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临床试验/NCT07703085
NCT07703085进行中(未招募)不适用

"Effects of Virtual Reality Assisted Vestibular Rehabilitation Versus Conventional Vestibular Rehabilitation on Dizziness, Balance, and Gait in Patients With Benign Paroxysmal Positional Vertigo."

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
32
试验地点
1
主要终点
Dizziness Handicap Inventory (DHI)

研究概览

简要总结

This study aims to evaluate the effectiveness of two rehabilitation techniques-Virtual Reality-assisted Vestibular Rehabilitation and Conventional Vestibular Rehabilitation-in improving dizziness, balance, and gait in patients with Benign Paroxysmal Positional Vertigo (BPPV). BPPV is a common vestibular disorder that leads to episodes of dizziness, impaired balance, and gait instability, significantly affecting daily activities and quality of life. Although conventional vestibular rehabilitation is widely used, newer approaches such as Virtual Reality (VR) may provide enhanced outcomes through immersive and interactive training environments. Participants diagnosed with BPPV will be randomized into two groups: Group 1 will receive Virtual Reality-assisted vestibular rehabilitation along with routine physical therapy, and Group 2 will receive conventional vestibular rehabilitation along with routine physical therapy. The interventions will be conducted multiple times per week for a specified duration, and participants will undergo assessments for dizziness, balance, and gait before and after the intervention. Outcome measures will include tools such as the Dizziness Handicap Inventory (DHI), Berg Balance Scale (BBS), and Timed Up and Go (TUG) test. The study will compare the effects of both rehabilitation approaches, focusing on symptom reduction and functional improvement. The findings may contribute to improved rehabilitation protocols and enhance the quality of life for patients with BPPV.

详细描述

Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common peripheral vestibular disorders, caused by the displacement of otoconia within the semicircular canals of the inner ear. It is characterized by brief but intense episodes of vertigo triggered by head movements, often accompanied by dizziness, postural instability, and gait disturbances. These symptoms can significantly impair functional mobility, increase the risk of falls, and reduce overall quality of life. Vestibular Rehabilitation Therapy (VRT) is a well-established treatment approach that uses specific exercises to promote central nervous system compensation for vestibular dysfunction. Conventional VRT includes gaze stabilization exercises, balance training, and habituation exercises. While effective, some patients experience residual symptoms or limited engagement, which has led to the exploration of more innovative rehabilitation methods such as Virtual Reality (VR). This study focuses on evaluating the comparative effects of Virtual Reality-assisted Vestibular Rehabilitation and Conventional Vestibular Rehabilitation on dizziness, balance, and gait in patients with BPPV. VR-based rehabilitation offers an interactive, multisensory environment that can simulate real-life scenarios, enhance patient engagement, and promote neuroplasticity. By providing controlled visual and vestibular stimuli, VR may accelerate recovery and improve functional outcomes. Intervention Strategies: Virtual Reality-assisted Vestibular Rehabilitation: This approach utilizes VR technology to create immersive environments where patients perform balance and gaze stabilization exercises. The visual feedback provided through VR enhances sensory integration and promotes vestibular adaptation. VR training may improve motivation, adherence, and functional performance by making rehabilitation more engaging and task-oriented. Conventional Vestibular Rehabilitation: This approach includes traditional vestibular rehabilitation exercises such as gaze stabilization, habituation exercises, and balance training. These exercises aim to reduce dizziness, improve postural control, and enhance gait performance by promoting central compensation mechanisms. Study Design and Groups: This randomized controlled trial will include patients diagnosed with BPPV who meet the inclusion criteria. Participants will be randomly assigned into two groups: Group 1 (Experimental Group): Virtual Reality-assisted vestibular rehabilitation combined with routine physical therapy. Group 2 (Control Group): Conventional vestibular rehabilitation combined with routine physical therapy. The interventions will be conducted several times per week over a defined intervention period (e.g., 4-8 weeks). Each session will include structured rehabilitation exercises supervised by trained physiotherapists. Outcome Measures: The primary outcome of the study will be the reduction in dizziness severity, measured using the Dizziness Handicap Inventory (DHI), Balance assessment using the Berg Balance Scale (BBS), Gait performance using the Dynamic Gait Index (DIG) test, Functional mobility and risk of falls. Assessments will be conducted at baseline, mid-intervention (if applicable), and post-intervention to evaluate both immediate and progressive effects. Data Collection and Analysis: Data will be collected at multiple time points to evaluate changes in dizziness, balance, and gait performance. Statistical analysis will be performed using appropriate methods such as repeated measures ANOVA or mixed-model ANOVA to compare within-group and between-group differences. Post hoc analysis will be conducted to determine the effectiveness of each intervention over time. Safety and Ethics: This study will be conducted following approval from the institutional ethical review board. Informed consent will be obtained from all participants prior to inclusion in the study. All interventions will be supervised by qualified healthcare professionals to ensure participant safety. Potential risks are minimal and may include temporary dizziness, fatigue, or mild discomfort during exercises. Participants will be monitored throughout the sessions, and any adverse effects will be managed promptly. Confidentiality of participant data will be strictly maintained, and all personal information will be anonymized. Participation will be voluntary, and participants may withdraw at any time without consequences. Significance and Potential Impact: This study has the potential to contribute significantly to the field of vestibular rehabilitation by providing evidence on the comparative effectiveness of Virtual Reality-assisted and Conventional rehabilitation approaches. If VR-assisted therapy proves more effective, it may offer a more engaging, innovative, and efficient treatment option for patients with BPPV. Given the increasing interest in technology-based rehabilitation, this research may support the integration of VR into clinical practice, especially in improving patient adherence and outcomes. It may also provide a foundation for future research in vestibular disorders and neurorehabilitation. Conclusion: By comparing Virtual Reality-assisted Vestibular Rehabilitation with Conventional Vestibular Rehabilitation, this study aims to identify the most effective approach for reducing dizziness and improving balance and gait in patients with BPPV. The findings may enhance clinical decision-making and support the development of more effective, evidence-based rehabilitation strategies for 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
None

