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
- 30
- 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 prospective cohort study is to investigate the vestibular function in children suspected of balance disorders, and to follow up on their balance progressions after rehabilitation. The main hypothesis of the study is that delayed gross motor development and symptoms of dizziness and balance problems in some children are caused by vestibular dysfunction. The investigators expect that early detection and rehabilitation by a physiotherapist will improve the balance ability for the child. The participants will be children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/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.
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.
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
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: video Head Impulse Test (Diagnostic Test)
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.
干预措施: Cervical Vestibular Evoked Myogenic Potential (Diagnostic Test)
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.
干预措施: Ocular Vestibular Evoked Myogenic Potential (Diagnostic Test)
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.
干预措施: Computerized Dynamic Posturography (Diagnostic Test)
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.
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 and after 3 months of rehabilitation
Outcome measures: mean VOR gain
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
时间窗: Measured at baseline
Outcome measures: latency P1 and latency N1 in milliseconds (ms)
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
时间窗: Measured at baseline
Outcome measures: latency N1 and latency P1 in milliseconds
Computerized Dynamic Posturography (CDP)
时间窗: Measured at baseline and after 3 months of rehabilitation
Outcome measures: 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
- Vestibular dysfunction(Measured at baseline)
- Dizziness Handicap Inventory for patient caregivers (DHI-PC):(Measured at baseline and after 3 months of rehabilitation)
研究者
Signe Fiil Bønløkke
Principal Investigator
Gødstrup Hospital