Continuous performance task: β
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the attention assessment which will take 10 minutes.
measure: Continuous performance task: d'
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the attention assessment which will take 10 minutes.
measure: Inhibition task: self-corrected errors naming (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhibition task: self-corrected errors inhibition (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhibition task: self-corrected errors switching (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhibition task: uncorrected errors naming (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhibition task: uncorrected errors inhibition (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhibition task: uncorrected errors switching (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhitbition task: total amount of errors naming (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhitbition task: total amount of errors inhibition (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhitbition task: total amount of errors switching (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhitbition task: time naming (s)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhitbition task: time inhibition (s)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Inhitbition task: time switching (s)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the inhibition assessment which will take 10 minutes.
measure: Questionnaire Behaviour Rating Inventory of Executive Function (BRIEF) scores
timeFrame: This parameter will be assessed once during one of both testmoments (questionnaire for the parents), and is an outcome parameter of the executive function assessment which will take 10 minutes.
measure: Visual-Motor Integration (VMI) (Beery 6th edition): correct forms (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the visuo-motor assessment which will take 20 minutes.
measure: Visual-Motor Integration (VMI) (Beery 6th edition): correct shapes (n)
timeFrame: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the visuo-motor assessment which will take 20 minutes.
Secondary outcomes:
measure: Score of the short version (4 subtest form) (Aubry & Bourdin, 2018) of the Wechsler Intelligence Scale for Children-VNL; WISC-V-NL
timeFrame: 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.
measure: Static visual acuity
timeFrame: 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.
measure: Dynamic visual acuity
timeFrame: 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.
measure: The difference between static visual acuity and dynamic visual acuity
timeFrame: 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.
measure: Tympanometry: middle ear pressure (daPa)
timeFrame: 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.
measure: Tympanometry: static acoustic admitance (mmho)
timeFrame: 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.
measure: Tympanometry: ear canal volume (cm³)
timeFrame: 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.
measure: OAE measurement: stimulus stability (%)
timeFrame: 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.
measure: OAE measurement: reproducibility (%)
timeFrame: 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.
measure: OAE measurement: respone level (dB SPL)
timeFrame: 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.
measure: OAE measurement: noise level (dB SPL)
timeFrame: 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.
measure: OAE measurement: signal to noise ratio (dB)
timeFrame: 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.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University, department rehabilitation sciences
Study officials:
affiliation: Ghent University and Ghent University Hospital
name: Leen Maes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.