Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus, and quality of life in patients with posterior canal benign paroxysmal positional vertigo - a randomized control trial protocol

Shrushti Jachak; Raghumahanti Raghuveer

doi:10.12688/f1000research.139954.1

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Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus, and quality of life in patients with posterior canal benign paroxysmal positional vertigo - a randomized control trial protocol

[version 1; peer review: 1 approved with reservations, 1 not approved]

Shrushti Jachak ¹, Raghumahanti Raghuveer¹

PUBLISHED 05 Sep 2023

Author details Author details

¹ Neuro-physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, Maharashtra, India, Wardha, Maharashtra, 442001, India

Shrushti Jachak
Roles: Conceptualization, Resources, Writing – Original Draft Preparation

Raghumahanti Raghuveer
Roles: Supervision, Validation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

BPPV (benign paroxysmal positional vertigo) is one of the most prevalent causes of vertigo.The clinical features include nausea, imbalance, nystagmus, light-headedness, dizziness, fear of fall. Various exercises and maneuvers have been proved to be beneficial till date. Many technologies had also contributed in the physical rehabilitation. Virtual rehabilitation using virtual reality (VR) is a novel innovation in therapy. Virtual reality is widely used in treating the patients and adding to get back to their day-to-day life. Occulus quest 2 is a VR device. Depending on the patient's motions, Oculus Quest enables you to interact genuinely while immersing yourself in a virtual reality. BPPV is a very common condition and Posterior canal BPPV (PC-BPPV) is commonest of all. Most of the available literature targets conventional treatment including Exercises for repositioning and adaptation of otoconia. Comparative studies between the conventional rehabilitation protocols have also been done. There is paucity of research on virtual rehabilitation in PC-BPPV. VR utilizing Oculus Quest 2, a device designed to incorporate VR environment can be used to mobilize the patients head position there by repositioning the otoconia. Lack of evidence related to Virtual rehabilitation and specifically Oculus Quest 2 emphasises the need to study its effects on BPPV outcomes like balance, dizziness, quality of life and nystagmus. In this study, an attempt is made to use the oculus quest 2 for BPPV rehabilitation in addition to standard treatment. Patients will be divided into 2 groups control and experimental. Control group will receive Brandt-droff exercise on the other hand experimental will receive occulus quest 2 game “Coaster combat” in adjunct to the conventional. Berg balance scale, nystagmus time quality of life, dizziness handicap index and vertigo symptom scale are the outcomes. Outcomes will be assed at baseline and after 4 weeks.

Keywords

Benign Paroxysmal Positional Vertigo, Virtual reality, Physiotherapy, Occulus quest, Rehabilitation, Vestibular rehabilitation.

Corresponding author: Shrushti Jachak

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Jachak S and Raghuveer R. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Jachak S and Raghuveer R. Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus, and quality of life in patients with posterior canal benign paroxysmal positional vertigo - a randomized control trial protocol [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2023, 12:1109 (https://doi.org/10.12688/f1000research.139954.1) First published: 05 Sep 2023, 12:1109 (https://doi.org/10.12688/f1000research.139954.1) Latest published: 05 Sep 2023, 12:1109 (https://doi.org/10.12688/f1000research.139954.1)

Introduction

Benign paroxysmal positional vertigo (BPPV), the abrupt sensation that you are spinning or that the interior of your head is whirling, is one of the most frequent causes of vertigo. Mild to severe vertigo can briefly be caused by BPPV. The most frequent inner ear ailment that causes vertigo or dizziness is BPPV.¹ The most typical kind of vertigo in modern culture is BPPV. The posterior canal is the most typical of them.² Moderate symptoms of positional assaults include frequent occurrences and an imbalance. BPPV reportedly afflicted every third person who had vestibular vertigo, making it likely the most common vestibular disease. 10.7 to 140 out of every 100,000 persons have BPPV. Idiopathic cases often afflict persons between the ages of 50 and 55, while children are very seldom affected. It is more commonly seen in older age groups due to the degradation of statoconia caused by demineralization, which has been established in histological examinations.³ The signs may come on abruptly or gradually over a period of days, weeks, months, or years.⁴ BPPV almost often happens when the head position changes. Some people may have symptoms whether laying down or sitting up in bed. Others may be able to see symptoms when they lean forward or back or towards the side. These symptoms usually deteriorate with time due to ordinary ear structural wear and tear.⁵ It is possible to treat BPPV. Physical therapy and conventional medicine are used to treat it. In its treatment, physical therapy plays a significant part. Numerous workout routines and techniques continue to be effective. BPPV may be treated with physical therapy, a common clinical vertigo problem.⁵ The Brandt-Daroff method (B-D) is another treatment option for BPPV sufferers, however it is not always feasible due to their movement issues. BPPV sufferers are subjected to many gaze stabilisation exercises.⁶ Balance training for patients aids in the improvement of balance in people affected by BPPV.⁷ Recent developments indicate that additional progress in physical recovery is expected. Virtual rehabilitation using virtual reality is a novel innovation in therapy.

