Vestibular HypofunctionNCT06517446
Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction
A study testing Optokinetic Virtual Reality Stimulation, Conventional rehabilitation program based on Cawthorne Cooksey exercises and VR+OKS in people with Vestibular Hypofunction, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vestibular Hypofunction
- What is being tested?
- Optokinetic Virtual Reality Stimulation, Conventional rehabilitation program based on Cawthorne Cooksey exercises and VR+OKS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2025to 7 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having bilateral vestibular hypofunction
- Having a visual impairment,
- Having a neurological disorder
- Inability to communicate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli Health and Technology University
Kocaeli, 41000
Kocaeli Health and Technology, University, 0850 450 2828, info@kocaelisaglik.edu.tr
About this study
Official title: Effect of Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction Patients
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.
- Conditions
- Vestibular Hypofunction
- Being tested
- Optokinetic Virtual Reality Stimulation, Conventional rehabilitation program based on Cawthorne Cooksey exercises, VR+OKS
- Keywords
- Unilateral Vestibular Hypofunction, Virtual Reality, Optokinetic stimulation, Motion Sickness
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optokinetic Virtual Reality StimulationOther
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 exercisesOther
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+OKSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (VR Group) | Experimental | Participants will receive a structured conventional vestibular rehabilitation program for eight weeks, once a week, in 45-minute sessions supervised by a physiotherapist. The program will be individualized based on Cawthorne-Cooksey exercises and progressively advanced with the guidance of a vestibular therapist. Additionally, participants will be provided with a home exercise program, to be performed twice daily (morning and evening), with 10 repetitions each time. Receives: Other: Conventional rehabilitation program based on Cawthorne Cooksey exercises |
| Group 2 (OKS Group) | Experimental | 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. The visual stimulus scene will feature colorful balloons moving in circular patterns, both clockwise and counterclockwise. Participants will be instructed to focus on a red balloon within the scene. The initial session duration will be set at 30 seconds and will be gradually increased up to 150 seconds depending on the participant's tolerance. Each session will include three repetitions of optokinetic stimulation. Receives: Other: Optokinetic Virtual Reality Stimulation |
| Group 3 (VR+OKS Group) | Experimental | Participants in this group will receive both the vestibular rehabilitation program and the optokinetic stimulation described above. Both interventions will be administered simultaneously over an 8-week period, in accordance with the respective protocols. Receives: Other: VR+OKS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Impact Scale (HIT-6):
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.
Measured: 8 Weeks
Motion Sickness Severity Scale (MSSS)
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).
Measured: 8 Weeks
Simulator Sickness Survey (SHA)
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".
Measured: 8 Weeks
Secondary outcomes (2)
Fatigue Severity Scale (FSS)
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).
Measured: 8 Weeks
Dizziness Handicap Inventory (DHI)
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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start7 Sep 2025
- Primary completion7 Oct 2025
- Study completion7 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular HypofunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Sever, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517446
- Sponsor's protocol ID
- EBRUDOKTORA
- Status last verified
- Mar 2026
- First submitted
- 8 Jul 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction Patients
- ClinicalTrials.gov ID
- NCT06517446
- Acronym / sponsor ID
- EBRUDOKTORA
- Conditions
- Vestibular Hypofunction
- Keywords
- Unilateral Vestibular Hypofunction, Virtual Reality, Optokinetic stimulation, Motion Sickness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 May 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (VR Group) | Experimental | Other: Conventional rehabilitation program based on Cawthorne Cooksey exercisesParticipants will receive a structured conventional vestibular rehabilitation program for eight weeks, once a week, in 45-minute sessions supervised by a physiotherapist. The program will be individualized based on Cawthorne-Cooksey exercises and progressively advanced with the guidance of a vestibular therapist. Additionally, participants will be provided with a home exercise program, to be performed twice daily (morning and evening), with 10 repetitions each time. |
| Group 2 (OKS Group) | Experimental | Other: Optokinetic Virtual Reality StimulationOptokinetic 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. The visual stimulus scene will feature colorful balloons moving in circular patterns, both clockwise and counterclockwise. Participants will be instructed to focus on a red balloon within the scene. The initial session duration will be set at 30 seconds and will be gradually increased up to 150 seconds depending on the participant's tolerance. Each session will include three repetitions of optokinetic stimulation. |
| Group 3 (VR+OKS Group) | Experimental | Other: VR+OKSParticipants in this group will receive both the vestibular rehabilitation program and the optokinetic stimulation described above. Both interventions will be administered simultaneously over an 8-week period, in accordance with the respective protocols. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Having bilateral vestibular hypofunction
- Having a visual impairment,
- Having a neurological disorder
- Inability to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optokinetic Virtual Reality StimulationThe 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. | Other | Group 2 (OKS Group) |
| Conventional rehabilitation program based on Cawthorne Cooksey exercisesThe 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. | Other | Group 1 (VR Group) |
| VR+OKSThe 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. | Other | Group 3 (VR+OKS Group) |
Primary outcome
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.
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).
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".
2 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: 8 Weeks
Dizziness Handicap Inventory (DHI)
Time frame: 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optokinetic Virtual Reality Stimulation, Conventional rehabilitation program based on Cawthorne Cooksey exercises and VR+OKS in people with Vestibular Hypofunction, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru SEVER, Doktora, PT (05336824227, fztebrusever@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Scale (HIT-6): (time frame: 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.