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NCT Number: NCT04685746

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

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.

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Key information

Conditions

Vestibular Disorder Ear Diseases Labyrinth Diseases Mental Disorders Neurodevelopmental Disorders Otorhinolaryngologic Diseases Vestibular Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University, department rehabilitation sciences

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Leen Maes, PhD

CONTACT

About this study

General goals

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balanced Growth Protocol

Behavioral

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

Primary outcomes

  1. 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.

    Gain of the vestibulo-ocular reflex (high frequency function of the three semicircular canals)

  2. 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.

    Asymmetry of the vestibulo-ocular reflex between the left en right horizontal/anterior/posterior semicircular canals

  3. 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.

    Absolute amount of corrective saccades during head impulse testing

  4. 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.

    Relative occurance of corrective saccades (with reference to the total amount of performed HITs) during head impulse testing

  5. 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.

    Gain of the vestibulo-ocular reflex (mid frequency function of the horizontal semicircular canals)

  6. 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.

    Phase lead between the eye and head velocity during rotatory chair testing

  7. 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.

    Asymmetry of the vestibulo-ocular reflex between the left en right horizontal semicircular canal

  8. 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.

    The vestibulo-ocular reflex response (low frequency function of the horizontal semicircular canals)

  9. 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.

    The sum of the responses of the vestibulo-ocular reflex during the four irrigations

  10. 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.

    The asymmetry between the right and left horizontal semicircular canals (caloric testing)

  11. Directional preponderance (DP; %)

    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.

    The asymmetry between nystagmus to the right vs to the left (caloric testing)

  12. cVEMP: the absolute latencies of P1 and N1 (ms)

    Time frame: 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.

    Time between stimulation and onset of the response

  13. cVEMP: rectified interpeak amplitude (µV)

    Time frame: 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.

    The amplitude of the cVEMP response

  14. cVEMP: asymmetry ratio (%)

    Time frame: 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.

    The asymmetry between the right and left cVEMP response

  15. oVEMP: the absolute latencies of N1 and P1 (ms)

    Time frame: 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.

    Time between stimulation and onset of the oVEMP response

  16. oVEMP: interpeak amplitude (µV)

    Time frame: 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.

    The amplitude of the oVEMP response

  17. oVEMP: asymmetry ratio (%)

    Time frame: 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.

    The asymmetry between the right and left oVEMP response

  18. Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): total score

    Time frame: 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.

    Total motor competence score of the participant (33 - max. 104, with a higher score indicating a higher motor competence)

  19. Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): subscale scores

    Time frame: 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.

    Subscale scores of the M ABC II NL test battery

  20. Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): item scores

    Time frame: 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.

    Item scores of the M ABC II NL test battery

  21. Korpercoordination test fur kinder (KTK): raw scores (n)

    Time frame: 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.

    Amount of steps during the first subtest of the KTK (backward beam walking) (min. 0 - max. 72, with higher scores indicating better postural control during a dynamic balance task)

  22. M CTSIB: the surface (mm²) of the confidence ellipse

    Time frame: 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.

    Confidence ellipse measured in millimeter² on force platform

  23. M CTSIB: length covered by the consecutive center of pressure (COP) positions (mm)

    Time frame: 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.

    Length of the COP measured in millimeter on force platform

  24. M CTSIB: the mean velocity (mm/s) of the oscillations of the COP

    Time frame: 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.

    Mean celocity of the oscillations of the COP measured on force platform

  25. M CTSIB: and the velocity variance (mm²/s²)

    Time frame: 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.

    The oscillatory variance of the velocity of the COP measured on fore platform

  26. Spatial span task: longest span (n)

    Time frame: 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.

    The maximum number of squares that the subject correctly touched during the task

  27. Spatial span task: amount of correct squares (n)

    Time frame: 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.

    The absolute number of squares that the subject correctly touched during the task

  28. Spatial span task: amount of correct squares (%)

    Time frame: 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.

    The relative number of squares that the subject correctly touched during the task

  29. Spatial span task: amount of incorrect squares (n)

    Time frame: 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.

    The absolute number of incorrect squares that the subject touched during the task

  30. Spatial span task: amount of incorrect squares (%)

    Time frame: 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.

    The relative number of incorrect squares that the subject touched during the task

  31. Spatial span task: amount of correct trials (n)

    Time frame: 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.

    The absolute number of correct trials completed by the subject

  32. Spatial span task: amount of correct trials (%)

    Time frame: 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.

    The relative number of correct trials completed by the subject

  33. Spatial span task: response rate (ms)

    Time frame: 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.

    The response rate during each trial

  34. Digit span task: longest span (n)

    Time frame: 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.

