跳至主要内容
临床试验/NCT05914207
NCT05914207尚未招募不适用

Effects of Lifestyle Modifications and Vestibular Rehabilitation Therapy in Children and Adolescents With Vestibular Migraine

University of Malaya2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Paediatric Dizziness Handicap Inventory

研究概览

简要总结

Vestibular dysfunction has traditionally been linked to various conditions that affect older adults. Recent studies have shown that children and adolescents suffer from vestibular impairments, yet the numbers are still low due to some factors, including the non-typical presentations. Vestibular migraine has been found to be the most common condition of vestibular dysfunction among children and adolescents. Nonetheless, most children remain undiagnosed due to lack awareness and vague clinical presentations. Parallel to that, there has been no consensus regarding the management algorithm. Most children are managed with pharmacological management extrapolated from the adult algorithm. Many clinicians fail to understand that pharmacological treatments are not sustainable long-term and should focus on lifestyle modifications such as sleep and dietary habits and other non-pharmacological treatments such as deep breathing exercises and vestibular rehabilitation therapy. This study aims to investigate the effect of non-pharmacological treatment in managing children and adolescents with VM. The investigators will use a standardised questionnaire before and after interventions to investigate the effect of lifestyle modifications, simple vestibular rehabilitation exercises and deep breathing techniques in children and adolescents with VM. Lifestyle modifications and vestibular rehabilitation exercise is a more sustainable way of managing children and adolescents with VM, avoiding the side effects of medication, and is more cost-effective. If the non-pharmacological treatment shows promising results, the investigators will continue with multicentre randomised-controlled studies.

详细描述

The prevalence of vestibular dysfunction is approximately 30.4% among children and adolescents. Yet, the exact prevalence in children remains a quandary owing to several factors: difficulties describing symptoms and cannot differentiate between true vertigo, unsteadiness, imbalance and light-headedness; secondly, the short-lived nature of some peripheral vestibular conditions results in early and rapid compensation; thirdly, nuanced clinical manifestations of vestibular as well as balance impairment accounts for it being overlooked finally, lack of specialists to manage children with vestibular impairment.

Vestibular dysfunction or impairment results in disturbance in the body's balance system. Nonetheless, the most common symptoms include vertigo, nausea, vomiting, intolerance to head motion, nystagmus, unsteady gait, and postural instability. Although clinical presentation may be mild, vestibular dysfunction may impact the quality of life and day-to-day activity, especially school activities such as reading and learning, which are vital for these age groups.

Vestibular loss affects cognitive and emotional disturbance related to reflexive deficits, which are related to the role of ascending vestibular pathway to the limbic system and the neocortex's role in the sense of spatial orientation. Vestibular and balance impairment amongst adolescents and young adults will, in the long term, affect social, emotional, psychological and quality of life as vestibular and balance function is imperative in day-to-day life and activity.

Vestibular migraine (VM) is found to be the most common cause of dizziness among children and adolescents. The exact prevalence of VM remains unknown as VM is still underdiagnosed due to a lack of awareness amongst parents and attending physicians. It is worth noting that the diagnosis of VM in children and adolescents has traditionally been based on the description of clinical symptoms by the patient or parents/caretaker. The lack of definitive biomarkers and gold-standard diagnostic tools contributes to the delay in diagnosis. The typical battery of investigations, including otological, neurological, ophthalmological, and imaging performed, are oftentimes carried out to rule out other pathological disorders.

Vestibular migraine in children is diagnosed based on diagnostic criteria which recently has been put forth by the Committee for the Classification of Vestibular Disorders of the Bar any Society (ICVD) and the Migraine Classification subgroup of the International Headache Society, which describes the three spectrums of VM: Vestibular Migraine of Childhood, probable Vestibular Migraine of Childhood and Recurrent Vertigo of Childhood specific for children under 18 years of age.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents between 5-18 years
  • Diagnosed with vestibular migraine based on the Diagnostic criteria consensus document of the Classification Committee of Vestibular Disorders of the Bárány Society and the International Headache Society

排除标准

  • Not able to comprehend or able to follow instructions
  • syndromic, other ontological, neurological conditions

结局指标

主要结局

Paediatric Dizziness Handicap Inventory

时间窗: This measure is carried after one month

This measure assesses impact of dizziness in children between 5-12 years

Dizziness Handicap Inventory

时间窗: This measure is carried out after one month

This measure assesses impact of dizziness in children above 12 -18

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeyasakthy Saniasiaya

Principal Investigator

University of Malaya

研究点 (2)

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