盲法说明

This study will use a triple-blind design, where the participants, participants caregivers, outcome assessor and analyst will be blinded and will be unaware of the specific intervention group they have been assigned to (i.e., whether they are receiving the VR-Assisted Vestibular Rehabilitation alone, or Conventional Vestibular Rehabilitation alone). This masking ensures that participant expectations do not influence their responses to the interventions. However, the treating therapists and study coordinators who administer the interventions and assess outcomes will not be masked, as they will be responsible for the direct management of the interventions and data collection. This design allows for an objective evaluation of the effects of the interventions while minimizing potential biases from participant expectations.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants of both genders.
  • Adults aged 18-40 years.
  • Clinically diagnosed with posterior canal Benign Paroxysmal Positional Vertigo (BPPV) confirmed by a positive Dix-Hallpike test, with a duration of at least one month since diagnosis.
  • Individuals who have undergone canalith repositioning maneuvers and demonstrate resolution of positional nystagmus.
  • Presence of residual dizziness and/or balance impairment persisting after repositioning treatment.
  • Ability to ambulate independently and safely participate in balance-related exercises.
  • Willingness to participate in the study and provide written informed consent.

排除标准

  • Central vestibular disorders
  • Cervical spine instability or severe neck pain
  • History of recent head trauma (<3 months)
  • Neurological disorders affecting balance
  • Severe visual or cognitive impairment preventing VR use
  • Patients of Vertebrobasilar insufficiency (VBI)

研究组 & 干预措施

Group A: Experimental Group (Virtual Reality Assisted Vestibular Rehabilitation)

Experimental

Participants in the VR group will receive supervised VR-based vestibular rehabilitation sessions (VR-Device Controlled) focusing on gaze stabilization, balance training, and functional gait activities using within immersive virtual environments. Each session will last approximately 30 minutes, conducted three times per week for a total duration of four weeks. Immersive VR games such as Verti-Go Home, Beat Saber, balance-based VR simulations, and optic flow tunnel games have been effectively used in vestibular rehabilitation to promote habituation, vestibulo-ocular reflex adaptation, balance control, and patient engagement.

干预措施: VR (VR-Control) (Other)

Group B: Control Group (Conventional Vestibular Rehabilitation)

Experimental

Participants in the conventional therapy group will receive standard vestibular rehabilitation (Brandt-Daroff exercises) consisting of Brandt-Daroff exercises, gaze stabilization exercises, habituation activities, and balance training. The frequency and duration of sessions will be matched to the VR group to ensure comparability.

干预措施: Conventional Vestibular Rehabilitation (Other)

结局指标

主要结局

Dizziness Handicap Inventory (DHI)

时间窗: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.

The Dizziness Handicap Inventory is a validated self-reported questionnaire consisting of 25 items that assess the physical, functional, and emotional impact of dizziness on daily activities. It demonstrates excellent internal consistency (Cronbach's α \> 0.90), strong test-retest reliability, and high responsiveness to clinical change in patients with vestibular disorders, including benign paroxysmal positional vertigo. The DHI is widely regarded as a gold-standard outcome measure for evaluating dizziness-related disability in vestibular rehabilitation research.

Berg Balance Scale (BBS)

时间窗: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.

The Berg Balance Scale is a widely used clinical assessment tool comprising 14 functional tasks designed to evaluate static and dynamic balance abilities. The BBS demonstrates high inter-rater and intra-rater reliability (ICC = 0.95-0.99) and has been shown to be sensitive in detecting balance impairments and fall risk in individuals with vestibular dysfunction. It is frequently used in both clinical practice and research settings to monitor balance improvements following vestibular rehabilitation.

Dynamic Gait Index (DGI)

时间窗: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.

The Dynamic Gait Index assesses an individual's ability to modify gait in response to varying task demands, including changes in speed, head movements, and obstacle negotiation. It has demonstrated good reliability and validity in populations with vestibular disorders and is effective in identifying gait instability and fall risk. The DGI is commonly employed to evaluate functional gait improvements following vestibular and balance rehabilitation interventions.

次要结局

未报告次要终点

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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