An observational study in Vestibular Disorder and Neurodevelopmental Disorders, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by University Ghent · Observational
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.
General goals
172 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's planned enrollment of 250 is above the median of 59 across 34 observational studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
For typically developing children
Exclusion Criteria:
For vestibular-impaired children
Inclusion Criteria:
For neurodevelopmental group
Inclusion Criteria:
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
Behavioral: Balanced Growth Protocol
Study group to achieve objective 3 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments
Behavioral: Balanced Growth Protocol
Study group to achieve objective 4 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments
Behavioral: Balanced Growth Protocol
Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks
video Head Impulse Test gain (%)
Gain of the vestibulo-ocular reflex (high frequency function of the three semicircular canals)
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 (%)
Asymmetry of the vestibulo-ocular reflex between the left en right horizontal/anterior/posterior semicircular canals
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)
Absolute amount of corrective saccades during head impulse testing
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)
Relative occurance of corrective saccades (with reference to the total amount of performed HITs) during head impulse testing
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 (%)
Gain of the vestibulo-ocular reflex (mid frequency function of the horizontal semicircular canals)
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 (°)
Phase lead between the eye and head velocity during rotatory chair testing
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 (%)
Asymmetry of the vestibulo-ocular reflex between the left en right horizontal semicircular canal
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
The vestibulo-ocular reflex response (low frequency function of the horizontal semicircular canals)
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)
The sum of the responses of the vestibulo-ocular reflex during the four irrigations
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; %)
The asymmetry between the right and left horizontal semicircular canals (caloric testing)
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.
Directional preponderance (DP; %)
The asymmetry between nystagmus to the right vs to the left (caloric testing)
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.
cVEMP: the absolute latencies of P1 and N1 (ms)
Time between stimulation and onset of the response
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.
cVEMP: rectified interpeak amplitude (µV)
The amplitude of the cVEMP response
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.
cVEMP: asymmetry ratio (%)
The asymmetry between the right and left cVEMP response
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.
oVEMP: the absolute latencies of N1 and P1 (ms)
Time between stimulation and onset of the oVEMP response
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.
oVEMP: interpeak amplitude (µV)
The amplitude of the oVEMP response
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.
oVEMP: asymmetry ratio (%)
The asymmetry between the right and left oVEMP response
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.
Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): total score
Total motor competence score of the participant (33 - max. 104, with a higher score indicating a higher motor competence)
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.
Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): subscale scores
Subscale scores of the M ABC II NL test battery
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.
Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): item scores
Item scores of the M ABC II NL test battery
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.
Korpercoordination test fur kinder (KTK): raw scores (n)
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)
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.
M CTSIB: the surface (mm²) of the confidence ellipse
Confidence ellipse measured in millimeter² on force platform
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.
M CTSIB: length covered by the consecutive center of pressure (COP) positions (mm)
Length of the COP measured in millimeter on force platform
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.
M CTSIB: the mean velocity (mm/s) of the oscillations of the COP
Mean celocity of the oscillations of the COP measured on force platform
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.
M CTSIB: and the velocity variance (mm²/s²)
The oscillatory variance of the velocity of the COP measured on fore platform
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.
Spatial span task: longest span (n)
The maximum number of squares that the subject correctly touched during the task
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.
Spatial span task: amount of correct squares (n)
The absolute number of squares that the subject correctly touched during the task
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.
Spatial span task: amount of correct squares (%)
The relative number of squares that the subject correctly touched during the task
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.
Spatial span task: amount of incorrect squares (n)
The absolute number of incorrect squares that the subject touched during the task
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.
Spatial span task: amount of incorrect squares (%)
The relative number of incorrect squares that the subject touched during the task
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.
Spatial span task: amount of correct trials (n)
The absolute number of correct trials completed by the subject
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.
Spatial span task: amount of correct trials (%)
The relative number of correct trials completed by the subject
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.
Spatial span task: response rate (ms)
The response rate during each trial
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.
Digit span task: longest span (n)
The maximum number of digits that the subject correctly recalled during the task
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.