With the aid of technological devices such special goggles with screens or gloves with sensors, a person may interact with an imagined three-dimensional environment in virtual reality (VR). The simulation model built by virtual reality gaming systems enables players engage with the computer-generated interactive environment while giving them the sense that they are in the actual world. An interactive environment created by computers is present in these systems. Such programmes enable the adoption of task-based learning strategies by giving participants an exciting and motivating experience.⁸ Using the virtual reality instrument Oculus Quest, patients may explore a digital setting. Depending on the patient’s motions, Oculus Quest enables you to interact genuinely while immersing yourself in a virtual reality.⁹ In this study, an effort is made to augment conventional treatments for BPPV patients with the use of the Oculus Quest 2. BPPV is a very common condition and PC-BPPV is commonest of all. Most of the available literature targets conventional treatment including Exercises for repositioning and adaptation of otoconia. Comparative studies between the conventional rehabilitation protocols have also been done. There is paucity of research on virtual rehabilitation in PC-BPPV. VR protocols utilizing Oculus Quest 2, a device designed to incorporate VR environment can be used to mobilize the patients head position there by repositioning the otoconia. The lack of evidence related to Virtual rehabilitation and specifically Oculus Quest 2 emphasises the need to study its effects on BPPV outcomes like balance, dizziness, quality of life and nystagmus.

Aims and objectives

The study’s goal is to assess the therapeutic benefit of oculus quest 2 guided physical therapy in patients with Posterior canal Benign Paroxysmal Positional Vertigo (PC-BPPV) in addition to conventional therapy on balance, dizziness, nystagmus, and quality of life.

1. To study the effect of virtual reality-based exercise through oculus quest 2 on balance in patients with PC-Benign Paroxysmal Positional Vertigo.
2. To study the effect of virtual reality-based exercise through oculus quest 2 on dizziness in patients with PC-Benign Paroxysmal Positional Vertigo.
3. To study the effect of virtual reality-based exercise through oculus quest 2 on quality of life in patients with PC-Benign Paroxysmal Positional Vertigo.
4. To study the effect of virtual reality-based exercise through oculus quest 2 on nystagmus time in patients with PC-Benign Paroxysmal Positional Vertigo.
5. To compare the effect of virtual reality-based exercise through oculus quest 2 in adjunct to conventional therapy in patients with PC-Benign Paroxysmal Positional Vertigo.

Trial design

Single Centric, two arm parallel open label superiority randomized controlled trial.

Protocol

Participants would be recruited from the OPD of Neuro-Physiotherapy, Aachrya Vinobha Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India for this hospital-based study.

This study will be carried out at the department of Neuro-physiotherapy at Ravi Nair Physiotherapy College, Sawangi (Meghe), Wardha, India, after approval from the institutional ethics committee of Datta Meghe Institute of Higher Education and Research, deemed to be University. A screening method will be used to choose the subjects. For subject allocation, a randomization procedure employing a computer-generated list will be used. Participants in the study will be split into two arms. With the goal to treat, Arm-A (conventional therapy) and Arm -B (conventional therapy with VR exercise using Oculus Quest 2) were randomly assigned for comparison. The trial will be open-label, and cut-off values at baseline parameters will be used to select participants while taking into account inclusion and exclusion criteria. If the study needs more participants, a second source of recruiting will be used. The active group will get VR-based exercise through Oculus Quest 2 in addition to traditional treatment, while the control group will receive Brandt-droff. Exercises to assess their effectiveness regarding balance, nystagmus, dizziness, and general quality of life. Participants will be included and evaluated during a variety of time periods, including visits 1 and 2 for subject enrolment and participant screening, baseline, and the four weeks during which primary and secondary parameters will be examined. Figure 1 depicts the study’s design.

