Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- video Head Impulse Test (vHIT)
研究概览
简要总结
The goal of this age-based cohort study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics. The participants will be children in the age of 6 months to 10 years, without any known hearing or balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.
详细描述
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.
Knowledge about the prevalence of vestibular impairment and normative data of vestibular function in the Danish pediatric population is missing.
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 provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics.
Methods: The study is an age-based cohort study. Participants are children in the age of 6 months to 10 years, without any known hearing or balance problems. The participants are recruited in local nurseries, kinder gardens, and schools. All participants will go through a test protocol consisting of questionnaires, hearing screening and vestibular and postural assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in the age of 6 months -10 years
- •Normal hearing
- •No history of dizziness or balance problems
- •Written informed consent from the parents.
排除标准
- •Premature birth
- •Existing or previous inner ear disease(s) or previous inner ear surgery
- •Cholesteatoma or previous middle ear surgery
- •Known or previous vestibular disorder (Vestibular schwannoma, Mb Meniere, vestibular neuritis or other known)
- •Delayed gross motor development evaluated through milestones.
- •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
- •A diagnose of any neurological disease.
- •A diagnose of any psychiatric disease.
- •VEMP-electrode allergy
- •History of symptomatic head or neck trauma
- •Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)
研究组 & 干预措施
Healthy children without hearing or balance problems
Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.
干预措施: video Head Impulse Test (Diagnostic Test)
Healthy children without hearing or balance problems
Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.
干预措施: Cervical Vestibular Evoked Myogenic Potential (Diagnostic Test)
Healthy children without hearing or balance problems
Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.
干预措施: Ocular Vestibular Evoked Myogenic Potential (Diagnostic Test)
Healthy children without hearing or balance problems
Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.
干预措施: Computerized Dynamic Posturography (Diagnostic Test)
Healthy children without hearing or balance problems
Healthy children in the age of 6 months to 10 years, without any known hearing or balance problems and with normal gross motor development are recruited in local nurseries, kinder gardens, and schools.
干预措施: Dizziness Handicap Inventory for patient caregivers (Other)
结局指标
主要结局
video Head Impulse Test (vHIT)
时间窗: Measured at baseline.
Outcome measures: Age-based norms for mean VOR gain
Cervical Vestibular Evoked Myogenic Potential (cVEMP):
时间窗: Measured at baseline.
Outcome measures: Age-based norms for latency P1 and latency N1 in milliseconds (ms)
Ocular Vestibular Evoked Myogenic Potential (oVEMP):
时间窗: Measured at baseline.
Outcome measures: Age-based norms for latency N1 and latency P1 in milliseconds
Computerized Dynamic Posturography (CDP)
时间窗: Measured at baseline.
Outcome measures: Aged-based norms for Sensory Organization Test (SOT): * Average equilibrium score (ES) for SOT1-6. Equilibrium scores is the average of three trials for each of the six conditions SOT1-6. * The SOT Composite score. It is a weighted average of the six conditions (SOT1-6) with greater weight given to the more difficult conditions. * The preference score. The preference score = (SOT3 + SOT6) / (SOT2 + SOT5)).
次要结局
- Dizziness Handicap Inventory for patient caregivers (DHI-PC):(Measured at baseline.)
- Success rate of the vestibular test protocol(Measured at baseline)
研究者
Signe Fiil Bønløkke
Principal Investigator
Gødstrup Hospital