- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06517446
Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction
Effect of Optokinetic Virtual Reality Stimulation in Unilateral Vestibular Hypofunction Patients
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ebru SEVER, Doktora, PT
- Phone Number: 05336824227
- Email: fztebrusever@gmail.com
Study Locations
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-
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Kocaeli, Turkey (Türkiye), 41000
- Recruiting
- Kocaeli Health and Technology University
-
Contact:
- Kocaeli Health and Technology, University
- Phone Number: 0850 450 2828
- Email: info@kocaelisaglik.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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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.
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|
Experimental: 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.
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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. |
|
Experimental: 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.
|
The optokinetic stimulation protocol is defined as follows:
Optokinetic stimuli will be applied to participants in various postures: sitting, upright posture (feet together), semi-tandem stance, or tandem stance positions. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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8 Weeks
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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).
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8 Weeks
|
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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".
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8 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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8 Weeks
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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.
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8 Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic data form
Time Frame: 8 Weeks
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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.
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8 Weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBRUDOKTORA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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