Figure 1. Flow chart explaining procedure.

Inclusion criteria

1. Both Males and Females between 20 to 50 years, diagnosed will positive Loaded Dix-Hallpike test (as the gender has no role in the pathophysiology of BPPV and on the outcomes).
2. Patients with Dizziness Handicap Inventory score ≤ 52.
3. Patients who are willing to participate in the study.

Exclusion criteria

1. Patients with Central vestibular dysfunction, Cerebellar dysfunction, Cognitive impairments, and migraines.
2. Patients with Dizziness Handicap Inventory score ≥ 52.
3. Patients with inner ear infections and auditory dysfunctions.
4. Patients under medications.
5. Enrolment in another clinical trial involving physiotherapy or an investigational drug.

Intervention

Control group

Subjects will get 20 minutes of traditional rehabilitation training per day, 12 sessions per week, three days a week for four weeks. The patient will be given the Bandt-Droff exercise, which consists of 10 repetitions with a rest after each cycle of five sets. This traditional rehabilitation is provided by a hospital therapist. To imitate the abilities necessary in the immersive VR group, conventional therapy will be built with equal intensity and complexity. For the Brandt-daroff exercise, the patient will begin in a sitting position and swivel the head 45 degrees to one side (left), then immediately lie down on the other shoulder (right). The patient should be told to hold this posture for 30 seconds or until the vertigo disappears. The patient then gradually returns to the beginning position, keeping the hear rotation (left) until seated upright. The patient next turns his head in the other direction (right) and lies down on the opposite shoulder (left), following the same 30 second time constraints. To ensure the quality of the training, researchers in the investigation will observe and encourage all participants to actively engage in the programme.

Experimental group

A therapist at the hospital will provide subjects with 20 minutes of traditional rehabilitation and 20 minutes of virtual reality rehabilitation training each day, 12 sessions, three days a week for four weeks. The patient will begin the standard therapy in a sitting position, move their head 45 degrees to one side (to the left in this case), and then rapidly lie down on the opposing shoulder (to the right). The patient should be told to hold this posture for 30 seconds or until the dizziness passes. The patient then gently assumes the beginning posture while continuing to rotate their head to the left until they are sitting up straight. Then, while still adhering to the same 30 second time limits, the patient turns their head in the other direction (to the right) and lies down on the opposite shoulder (to the left). Subjects in the experimental group will have to finish the “Coaster Combat” game on a back-supported chair in a virtual setting during the daily 20-min VR therapy. The patient will be requested to play two sets of this game, which has a 10-minute time limit. When utilising the Oculus Quest 2, the patient may swivel their head a small amount to gaze around. This offers a very high degree of immersion and comes very near to being a genuine experience. A virtual environment provided by a VR game will eventually increase a patient’s level of interest and commitment to rehabilitation.

Outcomes

Pre and post intervention measures

Primary outcomes

1. Berg Balance Scale (BBS)
The scale was created specially to evaluate older people’s balance. It is 0.97 percent reliable. It received a total score of 56. It consists of 14 total elements, each of which has a maximum score of 4. The outcome will be reported pre-treatment and after four weeks following the treatment.
2. Dizziness Handicap Inventory (DHI).
3. The DHI items that make up the F3 (positional) subscale produced the highest scoring in the BPPV group when compared to Dix-Hallpike tests, with 75% sensitivity and 92% negative predictive value (NPV).¹⁰ The test-retest reliability of DHI is outstanding (r=0.97) and it has a great internal consistency reliability (r=0.89). The outcome will be reported pre-treatment and after four weeks following the treatment.
4. Quality of Life Scale (QOLS)
It has 16 questions; the minimum score is 16 and the maximum score is 112.
The outcome will be reported pre-treatment and after four weeks following the treatment.
5. Nystagmus time
Nystagmus time will be calculated when the patient elicits the nystagmus and when the nystagmus subsides. The outcome will be reported pre-treatment and after four weeks following the treatment.

