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临床试验/NCT05021939
NCT05021939已完成不适用

2-dimensional Versus 3-dimensional Virtual Reality Game Training in Individuals With Benign Paroxysmal Positional Vertigo: A Randomized Controlled Study

Eastern Mediterranean University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年8月28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
42
试验地点
2
主要终点
Gait Speed- With Horizontal Head Turns

研究概览

简要总结

Despite successful maneuver applications in the treatment of BPPV, complaints of balance problems and dizziness persist. Many studies supports the notion that virtual reality (VR) allowing visual-vestibular interaction with a large number of visual stimuli, contribute to successful outcomes in BPPV. VR applications using eye tracking algorithms and 'glasses' can be effective however. The research to date covers the VR technologies on the treatment of BPPV, however, there is no research comparing the effects of 2D and 3D VR gaming technologies with a control group. Therefore, this study aims to examine the effects of different virtual reality applications and vestibular rehabilitation on gait, reaction time, balance functions, activities of daily living, and quality of life in individuals with benign paroxysmal positional vertigo (BPPV) having residual dizziness and balance problems.

详细描述

The vestibular, visual, and somatosensory systems are all important in maintaining posture. Multiple structures of the central nervous system process and integrate afferents from these systems. The vestibular system is crucial for maintaining static and dynamic posture and balance. The vestibular system consists of two structures, peripheral and central. The peripheral vestibular system is located within the petrous bone and consists of the semicircular canals, utricle, and saccule in the inner ear that are sensitive to head movements. The semicircular canals consist of three parts: anterior, posterior and lateral semicircular canals. The semicircular canals, which are filled with a viscous fluid called endolymph, are located at right angles to each other and help to perceive the angular movements of the head. It transmits information about the peripheral vestibular system and head movements to the central systems via the vestibular nerve. In this way, it provides regulation of head, body, extremities and eye movements.

BPPV (Benign Paroxysmal Positional Vertigo) is a condition that affects the inner ear and is caused by semicircular canal dysfunction. Because the otoliths are placed in the semicircular canal and can impair their free movement, the anatomical placement of the canals is critical. BPPV is one of the most frequent peripheral vestibular illnesses with a prevalence of 20-40%. The first pathogenetic element is canalolithiasis, defined as the dissociation of the otoconia from the otolytic membrane and its free movement in the endolymph, which is seen in 80% of the patients. Cupulolithiasis is the occurrence of dizziness (vertigo) and nystagmus specific to the affected canal due to calcium carbonate crystals adhering to the canal. Because of its anatomical location, posterior semicircular canal BPPV is observed 80-90% of the time, lateral semicircular canal BPPV is seen 10-20% of the time, and anterior semicircular canal BPPV is less prevalent. BPPV often is treated with particle repositioning maneuvers once the involved canal is identified. These maneuvers are supposed to move otoconia particles out of the affected canal and back into the vestibule, where they dissolve.

Vestibular rehabilitation is another non-pharmacological intervention for BPPV. Vestibular rehabilitation can enhance general balance function, including gait, gaze, and postural stability, physical mobility, and function with activities of daily living, by integrating proprioceptive, visual, and residual vestibular function. Vestibular rehabilitation utilizes central neuroplasticity mechanisms to improve visuo-vestibular interactions and restore static and dynamic postural stability in situations where sensory input is conflicting. Vestibular rehabilitation includes adaptation, habituation, and substitution exercises. The adaptation exercises are based on the vestibular system's ability to change the magnitude of the vestibulo-ocular reflex (VOR) in response to a specific stimulus (head movement). Habituation exercises, in contrast to adaptation exercises, are based on the notion that frequent exposure to provoking stimuli such as head movements will reduce motion-provoked symptoms. Substitution exercises combine vision and somatosensory cues with vestibular cues to improve gaze and postural stability by enhancing central programming. Maneuvers are shown to be more successful than vestibular rehabilitation in the short term, although combining the two is useful for long-term functional recovery in BPPV. However, there is insufficient evidence to distinguish between different types of vestibular rehabilitation.

The positive impact of vestibular rehabilitation on balance is based on mechanisms related to the central nervous system's neural plasticity, and its goals are to promote visual stabilization, improve vestibular-visual interaction during head movements, thereby improving the standing and dynamic postural stability in conditions that produce conflicting sensory information, and decrease sensitivity to head movements. However, numerous aspects have been identified as having a detrimental impact on the outcome of vestibular rehabilitation, including poor exercise execution, the necessity for active efforts, and the patients' desire. Given the drawbacks associated with the time-consuming, repetitive, monotonous, and non-challenging aspects of vestibular rehabilitation, more efficient and cost-effective types of treatments were proposed as a potential alternative. Currently, virtual reality (VR) applications, can be outfitted with real-time simulations, interactive functions, and game features to allow for more motivated vestibular rehabilitation.

