BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-13
SponsorUniversity Ghent
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Having a (permanent) hearing loss
Having a (permanent) vestibular loss
Having a motor dysfunction
IQ < 70
Trial 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).
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Balanced Growth Protocol
BehavioralAssessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: Typically developing school-aged children1 intervention
Group B: Vestibular-impaired school-aged children1 intervention
Group C: Neurodevelopmental group (ADHD, ASD and/or DCD)1 intervention
Trial outcomes
Primary outcomes
1
video Head Impulse Test gain (%)
Gain of the vestibulo-ocular reflex (high frequency function of the three semicircular canals)
Time frame
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.2
video Head Impulse Test asymmetry (%)
Asymmetry of the vestibulo-ocular reflex between the left en right horizontal/anterior/posterior semicircular canals
Time frame
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.3
video Head Impulse Test presence of saccades (overt/covert)(n)
Absolute amount of corrective saccades during head impulse testing
Time frame
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.4
video Head Impulse Test presence of saccades (overt/covert)(% of the performed HITs)
Relative occurance of corrective saccades (with reference to the total amount of performed HITs) during head impulse testing
Time frame
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is part of the vHIT assessment (vestibular) which will take 5 minutes.Secondary outcomes
1
Score of the short version (4 subtest form) (Aubry & Bourdin, 2018) of the Wechsler Intelligence Scale for Children-VNL; WISC-V-NL
Estimated intelligence score based on the subtests "matrix reasoning", "similarities", "vocabulary", and "block design"; with a higher score indicating a higher intelligence quotient
Time frame
This parameter will be assessed once during one of both testmoments (the cognitive appointment), and is an outcome parameter of the intelligence assessment which will take 20 minutes.2
Static visual acuity
The smallest optotype that can be correctly identified while the head is fixed
Time frame
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.3
Dynamic visual acuity
The smallest optotype that can be correctly identified while moving the head
Time frame
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.4
The difference between static visual acuity and dynamic visual acuity
This parameter results in the contribution of the vestibulo-ocular reflex during head movements
Time frame
This parameter will be assessed once during one of both testmoments (the motor/vestibular appointment), and is an outcome parameter of the ophtalmologic assessment which will take 5 minutes.Sponsors and contacts
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University Ghent
Lead sponsor
University Hospital, Ghent
Collaborator
Source ClinicalTrials.gov