Secondary outcome

1. Vertigo Symptom Scale Short Form
The VSS, VDI-symptom scale, and VDI-health-related quality of life scale have all demonstrated high levels of internal consistency in the Turkish translation, with corresponding Cronbach’s alpha values of 0.91, 0.85, and 0.93. Significant intraclass correlation coefficients (ICCs) of 0.83, 0.90, and 0.89, respectively, were discovered for the VSS, the VDI-symptom scale, and the VDI-health related quality of life scale over the two time periods.¹¹ The outcome will be reported pre-treatment and after four weeks following the treatment.

Sample size calculation

Sample size - 74

Formula Using Mean difference

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Variable (Vestibular symptom scale)

Mean ± SD. (Pre) result on (Vestibular symptom scale) = 15.10 ± 4.89.

Clinically relevant superiority 20% in virtual reality group = (15.10 *20)/100 = 3.02.

Difference. = 0.34 ± 0.16. (As per ref. article)

As per reference articles.

N1 = 2^{*} [{(1.64 + 0.84)}^{2} {(3.02)}^{2}] / {(0.102)}^{2} = 33

Total samples required = 33 per Group.

Considering 10% drop out = 4

Total sample size required = 37 per group

Notations:

Z_{α} = 1.64

α = Type I error at 5% at both end total 10%

Z_{β} = 0.84 (1 - β) = Power at 80 %

σ = std . dev

Ref Article: Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction.¹²

Discussion

BPPV is commonest disease which hampers the activity of daily living as it causes nystagmus, dizziness, light headedness, loss of balance and fear of fall. The goal of the study is to assess the therapeutic effectiveness of standard treatment for patients with posterior canal benign paroxysmal positional vertigo (PC-BPPV) on balance, vertigo, nystagmus, and quality of life. Virtual reality and physical therapy have both been extensively studied as potential treatments for BPPV. The Vestibular Activities and Participation Measure (VAP) score at post-intervention and the Fall Efficacy Scale (FES) score across the groups were significantly different, according to research by Jaffar et al. from 2023. The findings of the within-group analysis were significant (p=0.01).¹³ In line with this we are also using the Brandt-droff as a gold standard in this protocol. Xie et al. (2021) in the systematic review declared that virtual reality-based vestibular rehabilitation is very beneficial. However, the studies limition stated further research to be done on same. We are aiming to use VR to see its potential benefits in patients with same population.¹⁴ VeR is a successful treatment strategy that is backed by research, according to Matsumura and Murofushi’s assessment from 2021. BVP has a significant balance issue that might cause a fall and perhaps result in death. While VeR has obvious advantages for UVP, it only provides marginal advantages for BVP. However, VR, which has lately been used for VeR, is a promising technique.¹⁵ In this study we are also trying to find out the benefit of oculus quest 2. The impact of balancing vestibular rehabilitation treatment on elderly patients with benign paroxysmal positional vertigo was investigated by Ribeiro et al. (2017). Over the course of the 13 weeks, there were no between-group differences in dizziness, quality of life, or standing balance. Through examinations, significant variations in dynamic balance measures across groups were found (p 0.05 for most tests). Both groups improved across the board in the intragroup analysis, with the exception of the majority of the dynamic balance tests in the control group, which showed no change.¹⁶ We are also using the outcomes for balance as it is highly impaired in BPPV.

Analysis

Data over the outcome variables will be tested for normal distribution for the mean and standard deviation (SD), and median statistics will be positioned for finding skewed distributions and interquartile range (IQR). Results over the outcome variables will be tabulated and described using descriptive statistics. For descriptive statistics, frequency and percentages for binary and categorical variables will be tallied. All statistical analysis will be done using the free version of R programme. The inferential statistics will be examined in accordance with the following explanation.

Primary variable

Inferential statistics will be used for comparing the two groups for measurement score resulted for their mean change in primary variable (Berg balance scale, dizziness handicap inventory, quality of life, nystagmus time) and secondary variables (vertigo symptom scale) between baseline and end visits.

Baseline variables will be tested for finding significance in mean using Anova or Kruskal wallis test for more than 2 assessment period. Post-hoc (Tuckey’s or Dunccan) test will be used to find the significance difference between two group for pair-wise comparison.

