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临床试验/NCT06019104
NCT06019104已完成不适用

Investigation of the Effects of Task-Oriented Training on Balance and Gait in Patients With Peripheral Vestibular Hypofunction

Gazi University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
G-walk® spatio-temporal gait analysis system (cadence)

研究概览

简要总结

The peripheral vestibular disorder is a heterogeneous disorder that occurs due to unilateral or bilateral involvement of the peripheral vestibular organs in the inner ear, characterized by dizziness, balance disorder, visual blurring with head movements, postural instability, and gait disturbance. In the treatment of vestibular disorders, medical and surgical approaches, as well as vestibular rehabilitation are included. Vestibular rehabilitation should aim at repetitive stimulation of the vestibular sensory organs and improving peripheral sensory inputs by providing strong synaptic plasticity between the hair cells in these organs and the damaged parts of the vestibular system. According to this information, task-oriented training based on the practice of the task in the real environment with plenty of repetition seems to be a suitable method for the requirements of the treatment of vestibular disorders. This study was planned to examine the effects of task-oriented training on balance and gait in patients with peripheral vestibular disorders.

详细描述

Patients with peripheral vestibular disorders refrain from moving because of the increase in dizziness and fear of falling. These patients prefer to stay still and limit themselves even in simple daily life activities such as vacuuming, cleaning the table, and walking. From this point of view, it is thought that using the tasks in daily life or the activities that form the basis of these tasks in treatment as in task-oriented training will reduce the activity limitations caused by vestibular disorders.

In the recovery of the vestibular system, it is important to practice the functions that increase the symptoms with many repetitions. For example, symptoms that occur without head movement in the acute period after vestibular injury resolve rapidly, and disappear to a large extent as vestibular compensation develops. However, as the disease becomes chronic, losses occur in afferent inputs from the vestibular system and cause a negative effect on dynamic reflex functions. Therefore, vestibular rehabilitation should be aimed to stimulate the vestibular sensory organs repeatedly and to improve peripheral sensory inputs by providing strong synaptic plasticity between the hair cells in these organs and the damaged parts of the vestibular system. According to this information, task-oriented training based on the practice of the task in the real environment with plenty of repetition seems to be a suitable method for the requirements of the treatment of vestibular disorders.

In addition, there is evidence that task-oriented training improves balance, mobility, and gait reduces the risk of falls, and improves the quality of life in neurological diseases such as Stroke, Multiple Sclerosis, and Parkinson's disease. This information supports the investigators' idea that task-oriented training may also be beneficial in improving balance and walking performance, which are the main symptoms of peripheral vestibular disorder.

On the other hand, when the investigators examine the literature, there is no study examining the effects of task-oriented education in patients with peripheral vestibular disorders.

The primary aim of this study is to examine the effects of task-oriented training on vertigo, dizziness, balance, gait and falls in patients with peripheral vestibular disorders. The secondary aim of the investigators' study is to examine the effects of task-oriented training on disability level and quality of life in patients with peripheral vestibular disorders.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving a diagnosis of peripheral vestibular disorder by a specialist physician
  • Being between the ages of 18-65
  • Not having an inability to prevent the exercise
  • Not having an Orthopedic, Neurological, Rheumatological, etc., which may cause balance disorder.

排除标准

  • Having cognitive dysfunction that may affect the research results.
  • Having a history of cerebrovascular accident, fainting, or epilepsy
  • Being included in the vestibular rehabilitation program in the last 1 month
  • Being in the acute phase of vestibular disease
  • Having benign paroxysmal positional vertigo
  • Using vestibular suppressant and centrally acting drugs in the last 3 months

结局指标

主要结局

G-walk® spatio-temporal gait analysis system (cadence)

时间窗: 4 weeks

The cadence was assessed by G-walk® spatio-temporal gait analysis system. The gait assessments began with the standing position. The position had to be maintained for a few seconds until the end of the stabilization of the G-Walk device. On an 8 meter track, the participants were asked to walk. For a proper examination, the track's limits were delineated. The participants followed a perfectly straight line while moving at their usual pace. The participant's completion of the 8-meter track and arrival back at the starting point defined a successful trial. Cadence was the parameter that was assessed using the G-Walk.This parameter is sent to the computer after being recorded by G-walk.

Posturography

时间窗: 4 weeks

The posturography evaluation was made using the Synapsis Posturography System® (SPS®, version 3.0). All patients performed the Sensory Organization Test (SOT), this test representing the association between static and sway-referenced support in posturography under three conditions - eyes open (eo), eyes closed (ec), mislead vision. SOT objectively analyses the three sensory systems that contribute to postural control: somatosensory, visual and vestibular, by systematically eliminating useful visual or support information, creating also sensory conflict situations. We registered the results obtained under six conditions: eyes open, eyes closed and looking sway-referenced screen on static surface and sway-referenced surface. The feet position of the patient on the platform was - 2 cm spacing apart of the heels and a 30º angle between, corresponding to the foot size. Each test was performed barefoot, in standing position, 2 trials of 20 seconds for each test.

G-walk® spatio-temporal gait analysis system (speed)

时间窗: 4 weeks

The gait speed was assessed by G-walk® spatio-temporal gait analysis system. The assessment began with the participant standing still in an orthostatic standing position. The position had to be maintained for a few seconds until the end of the stabilization of the G-Walk device. The participants were instructed to walk on a 8 meter track. The boundaries of the track were marked to ensure a correct analysis. The participants walked at their natural speed along an absolutely straight path. A successful trial was characterized by the participant completing the 8-meter track and returning to the starting point. The parameter that were evaluated using the G-Walk were; speed (meter/seconds).This parameter are recorded by G-walk and transferred to the computer.

次要结局

  • The severity and frequency of vertigo and dizziness (Visual analog scale (VAS))(4 weeks)
  • Disability level and quality of life(4 weeks)

研究者

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

Yasemin Apaydın

Principal Investigator

Gazi University

研究点 (2)

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