    The maximum number of digits that the subject correctly recalled during the task

  35. Digit span task: amount of correct digits (n)

    Time frame: 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.

    cfr. spatial span

  36. Digit span task: amount of correct digits (%)

    Time frame: 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.

    cfr. spatial span

  37. Digit span task: amount of incorrect digits (n)

    Time frame: 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.

    cfr. spatial span

  38. Digit span task: amount of incorrect digits (%)

    Time frame: 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.

    cfr. spatial span

  39. Digit span task: number of correct trials (n)

    Time frame: 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.

    cfr. spatial span

  40. Digit span task: number of correct trials (%)

    Time frame: 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.

    cfr. spatial span

  41. Digit span task: response rate (ms)

    Time frame: 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.

    cfr. spatial span

  42. Emotion recognition score (n)

    Time frame: 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.

    Amount of correct recognized emotions per condition (NEPSY II NL)

  43. Continuous performance task: omissions (n)

    Time frame: 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.

    Amount of fails to press the button after the target appears

  44. Continuous performance task: commissions (n)

    Time frame: 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.

    "false alarm", when a participant presses the button for a non-target

  45. Continuous performance task: total amount of errors (n)

    Time frame: 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.

    Outcome 36 + 37

  46. Continuous performance task: sustained attention

    Time frame: 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.

    Measured by calculating the change in hit and false alarm rates throughout the task

  47. Continuous performance task: β

    Time frame: 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 of impulsivity

  48. Continuous performance task: d'

    Time frame: 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 of visual selective attention; the probability of a hit vs a false alarm, taking into account the possibility of chance responding

  49. Inhibition task: self-corrected errors naming (n)

    Time frame: 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.

    Total amount of self-corrected errors during the condition "Naming" (NEPSY II NL)

  50. Inhibition task: self-corrected errors inhibition (n)

    Time frame: 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.

    Total amount of self-corrected errors during the condition "Inhibition" (NEPSY II NL)

  51. Inhibition task: self-corrected errors switching (n)

    Time frame: 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.

    Total amount of self-corrected errors during the condition "Switching" (NEPSY II NL)

  52. Inhibition task: uncorrected errors naming (n)

    Time frame: 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.

    Total amount of uncorrected errors during the condition "Naming" (NEPSY II NL)

  53. Inhibition task: uncorrected errors inhibition (n)

    Time frame: 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.

    Total amount of uncorrected errors during the condition "Inhibition" (NEPSY II NL)

  54. Inhibition task: uncorrected errors switching (n)

    Time frame: 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.

    Total amount of uncorrected errors during the condition "Switching" (NEPSY II NL)

  55. Inhitbition task: total amount of errors naming (n)

    Time frame: 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.

    Total amount of errors during the condition "Naming" (NEPSY II NL)

  56. Inhitbition task: total amount of errors inhibition (n)

    Time frame: 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.

    Total amount of errors during the condition "Inhibition" (NEPSY II NL)

  57. Inhitbition task: total amount of errors switching (n)

    Time frame: 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.

    Total amount of errors during the condition "Switching" (NEPSY II NL)

  58. Inhitbition task: time naming (s)

    Time frame: 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.

    Time needed to complete the condition "Naming" (NEPSY II NL)

  59. Inhitbition task: time inhibition (s)

    Time frame: 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.

    Time needed to complete the condition "Inhibition" (NEPSY II NL)

  60. Inhitbition task: time switching (s)

    Time frame: 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.

    Time needed to complete the condition "Switching" (NEPSY II NL)

  61. Questionnaire Behaviour Rating Inventory of Executive Function (BRIEF) scores

    Time frame: 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.

    The overall score and the subscores (n) of this validated questionnaire consisting of 75 items (3-point Likert scale) (min. 72 - max. 216, with higher scores indicating a higher level of executive functions)

  62. Visual-Motor Integration (VMI) (Beery 6th edition): correct forms (n)

    Time frame: 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.

    Total number of correct identified forms

  63. Visual-Motor Integration (VMI) (Beery 6th edition): correct shapes (n)

    Time frame: 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.

    Total number of correctly completed shapes

Secondary outcomes

  1. 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.

    Estimated intelligence score based on the subtests "matrix reasoning", "similarities", "vocabulary", and "block design"; with a higher score indicating a higher intelligence quotient

  2. 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.

    The smallest optotype that can be correctly identified while the head is fixed

  3. 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 smallest optotype that can be correctly identified while moving the head

  4. 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.

    This parameter results in the contribution of the vestibulo-ocular reflex during head movements

  5. 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.

    Middle ear pressure of both ears

  6. 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.

    Static acoustic admitance (middle ear) of both ears

  7. 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.

    Ear canal volume of both ears

  8. 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.

    Stimulus stability during OAE stimulation

  9. 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.

    Reproducibility during OAE stimulation

  10. 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.

    "Amplitude" of the OAE response

  11. 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.

    "Amplitude" of the noise level

  12. 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.

    "Amplitude" of the noise level vs "amplitude" of the OAE response

Study contacts

Contact information is provided by the study sponsor or research team.

Ruth Van Hecke, Msc

CONTACT

[email protected]

00329 332 22 96

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • University Hospital, Ghent

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Dec 28, 2020
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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