Outcome variables

Outcome variables will be tested for intra difference in measurement at pre- and postvisits using paired t-test for finding the significance in mean. While for inter group difference unpaired t-test for comparison of two group & Anova for comparison of three groups will be used. Generalized models for repeated measures will be tested for different visit periods (within the group) & for comparison of three groups (between the group) to find fixed & random effects.

For non-normal distribution Mathematical algorithms will be used for conversion of the data to normal distribution. If Data over primary variable still follows the non-normal distribution, then we will use alternate nonparametric test (Chi square, Mann Whitney, Wilcoxon test, Kruskal wallis, Friedmann test).

Chi square analysis will be performed for categorial evaluation between two groups control against experimental for statistical evidence of finding significance at 5% l.o.s. (P ≤ 0.05).

T-test unpaired or alternative nonparametric test will be used for finding significance at 5% l.o.s. (P ≤ 0.05) between groups control against experimental.

Effect size over mean change difference on primary variable will be measured with corresponding 95% confidence interval (CI) & will be presented for finding the significance at 5% level.

Dissemination

Planning to publish in indexed journal and present the study in National Conference Proceedings.

Study status

Recruitment of participants is yet to be started.

Ethical considerations

Institutional Ethical Clearance has been obtained on 21/03/2023. Written informed consent will be obtained from the study participants.

IEC No – DMIHER (DU)/IEC/2023/811

CTRI Registration was obtained 24/05/2023

Data availability

No data are associated with this article.

Reporting guidelines

Zenodo: SPIRIT checklist for protocol Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus and quality of life in patients with posterior canal benign paroxysmal positional vertigo -A randomized control trial, DOI: 10.5281/zenodo.8162236.¹⁷

Acknowledgements

I would like to thank Mr. Laxmikant Umate for his assistance in designing the data analysis and calculating the sample size.

References

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2. Califano L, Salafia F, Mazzone S, et al.: Anterior canal BPPV and apogeotropic posterior canal BPPV: two rare forms of vertical canalolithiasis. Acta Otorhinolaryngol Ital Organo Uff Della Soc Ital Otorinolaringol E Chir Cerv-facc. 2014 Jun; 34(3): 189–197.
3. Hornibrook J: Benign Paroxysmal Positional Vertigo (BPPV): History, Pathophysiology, Office Treatment and Future Directions. Int J Otolaryngol. 2011; 2011: 1–13. Publisher Full Text
4. Katsarkas A: Benign paroxysmal positional vertigo (BPPV): idiopathic versus post-traumatic. Acta Otolaryngol (Stockh). 1999; 119(7): 745–749. Publisher Full Text
5. Singh PM: BENIGN PAROXYSMAL POSITIONAL VERTIGO: OUR EXPERIENCE AT A TERTIARY CARE CENTRE OF CENTRAL INDIA. Int J Sci Res. 2020 Sep 1; 1–3. Publisher Full Text
6. Mandalà M, Pepponi E, Santoro GP, et al.: Double-blind randomized trial on the efficacy of the Gufoni maneuver for treatment of lateral canal BPPV. Laryngoscope. 2013 Jul; 123(7): 1782–1786. Publisher Full Text
7. von Brevern M , Radtke A, Lezius F, et al.: Epidemiology of benign paroxysmal positional vertigo: a population based study. J. Neurol. Neurosurg. Psychiatry. 2007 Jul; 78(7): 710–715. Publisher Full Text
8. Ikbali Afsar S, Mirzayev I, Umit Yemisci O, et al.: Virtual Reality in Upper Extremity Rehabilitation of Stroke Patients: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis Off J Natl Stroke Assoc. 2018 Dec; 27(12): 3473–3478. Publisher Full Text
9. Shum LC, Valdés BA, der Loos HMV : Determining the Accuracy of Oculus Touch Controllers for Motor Rehabilitation Applications Using Quantifiable Upper Limb Kinematics: Validation Study. JMIR Biomed Eng. 2019 Jun 6; 4(1): e12291. Publisher Full Text
10. Zamyslowska-Szmytke E, Politanski P, Jozefowicz-Korczynska M: Dizziness Handicap Inventory in Clinical Evaluation of Dizzy Patients. Int J Environ Res Public Health. 2021 Feb 24; 18(5): 2210. PubMed Abstract | Publisher Full Text | Free Full Text
11. Yanik B, Külcü DG, Kurtais Y, et al.: The reliability and validity of the Vertigo Symptom Scale and the Vertigo Dizziness Imbalance Questionnaires in a Turkish patient population with benign paroxysmal positional vertigo. J Vestib Res Equilib Orientat. 2008; 18(2–3): 159–170. Publisher Full Text
12. Stankiewicz T, Gujski M, Niedzielski A, et al.: Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. Med Sci Monit Int Med J Exp Clin Res. 2020 Dec 31; 26: e930182. Publisher Full Text
13. Jaffar M, Ghous M, Ayaz M, et al.: Effects of Half-Somersault and Brandt-Daroff exercise on dizziness, fear of fall and quality of life in patients with posterior canal benign paroxysmal positional vertigo: A randomised control trial. JPMA J Pak Med Assoc. 2023 Jan; 73(1): 139–142.
14. Xie M, Zhou K, Patro N, et al.: Virtual Reality for Vestibular Rehabilitation: A Systematic Review. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2021 Aug 1; Publish Ahead of Print(7): 967–977. Publisher Full Text
15. Matsumura M, Murofushi T: Vestibular Rehabilitation after Vestibulopathy Focusing on the Application of Virtual Reality. J Otorhinolaryngol Hear Balance Med. 2021 Jun; 2(2): 5. Publisher Full Text
16. Ribeiro KMOB d F, Freitas RV d M, Ferreira LM d BM, et al.: Effects of balance Vestibular Rehabilitation Therapy in elderly with Benign Paroxysmal Positional Vertigo: a randomized controlled trial. Disabil Rehabil. 2017 Jun; 39(12): 1198–1206. PubMed Abstract | Publisher Full Text
17. Jachak S, Raghuveer R: Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus and quality of life in patients with posterior canal benign paroxysmal positional vertigo -A randomized control trial. (Version v1). Zenodo. 2023. Publisher Full Text