Many studies suggest that engaging virtual reality components can contribute to successful outcomes. It is claimed that it allows visual-vestibular interaction with a large number of visual stimuli, resulting in an optimal environment for better VR performance. It is suggested that this is due to the activation of target-oriented attention and the brain's neural network and that VR applications using eye-tracking algorithms and 'glasses' can be effective. In most of the studies, 2-dimensional systems (e.g. Nintendo Wii, Play station) has been used for the treatment of patients with BPPV. However, due to their proximity to the eye, head-mounted displays (3D VR gaming) may offer high-resolution images which make the users feel like they are a part of the computer-created environment. 3D technologies have been debated about their negative effects such as discomfort, visual fatigue, dizziness, headache, disorientation, motion sickness, which are indicative of VIMS (visually induced motion sickness). The most accepted explanation for VIMS is the classical conflict theory based on the mismatch between the visual, the proprioceptive, and the vestibular stimuli.

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 (Participant)

盲法说明

The participants are blind to the treatment methods

入排标准

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

入选标准

  • Diagnosis of unilateral (either posterior or lateral semicircular canal) BPPV within the last 5 years,
  • Dix hallpike test negative (inactive BPPV),
  • Recurrent and persistent dizziness,
  • Balance problems,
  • Age 25-65 years old individuals will be included in the study.

排除标准

  • Episodic and secondary BPPV,
  • Anterior semicircular canal BPPV or multi-canal BPPV,
  • Coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis and peripheral vestibular loss
  • Other neurological diagnoses (e.g., peripheral neuropathy, stroke, Parkinson's, central brain lesion)
  • Dizziness due to postural hypotension,
  • Using vestibulosuppressants, antihistamines or ototoxic medications within the previous 3 months will not be included in the study.

结局指标

主要结局

Gait Speed- With Horizontal Head Turns

时间窗: 8 week

The gait speed with horizontal head turns will be measured using a 10-meter walking test (10MWT). A conventional 10-meter walk course with acceleration and deceleration zones at each end was used to test self-selected walking speed. Individuals in the 10 MWT walk (at a preferred pace) for 10 meters without assistance, with the intermediate 6 meters being timed to allow for acceleration and deceleration. The timing is started when the patient first crosses the 2-meter mark and the timing is stoped when the patient completely passes the 8-meter mark, which allows for 2 meters of acceleration at the start and 2 meters of deceleration at the end of the course. The participant will be requested to walk in a pre-measured 10 meter area while performing head turns at approximately 30 degrees towards right and left. A total of 3 trial will be made and the average is recorded in meters per second (m/s).

Gait Speed- With Vertical Head Turns

时间窗: 8 week

The gait speed with vertical head turns will be measured using a 10-meter walking test (10MWT). A conventional 10-meter walk course with acceleration and deceleration zones at each end was used to test self-selected walking speed. Individuals in the 10 MWT walk (at a preferred pace) for 10 meters without assistance, with the intermediate 6 meters being timed to allow for acceleration and deceleration. The timing is started when the patient first crosses the 2-meter mark and the timing is stoped when the patient completely passes the 8-meter mark, which allows for 2 meters of acceleration at the start and 2 meters of deceleration at the end of the course. The participant will be requested to walk in a pre-measured 10 meter area while performing head turns at approximately 45 degrees towards up and down. A total of 3 trial will be made and the average is recorded in meters per second (m/s).

Gait Speed- Without Head Turns

时间窗: 8 week

The gait speed will be measured using a 10-meter walking test (10MWT). A conventional 10-meter walk course with acceleration and deceleration zones at each end was used to test self-selected walking speed. Individuals in the 10 MWT walk (at a preferred pace) for 10 meters without assistance, with the intermediate 6 meters being timed to allow for acceleration and deceleration. The timing is started when the patient first crosses the 2-meter mark and the timing is stoped when the patient completely passes the 8-meter mark, which allows for 2 meters of acceleration at the start and 2 meters of deceleration at the end of the course. This test will be applied without head turning. A total of 3 trial will be made and the average is recorded in meters per second (m/s).

次要结局

  • Dynamic Gait Index(8 week)
  • Choice Stepping Reaction Time Test(8 week)
  • Roll Test (Lateral Semicircular Canal Test)(8 weeks)
  • Fullerton Advanced Balance Scale(8 week)
  • Nintendo Wii Balance Board- Weight distribution(8 weeks)
  • Dizziness Handicap Inventory(8 week)
  • Dix Hallpike (Posterior Semicircular Canal Test)(8 weeks)
  • Vestibular Disorders Activities of Daily Living Scale(8 week)

研究者

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

Aytül Özdil

Research Assistant

Eastern Mediterranean University

研究点 (2)

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