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

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685746
• Other study ID #: B670201940165
• Status: Recruiting
• Start date: July 29, 2019
• Est. completion date: October 31, 2028

Study information

• Verified date: November 2023
• Source: University Ghent
• Contact: Ruth Van Hecke, Msc
• Phone: 00329 332 22 96
• Email: ruth.vanhecke[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

General goals 1. Developing and standardizing a sensitive and specific test protocol for the detection of vestibular, cognitive and/or motor dysfunctions in school-aged children. 2. Investigate the relationship with and the involvement of the vestibular system in the motor and cognitive development of typically developing school-aged children. 3. Investigating whether a vestibular dysfunction (with/without an additional auditory disease) has an impact on motor and/or cognitive performances in school-aged children. 4. Investigating if in children with a known neurodevelopmental disorder an (additional) underlying vestibular dysfunction can be identified.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 31, 2028
• Est. primary completion date: October 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodevelopmental Disorders
• Vestibular Diseases
• Vestibular Disorder

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University, department rehabilitation sciences	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	video Head Impulse Test gain (%)	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.
Primary	video Head Impulse Test asymmetry (%)	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.
Primary	video Head Impulse Test presence of saccades (overt/covert)(n)	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.
Primary	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	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.
Primary	Rotatory chair gain (%)	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.
Primary	Rotatory chair phase (°)	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.
Primary	Rotatory chair asymmetry (%)	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.
Primary	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)	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.
Primary	Sum of all irrigations (°/s)	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.
Primary	Unilateral weakness (UW; %)	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.
Primary	Directional preponderance (DP; %)	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.
Primary	cVEMP: the absolute latencies of P1 and N1 (ms)	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.
Primary	cVEMP: rectified interpeak amplitude (µV)	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.
Primary	cVEMP: asymmetry ratio (%)	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.
Primary	oVEMP: the absolute latencies of N1 and P1 (ms)	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.
Primary	oVEMP: interpeak amplitude (µV)	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.
Primary	oVEMP: asymmetry ratio (%)	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.
Primary	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)	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.
Primary	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	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.
Primary	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	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.
Primary	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)	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.
Primary	M CTSIB: the surface (mm²) of the confidence ellipse	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.
Primary	M CTSIB: length covered by the consecutive center of pressure (COP) positions (mm)	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.
Primary	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	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.
Primary	M CTSIB: and the velocity variance (mm²/s²)	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.
Primary	Spatial span task: longest span (n)	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.
Primary	Spatial span task: amount of correct squares (n)	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.
Primary	Spatial span task: amount of correct squares (%)	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.
Primary	Spatial span task: amount of incorrect squares (n)	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.
Primary	Spatial span task: amount of incorrect squares (%)	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.
Primary	Spatial span task: amount of correct trials (n)	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.
Primary	Spatial span task: amount of correct trials (%)	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.
Primary	Spatial span task: response rate (ms)	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.
Primary	Digit span task: longest span (n)	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.
Primary	Digit span task: amount of correct digits (n)	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.
Primary	Digit span task: amount of correct digits (%)	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.
Primary	Digit span task: amount of incorrect digits (n)	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.
Primary	Digit span task: amount of incorrect digits (%)	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.
Primary	Digit span task: number of correct trials (n)	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.
Primary	Digit span task: number of correct trials (%)	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.
Primary	Digit span task: response rate (ms)	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.
Primary	Emotion recognition score (n)	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.
Primary	Continuous performance task: omissions (n)	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.
Primary	Continuous performance task: commissions (n)	"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.
Primary	Continuous performance task: total amount of errors (n)	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.
Primary	Continuous performance task: sustained attention	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.
Primary	Continuous performance task: ß	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.
Primary	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	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.
Primary	Inhibition task: self-corrected errors naming (n)	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.
Primary	Inhibition task: self-corrected errors inhibition (n)	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.
Primary	Inhibition task: self-corrected errors switching (n)	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.
Primary	Inhibition task: uncorrected errors naming (n)	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.
Primary	Inhibition task: uncorrected errors inhibition (n)	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.
Primary	Inhibition task: uncorrected errors switching (n)	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.
Primary	Inhitbition task: total amount of errors naming (n)	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.
Primary	Inhitbition task: total amount of errors inhibition (n)	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.
Primary	Inhitbition task: total amount of errors switching (n)	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.
Primary	Inhitbition task: time naming (s)	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.
Primary	Inhitbition task: time inhibition (s)	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.
Primary	Inhitbition task: time switching (s)	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.
Primary	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)	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.
Primary	Visual-Motor Integration (VMI) (Beery 6th edition): correct forms (n)	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.
Primary	Visual-Motor Integration (VMI) (Beery 6th edition): correct shapes (n)	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	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	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.
Secondary	Static visual acuity	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.
Secondary	Dynamic visual acuity	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.
Secondary	The difference between static visual acuity and dynamic visual acuity	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.
Secondary	Tympanometry: middle ear pressure (daPa)	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.
Secondary	Tympanometry: static acoustic admitance (mmho)	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.
Secondary	Tympanometry: ear canal volume (cm³)	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.
Secondary	OAE measurement: stimulus stability (%)	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.
Secondary	OAE measurement: reproducibility (%)	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.
Secondary	OAE measurement: respone level (dB SPL)	"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.
Secondary	OAE measurement: noise level (dB SPL)	"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.
Secondary	OAE measurement: signal to noise ratio (dB)	"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.