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NCT Number: NCT06517446

Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli Health and Technology University

Kocaeli, 41000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Kocaeli Health and Technology, University

CONTACT

[email protected]

0850 450 2828

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optokinetic Virtual Reality Stimulation

Other

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.

Conventional rehabilitation program based on Cawthorne Cooksey exercises

Other

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.

VR+OKS

Other

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.

Primary outcomes

  1. Headache Impact Scale (HIT-6):

    Time frame: 8 Weeks

    Bayliss 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.

  2. Motion Sickness Severity Scale (MSSS)

    Time frame: 8 Weeks

    It 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).

  3. Simulator Sickness Survey (SHA)

    Time frame: 8 Weeks

    It 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 outcomes

  1. Fatigue Severity Scale (FSS)

    Time frame: 8 Weeks

    It 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).

  2. Dizziness Handicap Inventory (DHI)

    Time frame: 8 Weeks

    It 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.

Other outcomes

  1. Sociodemographic data form

    Time frame: 8 Weeks

    In this form; The patient's age, gender, profession, whether he/she smokes and drinks alcohol, additional diseases, previous surgeries, medications used, history of the disease, onset of the disease, etc. will be questioned.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru SEVER, Doktora, PT

CONTACT

[email protected]

05336824227

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Effect of Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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