2-dimensional Versus 3-dimensional Virtual Reality Game Training in BPPV

NCT05021939 | Completed

• 1 other identifier: 2420-0107
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vertigo

Keywords

Benign paroxysmal positional vertigo; Dizziness; Virtual Reality; Vestibular Rehabilitation; Balance functions; Gait

Outcome Measures

Primary Outcomes (3)

• Gait Speed- Without Head Turns

  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).

  8 week

• Gait Speed- With Horizontal Head Turns

  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).

  8 week

• Gait Speed- With Vertical Head Turns

  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).

  8 week

Secondary Outcomes (8)

• Dix Hallpike (Posterior Semicircular Canal Test)

  8 weeks

• Roll Test (Lateral Semicircular Canal Test)

  8 weeks

• Choice Stepping Reaction Time Test

  8 week

• Fullerton Advanced Balance Scale

  8 week

• Nintendo Wii Balance Board- Weight distribution

  8 weeks

Study Arms (3)

Control Group

NO INTERVENTION

No treatment will be given to the control group. Evaluation will be done at the at the baseline and 8th week.

2-Dimensional Group

EXPERIMENTAL

In the 2-Dimensional Group, 2D VR gaming training in addition to traditional vestibular rehabilitation will be employed. In this group, the 'Verti-Go' game from the Playstation 4 VR gaming device will be played in 2D for 20-25 minutes, as well as vestibular therapy for 20-25 minutes. A total of 45-50 minutes will be given over the course of 8 weeks, 3 sessions per week. The intensity of treatment will rise with each session, depending on how well the patient cooperates. Evaluation will be done at the beginning and in the 8th week.

Other: 2-Dimensional Group

3-Dimensional Group

EXPERIMENTAL

In the 3-Dimensional Group, 3D VR gaming training in addition to traditional vestibular rehabilitation will be employed. In this group, the 'Verti-Go' game from the Playstation 4 VR gaming device with 3D glasses will be played for 20-25 minutes, as well as vestibular therapy for 20-25 minutes. A total of 45-50 minutes will be given over the course of 8 weeks, 3 sessions per week. The intensity of treatment will rise with each session, depending on how well the patient cooperates. Evaluation will be done at the beginning and in the 8th week.

Other: 3-Dimensional Group

Interventions

2-Dimensional Group OTHER

In the 2-Dimensional Group, 2D VR gaming training in addition to traditional vestibular rehabilitation will be employed. In this group, the 'Verti-Go' game from the Playstation 4 VR gaming device will be played in 2D for 20-25 minutes, as well as vestibular therapy for 20-25 minutes. A total of 45-50 minutes will be given over the course of 8 weeks, 3 sessions per week. The intensity of treatment will rise with each session, depending on how well the patient cooperates. Evaluation will be done at the beginning and in the 8th week.

2-Dimensional Group

3-Dimensional Group OTHER

In the 3-Dimensional Group, 3D VR gaming training in addition to traditional vestibular rehabilitation will be employed. In this group, the 'Verti-Go' game from the Playstation 4 VR gaming device with 3D glasses will be played for 20-25 minutes, as well as vestibular therapy for 20-25 minutes. A total of 45-50 minutes will be given over the course of 8 weeks, 3 sessions per week. The intensity of treatment will rise with each session, depending on how well the patient cooperates. Evaluation will be done at the beginning and in the 8th week.

3-Dimensional Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, Eyalet/Yerleşke, 99450, Cyprus

Location

Related Publications (9)

• Iyigun G, Kirmizigil B, Angin E, Oksuz S, Can F, Eker L, Rose DJ. The reliability and validity of the Turkish version of Fullerton Advanced Balance (FAB-T) scale. Arch Gerontol Geriatr. 2018 Sep-Oct;78:38-44. doi: 10.1016/j.archger.2018.05.022. Epub 2018 Jun 4.

  PMID: 29886283 BACKGROUND

• Meldrum D, Herdman S, Vance R, Murray D, Malone K, Duffy D, Glennon A, McConn-Walsh R. Effectiveness of conventional versus virtual reality-based balance exercises in vestibular rehabilitation for unilateral peripheral vestibular loss: results of a randomized controlled trial. Arch Phys Med Rehabil. 2015 Jul;96(7):1319-1328.e1. doi: 10.1016/j.apmr.2015.02.032. Epub 2015 Apr 2.

  PMID: 25842051 BACKGROUND

• Nada EH, Ibraheem OA, Hassaan MR. Vestibular Rehabilitation Therapy Outcomes in Patients With Persistent Postural-Perceptual Dizziness. Ann Otol Rhinol Laryngol. 2019 Apr;128(4):323-329. doi: 10.1177/0003489418823017. Epub 2019 Jan 4.

  PMID: 30607985 BACKGROUND

• Rosiak O, Krajewski K, Woszczak M, Jozefowicz-Korczynska M. Evaluation of the effectiveness of a Virtual Reality-based exercise program for Unilateral Peripheral Vestibular Deficit. J Vestib Res. 2018;28(5-6):409-415. doi: 10.3233/VES-180647.

  PMID: 30714985 BACKGROUND

• Yeh SC, Chen S, Wang PC, Su MC, Chang CH, Tsai PY. Interactive 3-dimensional virtual reality rehabilitation for patients with chronic imbalance and vestibular dysfunction. Technol Health Care. 2014;22(6):915-21. doi: 10.3233/THC-140855.

  PMID: 25159998 BACKGROUND

• Micarelli A, Viziano A, Augimeri I, Micarelli D, Alessandrini M. Three-dimensional head-mounted gaming task procedure maximizes effects of vestibular rehabilitation in unilateral vestibular hypofunction: a randomized controlled pilot trial. Int J Rehabil Res. 2017 Dec;40(4):325-332. doi: 10.1097/MRR.0000000000000244.

  PMID: 28723718 BACKGROUND

• Roettl J, Terlutter R. The same video game in 2D, 3D or virtual reality - How does technology impact game evaluation and brand placements? PLoS One. 2018 Jul 20;13(7):e0200724. doi: 10.1371/journal.pone.0200724. eCollection 2018.

  PMID: 30028839 BACKGROUND

• Hsu SY, Fang TY, Yeh SC, Su MC, Wang PC, Wang VY. Three-dimensional, virtual reality vestibular rehabilitation for chronic imbalance problem caused by Meniere's disease: a pilot study<sup/> Disabil Rehabil. 2017 Aug;39(16):1601-1606. doi: 10.1080/09638288.2016.1203027. Epub 2016 Jul 15.

  PMID: 27418422 BACKGROUND

• Ozaldemir I, Iyigun G, Malkoc M. Comparison of processing speed, balance, mobility and fear of falling between hypertensive and normotensive individuals. Braz J Phys Ther. 2020 Nov-Dec;24(6):503-511. doi: 10.1016/j.bjpt.2019.09.002. Epub 2019 Sep 23.

  PMID: 31570266 BACKGROUND

MeSH Terms

Conditions

Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Study Officials

• Aytül Özdil, PT

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

• Gözde İyigün, PhD

  Eastern Mediterranean University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are blind to the treatment methods
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 26, 2021
• Study Start: August 28, 2021
• Primary Completion: October 12, 2023
• Study Completion: November 2, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)