Virtual RealityNCT04769323
Use of Virtual Reality Devices for Vestibular Rehabilitation
A study testing Virtual Reality and Traditional home exercises in people with Virtual Reality, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the superiority of virtual reality-supported vestibular rehabilitation exercises over conventional vestibular rehabilitation exercises in patients with complaints such as vertigo, loss of balance, falling, and gait imbalance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality and Traditional home exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Complaining dizziness and/or instability for more than 3 months
- Patients aged 18 and over and under 65
Who cannot join
- Ear disease, head injury
- Ototoxic drug use
- Neurological and psychiatric illness that causes cooperation disorder
- Patients with orthopedic and systemic disorders that prevent exercising
- Patients with active malignancies
- Diseases that affect the use of glasses (epilepsy, vision loss, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Virtual Reality Devices for Vestibular Rehabilitation in Patients with Vestibular Hypofunction
The aim of this study is to investigate the superiority of virtual reality-supported vestibular rehabilitation exercises over conventional vestibular rehabilitation exercises in patients with complaints such as vertigo, loss of balance, falling, and gait imbalance.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality, Traditional home exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.
Traditional home exercisesOther
Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 use virtual reality. Receives: Device: Virtual Reality |
| Group 2 | Experimental | Group 2 do traditional home exercises. Receives: Other: Traditional home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posturography
Posturography; It gives numerical data by comparing the data obtained from these three systems, whichever is caused by the patient's balance disorder, somatosensory system affected, visual system affected, or vestibular system affected.
Measured: 1 year
Subjective Visual Vertical
Subjective visual vertical test, measures the functions of the utricular end organ.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start21 Feb 2021
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769323
- Sponsor's protocol ID
- 8
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2021
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality Devices for Vestibular Rehabilitation in Patients with Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT04769323
- Acronym / sponsor ID
- 8
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 24 Feb 2021 (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 aim of this study is to investigate the superiority of virtual reality-supported vestibular rehabilitation exercises over conventional vestibular rehabilitation exercises in patients with complaints such as vertigo, loss of balance, falling, and gait imbalance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Virtual RealityGroup 1 use virtual reality. |
| Group 2 | Experimental | Other: Traditional home exercisesGroup 2 do traditional home exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complaining dizziness and/or instability for more than 3 months
- Patients aged 18 and over and under 65
Key exclusion criteria (6 listed)
- Ear disease, head injury
- Ototoxic drug use
- Neurological and psychiatric illness that causes cooperation disorder
- Patients with orthopedic and systemic disorders that prevent exercising
- Patients with active malignancies
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 |
|---|---|---|
| Virtual RealityVestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness. | Device | Group 1 |
| Traditional home exercisesVestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness. | Other | Group 2 |
Primary outcome
Posturography
Time frame: 1 year
Posturography; It gives numerical data by comparing the data obtained from these three systems, whichever is caused by the patient's balance disorder, somatosensory system affected, visual system affected, or vestibular system affected.
Subjective Visual Vertical
Time frame: 1 year
Subjective visual vertical test, measures the functions of the utricular end organ.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- 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. This study is not recruiting at the moment.
Fazıl N Ardıç, MD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Traditional home exercises in people with Virtual Reality, run by Pamukkale University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 26 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posturography (time frame: 1 year). The study lists 2 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 26 Mar 2025.