Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction

NCT ID: NCT06517446

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-07

Study Completion Date

2026-10-07

Brief Summary

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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.

Detailed Description

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Conditions

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Vestibular Hypofunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1 (VR Group)

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.

Group Type EXPERIMENTAL

Conventional rehabilitation program based on Cawthorne Cooksey exercises

Intervention Type 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.

Group 2 (OKS Group)

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.

Group Type EXPERIMENTAL

Optokinetic Virtual Reality Stimulation

Intervention Type 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.

Group 3 (VR+OKS Group)

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.

Group Type EXPERIMENTAL

VR+OKS

Intervention Type 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.

Interventions

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Optokinetic 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.

Intervention Type OTHER

Conventional 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.

Intervention Type OTHER

VR+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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ebru Sever

Specialist Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli Health and Technology University

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ebru SEVER, Doktora, PT

Role: CONTACT

05336824227

Facility Contacts

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Kocaeli Health and Technology, University

Role: primary

0850 450 2828

Other Identifiers

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EBRUDOKTORA

Identifier Type: -

Identifier Source: org_study_id

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