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Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction

Effect of Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06517446
Enrollment
48
Registered
2024-07-24
Start date
2025-09-07
Completion date
2026-05-07
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Hypofunction

Keywords

Unilateral Vestibular Hypofunction, Virtual Reality, Optokinetic stimulation, Motion Sickness

Brief summary

The study will be conducted on patients diagnosed with UVH who apply to Prof. Dr. Mete İşeri Ear, Nose and Throat Diseases Polyclinic and Güneşli Erdem Hospital Ear, Nose and Throat and Vestibular Rehabilitation Unit. Participants will be divided into 3 groups by simple randomization (closed envelope) method. To the vestibular rehabilitation group; A conventional rehabilitation program based on structured Cawthorne Cooksey exercises will be applied for 45 minutes once a week with the support of a physiotherapist for 8 weeks. To the optokinetic stimulation group; optokinetic stimulation will be given with virtual reality glasses, and to the combined group; Participants in the vestibular exercise group will receive additional optokinetic stimulation. The application will be done once a week for 8 weeks. Inclusion criteria for the study are; diagnosed with unilateral vestibular hypofunction with VNG test, between the ages of 18-65, class A+ in the System Usability Scale (SUS) and the percentage range being between 96-100%; Exclusion criteria for the study are; Bilateral vestibular hypofunction, visual impairment, neurological disorder and inability to communicate.

Interventions

OTHEROptokinetic Virtual Reality Stimulation

The optokinetic stimulation protocol is defined as follows: * Optokinetic stimulation sessions are planned with a balloon rotation speed of 20°/s (degrees per second) during the first four weeks. In the fifth and sixth weeks, the speed will be increased to 25°/s, and in the seventh and eighth weeks, it will be raised to 30°/s. * The background screen will be set to rotate in the same direction as the balloons, with a rotation speed equal to 30-50% of the balloon rotation speed. * Session duration will start at 30 seconds and will increase to 150 seconds depending on patient tolerance as the sessions progress. * Participants will be instructed to focus on the red balloon in a moving visual scene. Optokinetic stimuli will be applied to participants in various postures: sitting, upright posture (feet together), semi-tandem stance, or tandem stance positions.

OTHERConventional rehabilitation program based on Cawthorne Cooksey exercises

The program will consist of Tracking, VOR, Neck, Static-Dynamic Balance Exercises and Walking training. These exercises depend on the patient's condition; It will be done in sitting, Romberg, semitandem, tandem and walking positions with eyes open and closed. Hard and soft grounds will be used.

OTHERVR+OKS

The optokinetic stimulation protocol is defined as follows: Optokinetic stimulation will be applied over 8 weeks with gradually increasing balloon rotation speeds: 20°/s (weeks 1-4), 25°/s (weeks 5-6), and 30°/s (weeks 7-8). The background will rotate in the same direction at 30-50% of the balloon speed. Sessions will start at 30 seconds and increase to 150 seconds based on tolerance. Participants will focus on a red balloon in a rotating visual scene, and the stimulation will be performed in various postures including sitting, feet together, semi-tandem, and tandem stance. The program will consist of Tracking, VOR, Neck, Static-Dynamic Balance Exercises and Walking training. These exercises depend on the patient's condition; It will be done in sitting, Romberg, semitandem, tandem and walking positions with eyes open and closed. Hard and soft grounds will be used.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with unilateral vestibular hypofunction with VNG test, * Being between the ages of 18-65, * Being in the A+ class on the System Usability Scale (SCS) and having a value between 96-100 percentile

Exclusion criteria

* Having bilateral vestibular hypofunction * Having a visual impairment, * Having a neurological disorder * Inability to communicate

Design outcomes

Primary

MeasureTime frameDescription
Headache Impact Scale (HIT-6):8 WeeksBayliss et al. It is a short questionnaire designed to assess migraine pain from the patient's perspective and track lost time. Each item is answered using a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, 13=always). The final score is determined from the sum of 6 items with a range from 36 to 78. Higher scores indicate greater impact.
Motion Sickness Severity Scale (MSSS)8 WeeksIt is a 7-point scale rated from 0 to 6, where participants select the item that best describes their current condition: none (0), stomach awareness or discomfort (1), mild nausea (2), moderate nausea (3), severe nausea (4). ), gagging (5) or vomiting (6).
Simulator Sickness Survey (SHA)8 WeeksIt has been widely used to evaluate various forms of disease triggered by virtual environments. 16 symptoms such as eye fatigue, nausea, sweating and headache are evaluated in 4 different severity levels (0: none, 1: mild, 2: moderate and 3: severe). Symptoms are grouped into 3 non-mutually exclusive categories representing nausea, oculomotor disturbance, and disorientation. Higher scores in each category indicate stronger perceptions of underlying disease symptoms. A total score above 20 is considered "poor-failing".

Secondary

MeasureTime frameDescription
Fatigue Severity Scale (FSS)8 WeeksIt is a 7-point scale rated from 0 to 6, where participants select the item that best describes their current condition: none (0), stomach awareness or discomfort (1), mild nausea (2), moderate nausea (3), severe nausea (4), retching (5), or vomiting (6).
Dizziness Handicap Inventory (DHI)8 WeeksIt is used to determine the physical, sensory and functional effects of vestibular system pathologies. Questions 1, 4, 8, 11, 13, 17 and 25: Physical disability; Questions 2, 9, 10, 15, 18, 20, 21, 22 and 23 examine emotional disability; Questions 3, 5, 6, 7, 12, 14, 16, 19 and 24: Refers to functional disability. For each question, the answers consist of yes (4 points), no (0 points) and sometimes (2). In scoring the subunits of the inventory, 28 points were accepted as the cut-off value to determine physical disability and 36 points to determine functional and sensory disability. High scores indicate that the patient's complaint of dizziness is severe.

Countries

Turkey (Türkiye)

Contacts

CONTACTEbru SEVER, Doktora, PT
fztebrusever@gmail.com05336824227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026