- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06229704
Vestibular and Postural Function in Children Suspected of Balance Disorders (VASIC)
Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
Study Overview
Status
Intervention / Treatment
Detailed Description
Balance problems in children are an overlooked issue in the Danish healthcare system. Dysfunction of the vestibular system, i.e. vestibular dysfunction (VD), can have significant consequences for children's development and quality of life.
Several studies have shown that VD in infants may cause delayed gross motor development and milestones, such as head stabilization, sitting, and walking. Moreover, VD is found to have a negative impact on fine motor skills, reading, writing, and learning ability. Early diagnostics is important to reduce this latency and the negative impact on quality of life.
The investigators aim for a child friendly and reliable vestibular test protocol in the study. According to the investigators studies as well as international reports, the investigators have chosen a vestibular test protocol with Video Head Impulse Test (v-HIT), cervical and ocular Vestibular Evoked Myogenic Potential (c and oVEMP) as the tests are feasible, valid, and child friendly. To evaluate overall balance ability, the children are tested on a Computerized Dynamic Posturography.
The aim of the study is to investigate the vestibular function in children suspected of balance disorders, and to follow up on their balance progressions after rehabilitation.
Hypothesis: The investigators expect that delayed gross motor development and symptoms of dizziness and balance problems in some children are caused by VD. The investigators expect that early detection and rehabilitation by a physiotherapist will improve the balance ability for the child.
Methods: The study is a prospective cohort study, with follow up after rehabilitation. Participants are children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/balance problems. The participants are recruited at The Pediatric Department at Gødstrup Hospital, Denmark. The investigators intend to include all consecutive children referred to the Department within one year. All participants will go through a test protocol consisting of questionnaires, hearing screening and vestibular and postural assessments.
The primary endpoints are results of v-HIT, c and oVEMP, and posturography, which are compared to normative values. The secondary endpoints are prevalence of vestibular dysfunction and chance in vestibular and postural test results after three months of rehabilitation and mean total Dizziness Handicap Inventory for patient caregivers (DHI-PC) score. A number of variables are collected such as demographics, developmental milestones, family history with focus on hearing and balance.
Data are collected at baseline and after three months of rehabilitation.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Signe F Bønløkke, PhD student
- Phone Number: +45 41405064
- Email: siband@rm.dk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children in the age of 6 months to 10 years
- Delayed gross motor development and/or dizziness/balance problems.
- Written informed consent from the parents.
Exclusion Criteria:
- Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.
- Congenital nystagmus
- Compromised eye muscle mobility
- VEMP-electrode allergy
- History of symptomatic head or neck trauma
- Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with delayed gross motor development and/or with dizziness/balance problems
Children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/balance problems are recruited at The Pediatric Department at Gødstrup Hospital, Denmark.
|
For v-HIT, the Synapsys v-HIT Ulmer device is used.
Other Names:
For cVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used.
To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated.
The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility.
500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.
Other Names:
For oVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used.
To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated.
The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility.
500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate.
Other Names:
To evaluate functional balance of the children and the relative contributions of the vision, proprioception, and vestibular system a CDP from Virtualis (Virtualis, Montpellier, France) is used.
Other Names:
DHI is a caregiver-reported 21- item questionnaire.
It is designed to evaluate the perceived quality of life and handicap resulting from dizziness and unsteadiness for the pediatric population.
For each question there are three possible answers: yes, sometimes or no.
Each answer provides respectively 4, 2 and 0 points.
The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap.
Scores under 16 are characterized as no limitation or handicap.
A score from 16-26 present a mild perceived handicap and mild limitations.
A DHI-score between 26-43 is classified as a moderate problem, and a score above 43 describes a severe perceived handicap and severe limitations.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
video Head Impulse Test (vHIT)
Time Frame: Measured at baseline and after 3 months of rehabilitation
|
Outcome measures: mean VOR gain
|
Measured at baseline and after 3 months of rehabilitation
|
video Head Impulse Test (vHIT)
Time Frame: Measured at baseline and after 3 months of rehabilitation
|
Outcome measures: VOR gain asymmetry in percent (%)
|
Measured at baseline and after 3 months of rehabilitation
|
video Head Impulse Test (vHIT)
Time Frame: Measured at baseline and after 3 months of rehabilitation
|
Outcome measures: description of saccades (overt and covert saccades)
|
Measured at baseline and after 3 months of rehabilitation
|
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Time Frame: Measured at baseline
|
Outcome measures: latency P1 and latency N1 in milliseconds (ms)
|
Measured at baseline
|
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Time Frame: Measured at baseline
|
Outcome measures: rectified interpeak amplitude P1-N1
|
Measured at baseline
|
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Time Frame: Measured at baseline
|
Outcome measures: averaged EMG in μV
|
Measured at baseline
|
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Time Frame: Measured at baseline
|
Outcome measures: left-right asymmetry ratio in percent (%)
|
Measured at baseline
|
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Time Frame: Measured at baseline
|
Outcome measures: latency N1 and latency P1 in milliseconds
|
Measured at baseline
|
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Time Frame: Measured at baseline
|
Outcome measures: interpeak amplitude N1-P1 in μV
|
Measured at baseline
|
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Time Frame: Measured at baseline
|
Outcome measures: left-right asymmetry ratio in percent (%)
|
Measured at baseline
|
Computerized Dynamic Posturography (CDP)
Time Frame: Measured at baseline and after 3 months of rehabilitation
|
Outcome measures: Sensory Organization Test (SOT):
|
Measured at baseline and after 3 months of rehabilitation
|
Computerized Dynamic Posturography (CDP)
Time Frame: Measured at baseline and after 3 months of rehabilitation
|
Outcome measures: Motor Control Test (MCT): • Mean latency of the medium and the big movement respectively in anterior and posterior direction measured in milliseconds. |
Measured at baseline and after 3 months of rehabilitation
|
Computerized Dynamic Posturography (CDP)
Time Frame: Measured at baseline and after 3 months of rehabilitation
|
Outcome measures: for ADaptation Test (ADT): • Mean sway energy score of toes-up and toes-down respectively. The sway energy score quantifies the force magnitude required to overcome the postural instability. |
Measured at baseline and after 3 months of rehabilitation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vestibular dysfunction
Time Frame: Measured at baseline
|
Prevalence of vestibular dysfunction
|
Measured at baseline
|
Dizziness Handicap Inventory for patient caregivers (DHI-PC):
Time Frame: Measured at baseline and after 3 months of rehabilitation
|
Outcome measures: Mean total DHI-PC score.
DHI-PC is a caregiver-reported 21-item questionnaire.
For each question there are three possible answers: yes, sometimes or no.
Each answer provides respectively 4, 2 and 0 points.
The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap.
|
Measured at baseline and after 3 months of rehabilitation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Therese Ovesen, Professor, University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFB-4-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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