- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07703085
Effects of Virtual Reality Assisted Vestibular Rehabilitation Versus Conventional Vestibular Rehabilitation on Dizziness, Balance, and Gait in Patients With Benign Paroxysmal Positional Vertigo
2026년 7월 9일 업데이트: Lahore University of Biological and Applied Sciences
"Effects of Virtual Reality Assisted Vestibular Rehabilitation Versus Conventional Vestibular Rehabilitation on Dizziness, Balance, and Gait in Patients With Benign Paroxysmal Positional Vertigo."
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.
연구 개요
상태
모집하지 않고 적극적으로
상세 설명
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.
연구 유형
중재적
등록 (추정된)
32
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄
- Lahore University of Biological and Applied Sciences
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group A: Experimental Group (Virtual Reality Assisted Vestibular Rehabilitation)
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.
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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.
다른 이름들:
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실험적: Group B: Control Group (Conventional Vestibular Rehabilitation)
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.
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Participants in the conventional therapy group will receive standard vestibular rehabilitation 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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Dizziness Handicap Inventory (DHI)
기간: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
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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.
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Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
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Berg Balance Scale (BBS)
기간: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
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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.
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Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
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Dynamic Gait Index (DGI)
기간: Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
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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.
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Primary and secondary outcome measures will be assessed at baseline, 4 weeks, and 8 weeks to track changes in motor recovery and functional abilities.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Nabeela Dawood, Lahore University of Biological and Applied Sciences
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Ozdil A, Iyigun G, Balci B. Three-dimensional exergaming conjunction with vestibular rehabilitation in individuals with Benign Paroxysmal Positional Vertigo: A feasibility randomized controlled study. Medicine (Baltimore). 2024 Jul 5;103(27):e38739. doi: 10.1097/MD.0000000000038739.
- Lee JW, Yoon CY, Kim JH, Seo YJ, Kong TH. Virtual reality-based vestibular rehabilitation therapy in patients with acute unilateral vestibulopathy: a randomized controlled trial. Front Neurol. 2025 Jan 28;16:1519470. doi: 10.3389/fneur.2025.1519470. eCollection 2025.
- Xie M, Zhou K, Patro N, Chan T, Levin M, Gupta MK, Archibald J. Virtual Reality for Vestibular Rehabilitation: A Systematic Review. Otol Neurotol. 2021 Aug 1;42(7):967-977. doi: 10.1097/MAO.0000000000003155.
- Sana V, Ghous M, Kashif M, Albalwi A, Muneer R, Zia M. Effects of vestibular rehabilitation therapy versus virtual reality on balance, dizziness, and gait in patients with subacute stroke: A randomized controlled trial. Medicine (Baltimore). 2023 Jun 16;102(24):e33203. doi: 10.1097/MD.0000000000033203.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 1일
기본 완료 (추정된)
2026년 7월 30일
연구 완료 (추정된)
2026년 9월 15일
연구 등록 날짜
최초 제출
2026년 7월 9일
QC 기준을 충족하는 최초 제출
2026년 7월 9일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 9일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UBAS/ERB/26/04/037
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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