Vestibular DisorderNCT04685746
BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development
An observational study of Vestibular Disorder and Neurodevelopmental Disorders, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder, Neurodevelopmental Disorders
- What is being tested?
- Balanced Growth Protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jul 2019to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Typically developing children were used for establishing normative data of the protocol and to achieve objective 2 (convenience sampling; primary schools). Vestibular-impaired patients, established by extensive vestibular assessment for objective 3 (recruited at the Ghent University Hospital). The neurodevelopmental group was needed to establish objective 4 (recruited at schools for special education and/or care facilities).
Who may be able to join
- 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
- Diagnosed by a (neuro)psychiatric team with Autism Spectrum Disorder, Attention deficit/Hyperactivitiy Disorder and/or Developmental Coordination Disorder
Who cannot join
- Having a (permanent) hearing loss
- Having a (permanent) vestibular loss
- Having a motor dysfunction
- IQ < 70
- For vestibular-impaired children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University, department rehabilitation sciences
Ghent, 9000
Leen Maes, PhD
About this study
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.
Read the 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.
- Conditions
- Vestibular Disorder, Neurodevelopmental Disorders
- Being tested
- Balanced Growth Protocol
- Medical subject headings
- Vestibular Diseases, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced Growth ProtocolBehavioural
Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Balanced Growth Protocol | |
| Vestibular-impaired school-aged children | Study group to achieve objective 3 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments Receives: Behavioral: Balanced Growth Protocol | |
| 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 Receives: Behavioral: Balanced Growth Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
video Head Impulse Test gain (%)
Gain of the vestibulo-ocular reflex (high frequency function of the three semicircular canals)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the visuo-motor assessment which will take 20 minutes.
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start29 Jul 2019
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Leen Maes, PhD, Principal investigator, Ghent University and Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685746
- Sponsor's protocol ID
- B670201940165
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Hecke R, Deconinck FJA, Wiersema JR, Clauws C, Danneels M, Dhooge I, Leyssens L, Van Waelvelde H, Maes L. Balanced Growth project: a protocol of a single-centre observational study on the involvement of the vestibular system in a child's motor and cognitive development. BMJ Open. 2021 Jun 11;11(6):e049165. doi: 10.1136/bmjopen-2021-049165.
PubMed 34117049
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development
- ClinicalTrials.gov ID
- NCT04685746
- Acronym / sponsor ID
- B670201940165
- Conditions
- Vestibular Disorder, Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Typically developing school-aged children | – | Behavioral: Balanced Growth ProtocolStudy 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 | – | Behavioral: Balanced Growth ProtocolStudy group to achieve objective 3 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments |
| Neurodevelopmental group (ADHD, ASD and/or DCD) | – | Behavioral: Balanced Growth ProtocolStudy group to achieve objective 4 - Behavioural protocol: balanced growth protocol, consisting of audiovestibular, cognitive and motor assessments |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Typically developing children were used for establishing normative data of the protocol and to achieve objective 2 (convenience sampling; primary schools). Vestibular-impaired patients, established by extensive vestibular assessment for objective 3 (recruited at the Ghent University Hospital). The neurodevelopmental group was needed to establish objective 4 (recruited at schools for special education and/or care facilities).
Key inclusion criteria (4 listed)
- 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
- Diagnosed by a (neuro)psychiatric team with Autism Spectrum Disorder, Attention deficit/Hyperactivitiy Disorder and/or Developmental Coordination Disorder
Key exclusion criteria (5 listed)
- Having a (permanent) hearing loss
- Having a (permanent) vestibular loss
- Having a motor dysfunction
- IQ < 70
- For vestibular-impaired children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced Growth ProtocolAssessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks | Behavioural | Neurodevelopmental group (ADHD, ASD and/or DCD), Typically developing school-aged children, Vestibular-impaired school-aged children |
Primary outcome
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)
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
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
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
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)
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
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
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)
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
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)
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)
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
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
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
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
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
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
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)
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
12 secondary outcomes
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 34117049Van Hecke R, Deconinck FJA, Wiersema JR, Clauws C, Danneels M, Dhooge I, Leyssens L, Van Waelvelde H, Maes L. Balanced Growth project: a protocol of a single-centre observational study on the involvement of the vestibular system in a child's motor and cognitive development. BMJ Open. 2021 Jun 11;11(6):e049165. doi: 10.1136/bmjopen-2021-049165.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leen Maes, PhD principal investigator
Ghent University and Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Disorder and Neurodevelopmental Disorders, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Van Hecke, Msc (00329 332 22 96, ruth.vanhecke@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 63 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.