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临床试验/NCT03417596
NCT03417596已完成不适用

Efficacy of Vestibular Rehabilitation in Patients With Vestibular Migraine

Ege University0 个研究点目标入组 77 人开始时间: 2015年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
77
主要终点
Dizziness Handicap Inventory

研究概览

简要总结

Abstract: Introduction:

Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. VM can make a huge impact on quality of life, therefore advances in its diagnosis and management are valuable. While pharmacotherapy that is being used in migraine can be beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most important types of treatment in management of VM. This study compares the results of pharmacological management options and vestibular rehabilitation programmes in the context of dizziness, balance problems and headache.

Material and methods:

77 patients with VM were included in study, and 60 of them completed it. While one group took only VR programme, and another took only pharmacological prophylaxis. The third group took a combined therapy, and the groups were consisted of 20 patients. Patients were assessed with caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI), and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3 times throughout the study, and the results were compared with relevant statistical tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 1-Vestibular Migraine diagnosis according to International Classification of Headache Disorders (3 rd edition-Beta version) 2- No history of vestibular rehabilitation or exercises

排除标准

  • History of psychiatric disorder which might interfere with compliance to study
  • Other diagnosis that might possibly cause vestibular disorder(cerebellar disorders, Meniere disease etc)
  • Anatomical defects of the inner ear or vestibular system
  • Patients who are unable to stand up straight or walk

研究组 & 干预措施

Vestibular Rehabilitation

Experimental

Adaptation Exercises The exercises were performed in horizontal and vertical planes, for a period of one minute each, three times a day.

Substitution Exercises Standing dynamic balance exercises: The patient stands and moves without walking. The patient might march in place, step forward or backward, step to the side, step up or down, or turn around.

Habituation exercises: These exercises that cause mild to moderate difficulty in daily life was given as an exercise to the patient. These exercises involved movements and positions sufficient to cause mild-to-moderate symptoms during the patient's daily activities Ambulation exercises: Exercises that include walking with head moving towards different sides.

The exercise program consisted of one session per week for a period of eight weeks. Each session lasted approximately 30-45 minutes and was conducted in the rehabilitation unit.

干预措施: Vestibular Rehabilitation (Behavioral)

Vestibular Rehabilitation+Pharmacological Therapy

Experimental

Same exercises that were applied in first group were also applied to this group.

For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.

干预措施: Control (Other)

Vestibular Rehabilitation+Pharmacological Therapy

Experimental

Same exercises that were applied in first group were also applied to this group.

For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.

干预措施: Vestibular Rehabilitation (Behavioral)

Pharmacological Therapy only

Other

Patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.

干预措施: Control (Other)

结局指标

主要结局

Dizziness Handicap Inventory

时间窗: 6 months

A standardized inventory to assess the impact of dizziness in patients' life.

Activities-specific balance confidence scale

时间窗: 6 months

A scale which is used to evaluate balance confidence of patients in some specific activities. Confidence in daily activities requiring balance is rated by subject as percentage(from %0 to %100). Higher percentage relates to better confidence in balance.

Static Posturography

时间窗: 6 months

Static posturography was performed using the NeuroCom System Version 8.0.3 (NeuroCom International Inc., Clackamas, OR, USA). Mean center of gravity (COG) sway velocity (°/s) was recorded on a static platform with eyes open (ST-EO) and closed (ST-EC) and on foam with eyes open (FO-EO) and closed (FO-EC)

次要结局

  • Vertigo attack severity(6 months)

研究者

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

Figen Gökçay

Professor in Ege University School of Medicine, Neurology Department, MD

Ege University

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