- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ruth Van Hecke, Msc
- Phone Number: 00329 332 22 96
- Email: ruth.vanhecke@ugent.be
Study Locations
-
-
-
Ghent, Belgium, 9000
- Recruiting
- Ghent University, department rehabilitation sciences
-
Contact:
- Leen Maes, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Typically developing school-aged children
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
|
Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks
|
Vestibular-impaired school-aged children
Study group to achieve objective 3 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments
|
Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks
|
Neurodevelopmental group (ADHD, ASD and/or DCD)
Study group to achieve objective 4 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments
|
Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.
|
video Head Impulse Test asymmetry (%)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.
|
Asymmetry of the vestibulo-ocular reflex between the left en right horizontal/anterior/posterior semicircular canals
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.
|
video Head Impulse Test presence of saccades (overt/covert)(n)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.
|
Absolute amount of corrective saccades during head impulse testing
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.
|
video Head Impulse Test presence of saccades (overt/covert)(% of the performed HITs)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.
|
Relative occurance of corrective saccades (with reference to the total amount of performed HITs) during head impulse testing
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.
|
Rotatory chair gain (%)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.
|
Gain of the vestibulo-ocular reflex (mid frequency function of the horizontal semicircular canals)
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.
|
Rotatory chair phase (°)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.
|
Phase lead between the eye and head velocity during rotatory chair testing
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.
|
Rotatory chair asymmetry (%)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.
|
Asymmetry of the vestibulo-ocular reflex between the left en right horizontal semicircular canal
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the Rotatory chair assessment (vestibular) which will take 10 minutes.
|
Slow component velocity (SCV; °/s) in the culmination phase of each irrigation
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.
|
The vestibulo-ocular reflex response (low frequency function of the horizontal semicircular canals)
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.
|
Sum of all irrigations (°/s)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.
|
The sum of the responses of the vestibulo-ocular reflex during the four irrigations
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.
|
Unilateral weakness (UW; %)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the caloric assessment (vestibular) which will take 15 minutes.
|
The asymmetry between the right and left horizontal semicircular canals (caloric testing)
|
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; %)
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)
|
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 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
|
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)
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
|
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 (%)
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
|
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 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
|
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)
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
|
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 (%)
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
|
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
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)
|
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
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
|
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
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
|
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)
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)
|
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
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
|
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)
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
|
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
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
|
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)
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
|
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)
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
|
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)
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
|
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 (%)
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
|
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)
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
|
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 (%)
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
|
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)
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
|
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 (%)
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
|
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)
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
|
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)
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
|
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)
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
|
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 (%)
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
|
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)
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
|
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 (%)
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
|
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)
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
|
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 (%)
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
|
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)
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
|
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)
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)
|
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)
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
|
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)
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
|
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)
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
|
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
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
|
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
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
|
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'
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
|
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)
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)
|
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)
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)
|
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)
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)
|
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)
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)
|
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)
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)
|
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)
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)
|
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)
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)
|
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)
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)
|
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)
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)
|
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 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)
|
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 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)
|
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 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)
|
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
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)
|
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)
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
|
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)
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the intelligence assessment which will take 20 minutes.
|
Static visual acuity
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.
|
The smallest optotype that can be correctly identified while the head is fixed
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.
|
Dynamic visual acuity
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.
|
The smallest optotype that can be correctly identified while moving the head
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.
|
The difference between static visual acuity and dynamic visual acuity
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.
|
This parameter results in the contribution of the vestibulo-ocular reflex during head movements
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.
|
Tympanometry: middle ear pressure (daPa)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.
|
Middle ear pressure of both ears
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.
|
Tympanometry: static acoustic admitance (mmho)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.
|
Static acoustic admitance (middle ear) of both ears
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.
|
Tympanometry: ear canal volume (cm³)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.
|
Ear canal volume of both ears
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (tympanometry) which will take 1 minutes.
|
OAE measurement: stimulus stability (%)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
Stimulus stability during OAE stimulation
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
OAE measurement: reproducibility (%)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
Reproducibility during OAE stimulation
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
OAE measurement: respone level (dB SPL)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
"Amplitude" of the OAE response
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
OAE measurement: noise level (dB SPL)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
"Amplitude" of the noise level
|
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
OAE measurement: signal to noise ratio (dB)
Time Frame: This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the hearing assessment (otoacoustic emissions) which will take 2 minutes.
|
"Amplitude" of the noise level vs "amplitude" of the OAE response
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leen Maes, PhD, Ghent University and Ghent University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B670201940165
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurodevelopmental Disorders
-
University of Missouri-ColumbiaCompletedChildren With Neurodevelopmental DisordersUnited States
-
IRCCS Eugenio MedeaRecruitingNeurodevelopmental Disorder (Diagnosis)Italy
-
NeuroModulation Technique Research InstituteCompletedAutism | Neurodevelopmental DisorderUnited States
-
University of StrathclydeGöteborg University; University of Aberdeen; University of Glasgow; HarimataUnknownAutism Spectrum Disorder | Other Neurodevelopmental DisorderSweden, United Kingdom
-
Iama Therapeutics S.r.l.Recruiting
-
University of AlbertaAlberta Health servicesRecruitingNeurodevelopmental DisordersCanada
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingNeurodevelopmental Disorders
-
University of North Carolina, Chapel HillNational Center for Advancing Translational Sciences (NCATS); RTI InternationalCompletedNeurodevelopmental DisordersUnited States
-
National Institute of Mental Health (NIMH)RecruitingHealthy Children | Children With Neurodevelopmental Disorders | Children With Neuropsychiatric Disorders | Children With Behavioral SyndromesUnited States
-
ProbiSearch SLNot yet recruitingNeurodevelopmental Disorders
Clinical Trials on Balanced Growth Protocol
-
VA Office of Research and DevelopmentRecruitingStroke | Balance DeficitsUnited States
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...UnknownCeliac DiseaseItaly
-
University of British ColumbiaBritish Columbia Cancer AgencyNot yet recruiting
-
University College, LondonUniversity College London HospitalsRecruitingObesity | Overweight | Cardiometabolic SyndromeUnited Kingdom
-
National Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting
-
NestléCompleted
-
National Taiwan University HospitalCompleted
-
roberta cazzolaIstituti Clinici di Perfezionamento di Milano; Luigi Sacco University HospitalCompletedMetabolic Syndrome | Obesity, Metabolically BenignItaly
-
B. Braun Melsungen AGTerminated
-
Mondelēz International, Inc.Centre de Recherche en Nutrition Humaine Rhone-Alpe; Biofortis Mérieux NutriSciencesCompleted