Digit span task: amount of correct digits (n)
cfr. spatial span
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.
Digit span task: amount of correct digits (%)
cfr. spatial span
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.
Digit span task: amount of incorrect digits (n)
cfr. spatial span
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.
Digit span task: amount of incorrect digits (%)
cfr. spatial span
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.
Digit span task: number of correct trials (n)
cfr. spatial span
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.
Digit span task: number of correct trials (%)
cfr. spatial span
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.
Digit span task: response rate (ms)
cfr. spatial span
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.
Emotion recognition score (n)
Amount of correct recognized emotions per condition (NEPSY II NL)
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.
Continuous performance task: omissions (n)
Amount of fails to press the button after the target appears
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.
Continuous performance task: commissions (n)
"false alarm", when a participant presses the button for a non-target
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.
Continuous performance task: total amount of errors (n)
Outcome 36 + 37
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.
Continuous performance task: sustained attention
Measured by calculating the change in hit and false alarm rates throughout the task
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.
Continuous performance task: β
Measure of impulsivity
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.
Continuous performance task: d'
Measure of visual selective attention; the probability of a hit vs a false alarm, taking into account the possibility of chance responding
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.
Inhibition task: self-corrected errors naming (n)
Total amount of self-corrected errors during the condition "Naming" (NEPSY II NL)
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.
Inhibition task: self-corrected errors inhibition (n)
Total amount of self-corrected errors during the condition "Inhibition" (NEPSY II NL)
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.
Inhibition task: self-corrected errors switching (n)
Total amount of self-corrected errors during the condition "Switching" (NEPSY II NL)
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.
Inhibition task: uncorrected errors naming (n)
Total amount of uncorrected errors during the condition "Naming" (NEPSY II NL)
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.
Inhibition task: uncorrected errors inhibition (n)
Total amount of uncorrected errors during the condition "Inhibition" (NEPSY II NL)
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.
Inhibition task: uncorrected errors switching (n)
Total amount of uncorrected errors during the condition "Switching" (NEPSY II NL)
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.
Inhitbition task: total amount of errors naming (n)
Total amount of errors during the condition "Naming" (NEPSY II NL)
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.
Inhitbition task: total amount of errors inhibition (n)
Total amount of errors during the condition "Inhibition" (NEPSY II NL)
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.
Inhitbition task: total amount of errors switching (n)
Total amount of errors during the condition "Switching" (NEPSY II NL)
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.
Inhitbition task: time naming (s)
Time needed to complete the condition "Naming" (NEPSY II NL)
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.
Inhitbition task: time inhibition (s)
Time needed to complete the condition "Inhibition" (NEPSY II NL)
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.
Inhitbition task: time switching (s)
Time needed to complete the condition "Switching" (NEPSY II NL)
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.
Questionnaire Behaviour Rating Inventory of Executive Function (BRIEF) scores
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)
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.
Visual-Motor Integration (VMI) (Beery 6th edition): correct forms (n)
Total number of correct identified forms
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.
Visual-Motor Integration (VMI) (Beery 6th edition): correct shapes (n)
Total number of correctly completed shapes
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.
Score of the short version (4 subtest form) (Aubry & Bourdin, 2018) of the Wechsler Intelligence Scale for Children-VNL; WISC-V-NL
Estimated intelligence score based on the subtests "matrix reasoning", "similarities", "vocabulary", and "block design"; with a higher score indicating a higher intelligence quotient
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
The smallest optotype that can be correctly identified while the head is fixed
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
The smallest optotype that can be correctly identified while moving the head
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
This parameter results in the contribution of the vestibulo-ocular reflex during head movements
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)
Middle ear pressure of both ears
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)
Static acoustic admitance (middle ear) of both ears
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)
Ear canal volume of both ears
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 (%)
Stimulus stability during OAE stimulation
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 (%)
Reproducibility during OAE stimulation
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)
"Amplitude" of the OAE response
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)
"Amplitude" of the noise level
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)
"Amplitude" of the noise level vs "amplitude" of the OAE response
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.
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