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Author details Author details

¹ Neuro-physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, Maharashtra, India, Wardha, Maharashtra, 442001, India

Shrushti Jachak
Roles: Conceptualization, Resources, Writing – Original Draft Preparation

Raghumahanti Raghuveer
Roles: Supervision, Validation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 05 Sep 2023, 12:1109

https://doi.org/10.12688/f1000research.139954.1

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© 2023 Jachak S and Raghuveer R. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Jachak S and Raghuveer R. Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus, and quality of life in patients with posterior canal benign paroxysmal positional vertigo - a randomized control trial protocol [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2023, 12:1109 (https://doi.org/10.12688/f1000research.139954.1)

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Open Peer Review

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Reviewer Report 12 Jun 2024

Nicolas Perez-Fernandez, Department of Otolaryngology, Clinica Universitaria de Navarra, Pamplona, Spain

Not Approved

https://doi.org/10.5256/f1000research.153278.r204278

The rationale of the study is well set. The main issue is that the main issue with which the authors are performing their study is against spontaneous resolution. As no repositioning maneuver is done (Epley or Semont) Brandt Daroff exercises ... Continue reading

The rationale of the study is well set. The main issue is that the main issue with which the authors are performing their study is against spontaneous resolution. As no repositioning maneuver is done (Epley or Semont) Brandt Daroff exercises are showing adaptation. But there is adaptation ion daily living as well spontaneous recovery. So a third arm should be needed or this has to be taken into consideration.

The inclusion criteria must be more clear. How do you classify the PSC-BPPV. Loaded Dix-Hallpike? clarify what is that

Data on the patients must be more precise: age, sex, disease duration, time since first day of vertigo, first episode ever or recurring, clinical history of concomitant disease (BP, diabetes, etc, low vitamin D, migraine, etc)

The specific protocol for virtual rehabilitation must be better explained. Why sitting? Head restrained?

The english is very poor and the academic style too.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Neurotology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report 16 Jan 2024

Oskar Rosiak, Department of Otolaryngology, Polish Mother Memorial Hospital Research Institute, Lodz, Poland

Approved with Reservations

https://doi.org/10.5256/f1000research.153278.r235035

The authors present a proposition for a clinical trial protocol on the effectiveness of VR-aided rehabilitation in Posterior Canal BPPV patients.

The general aim of the project is well described and the proposed methodology is valid, the ... Continue reading

The authors present a proposition for a clinical trial protocol on the effectiveness of VR-aided rehabilitation in Posterior Canal BPPV patients.

