- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07703085
Effects of Virtual Reality Assisted Vestibular Rehabilitation Versus Conventional Vestibular Rehabilitation on Dizziness, Balance, and Gait in Patients With Benign Paroxysmal Positional Vertigo
9. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Aktivní, ne nábor
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
32
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán
- Lahore University of Biological and Applied Sciences
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
Ostatní jména:
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Dizziness Handicap Inventory (DHI)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Studijní židle: Nabeela Dawood, Lahore University of Biological and Applied Sciences
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. května 2026
Primární dokončení (Odhadovaný)
30. července 2026
Dokončení studie (Odhadovaný)
15. září 2026
Termíny zápisu do studia
První předloženo
9. července 2026
První předloženo, které splnilo kritéria kontroly kvality
9. července 2026
První zveřejněno (Aktuální)
14. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- UBAS/ERB/26/04/037
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