BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development
- Conditions
- Vestibular DisorderNeurodevelopmental Disorders
- Interventions
- Behavioral: Balanced Growth Protocol
- Registration Number
- NCT04685746
- Lead Sponsor
- University Ghent
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Typically developing school-aged children Balanced Growth Protocol 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 Vestibular-impaired school-aged children Balanced Growth Protocol Study group to achieve objective 3 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments Neurodevelopmental group (ADHD, ASD and/or DCD) Balanced Growth Protocol Study group to achieve objective 4 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments
- Primary Outcome Measures
Name Time Method cVEMP: asymmetry ratio (%) 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
oVEMP: interpeak amplitude (µV) 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
video Head Impulse Test asymmetry (%) 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
video Head Impulse Test presence of saccades (overt/covert)(% of the performed HITs) 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
Unilateral weakness (UW; %) 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)
Directional preponderance (DP; %) 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)
cVEMP: rectified interpeak amplitude (µV) 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
oVEMP: asymmetry ratio (%) 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
video Head Impulse Test gain (%) 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)
Rotatory chair gain (%) 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)
oVEMP: the absolute latencies of N1 and P1 (ms) 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
Inhibition task: uncorrected errors naming (n) 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)
video Head Impulse Test presence of saccades (overt/covert)(n) 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
Rotatory chair phase (°) 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
Rotatory chair asymmetry (%) 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
cVEMP: the absolute latencies of P1 and N1 (ms) 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
Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): total score 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)
Slow component velocity (SCV; °/s) in the culmination phase of each irrigation 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)
Sum of all irrigations (°/s) 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
M CTSIB: the mean velocity (mm/s) of the oscillations of the COP 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
M CTSIB: and the velocity variance (mm²/s²) 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
Spatial span task: longest span (n) 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
Spatial span task: amount of correct trials (n) 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
Digit span task: longest span (n) 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
Digit span task: amount of correct digits (n) 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
Digit span task: amount of incorrect digits (%) 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
Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): subscale scores 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
Korpercoordination test fur kinder (KTK): raw scores (n) 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)
Digit span task: amount of incorrect digits (n) 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
Digit span task: number of correct trials (%) 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
Digit span task: response rate (ms) 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
Spatial span task: amount of correct squares (n) 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
Spatial span task: amount of incorrect squares (n) 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
Spatial span task: amount of incorrect squares (%) 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
Digit span task: number of correct trials (n) 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
Continuous performance task: β 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
Inhibition task: uncorrected errors switching (n) 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)
Inhitbition task: total amount of errors naming (n) 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)
Inhitbition task: time inhibition (s) 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)
Visual-Motor Integration (VMI) (Beery 6th edition): correct shapes (n) 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
Movement assessment battery for children, Dutch version, 2nd edition (M ABC II NL): item scores 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
M CTSIB: the surface (mm²) of the confidence ellipse 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
Spatial span task: amount of correct squares (%) 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
Spatial span task: amount of correct trials (%) 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
Spatial span task: response rate (ms) 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
Continuous performance task: total amount of errors (n) 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
Inhibition task: self-corrected errors naming (n) 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)
Inhibition task: self-corrected errors inhibition (n) 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)
M CTSIB: length covered by the consecutive center of pressure (COP) positions (mm) 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
Emotion recognition score (n) 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)
Continuous performance task: omissions (n) 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
Continuous performance task: commissions (n) 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
Continuous performance task: sustained attention 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
Continuous performance task: d' 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
Inhibition task: self-corrected errors switching (n) 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)
Inhibition task: uncorrected errors inhibition (n) 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)
Inhitbition task: total amount of errors inhibition (n) 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)
Digit span task: amount of correct digits (%) 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
Inhitbition task: time naming (s) 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)
Inhitbition task: total amount of errors switching (n) 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)
Inhitbition task: time switching (s) 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)
Questionnaire Behaviour Rating Inventory of Executive Function (BRIEF) scores 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)
Visual-Motor Integration (VMI) (Beery 6th edition): correct forms (n) 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
- Secondary Outcome Measures
Name Time Method Static visual acuity 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
Tympanometry: middle ear pressure (daPa) 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
Score of the short version (4 subtest form) (Aubry & Bourdin, 2018) of the Wechsler Intelligence Scale for Children-VNL; WISC-V-NL 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
OAE measurement: stimulus stability (%) 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
Dynamic visual acuity 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
Tympanometry: static acoustic admitance (mmho) 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
OAE measurement: reproducibility (%) 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
OAE measurement: noise level (dB SPL) 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
The difference between static visual acuity and dynamic visual acuity 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
OAE measurement: respone level (dB SPL) 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
Tympanometry: ear canal volume (cm³) 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
OAE measurement: signal to noise ratio (dB) 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
Trial Locations
- Locations (1)
Ghent University, department rehabilitation sciences
🇧🇪Ghent, Belgium