The general aim of the project is well described and the proposed methodology is valid, the two-arm randomized approach with both groups receiving standardized Brand-Daroff Exercises and study group receiving additional VR therapy is a good approach.

The rationale for this study is convincing, as similar studies were conducted using VR in other vestibular disorders and with good outcomes, while well-designed randomized trials are scarce.

I have some minor comments:

Figure 1 - box with VR has a second line that is illegible.

Inclusion criteria:
1. What is the rationale behind the cutoff at 50 y.o?
2. Be more specific as to the Dix-Hallpike maneuver test. Will only geotropic rotational horizontal nystagmus be accepted? or any evoked nystagmus? Will additional maneuvers be performed to account for multi-canal BBPV?
3. Instrumental measures could be useful to establish baseline vestibular function such as the vHIT

Exclusion criteria
4. Any medication? I suppose the authors should list the groups of medication.

Following abbreviations are not explained:
VeR - ???
UVP - ???
BVP- ???

English language needs major correction.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Neurootology, Virtual reality in vestibular research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Oskar Rosiak, Polish Mother Memorial Hospital Research Institute, Lodz, Poland
Nicolas Perez-Fernandez, Clinica Universitaria de Navarra, Pamplona, Spain

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Reviewer Report

5 Views

12 Jun 2024 | for Version 1

Nicolas Perez-Fernandez, Department of Otolaryngology, Clinica Universitaria de Navarra, Pamplona, Spain

5 Views Cite this report Responses(0)

Not Approved

The rationale of the study is well set. The main issue is that the main issue with which the authors are performing their study is against spontaneous resolution. As no repositioning maneuver is done (Epley or Semont) Brandt Daroff exercises are showing adaptation. But there is adaptation ion daily living as well spontaneous recovery. So a third arm should be needed or this has to be taken into consideration.

The inclusion criteria must be more clear. How do you classify the PSC-BPPV. Loaded Dix-Hallpike? clarify what is that

Data on the patients must be more precise: age, sex, disease duration, time since first day of vertigo, first episode ever or recurring, clinical history of concomitant disease (BP, diabetes, etc, low vitamin D, migraine, etc)

The specific protocol for virtual rehabilitation must be better explained. Why sitting? Head restrained?

The english is very poor and the academic style too.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Neurotology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report

7 Views

16 Jan 2024 | for Version 1

Oskar Rosiak, Department of Otolaryngology, Polish Mother Memorial Hospital Research Institute, Lodz, Poland

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Approved With Reservations

The authors present a proposition for a clinical trial protocol on the effectiveness of VR-aided rehabilitation in Posterior Canal BPPV patients.

The general aim of the project is well described and the proposed methodology is valid, the two-arm randomized approach with both groups receiving standardized Brand-Daroff Exercises and study group receiving additional VR therapy is a good approach.

The rationale for this study is convincing, as similar studies were conducted using VR in other vestibular disorders and with good outcomes, while well-designed randomized trials are scarce.

I have some minor comments:

Figure 1 - box with VR has a second line that is illegible.

Inclusion criteria:
1. What is the rationale behind the cutoff at 50 y.o?
2. Be more specific as to the Dix-Hallpike maneuver test. Will only geotropic rotational horizontal nystagmus be accepted? or any evoked nystagmus? Will additional maneuvers be performed to account for multi-canal BBPV?
3. Instrumental measures could be useful to establish baseline vestibular function such as the vHIT

Exclusion criteria
4. Any medication? I suppose the authors should list the groups of medication.

Following abbreviations are not explained:
VeR - ???
UVP - ???
BVP- ???

English language needs major correction.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Neurootology, Virtual reality in vestibular research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Therapeutic effectiveness of virtual reality-based exercise through Oculus Quest 2 on balance, dizziness, nystagmus, and quality of life in patients with posterior canal benign paroxysmal positional vertigo - a randomized control trial protocol

Abstract

Keywords

Introduction

Aims and objectives

Trial design

Protocol

Figure 1. Flow chart explaining procedure.

Inclusion criteria

Exclusion criteria

Intervention

Outcomes

Discussion

Analysis

Primary variable

Outcome variables

Dissemination

Study status

Data availability

Reporting guidelines

Acknowledgements

References

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