Virtual RealityNCT05069701
The Effect of Different Head and Trunk Positions on SVV in Healthy Individuals
A study testing SVV test in people with Virtual Reality, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Aim: To obtain standardization data in static virtual SVV and dynamic virtual SVV tests according to different head and body positions by keeping up with developing technologies. In this way, it is planned to evaluate the treatment responses of patients who receive vestibular rehabilitation in a healthier way. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- SVV test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2021to 10 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers
- Volunteers over 18 years old
Who cannot join
- Patients with impaired cooperation
- Musculoskeletal or systemic presence of disease
- Past ear disease
- Patients who have experienced dizziness
- Presence of central nervous system pathology
- Patients who have used ototoxic drugs
- Patients whose use of glasses may cause problems (epilepsy, vision loss, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Head and Trunk Positions on Static Virtual SVV and Dynamic Virtual SVV in Healthy Individuals: A Standardization Study
Aim: To obtain standardization data in static virtual SVV and dynamic virtual SVV tests according to different head and body positions by keeping up with developing technologies. In this way, it is planned to evaluate the treatment responses of patients who receive vestibular rehabilitation in a healthier way.
- Conditions
- Virtual Reality
- Being tested
- SVV test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVV testDiagnostic test
SVV test will be done with virtual reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | SVV test will be done. Receives: Diagnostic Test: SVV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static SVV test
For commercially available VR Subjective Visual vertical(SVV), VIRTUALIS® PHYSIO VR[SVV and Dynamic SVV](Virtualis, France) was used. The bar angles are given in a random order. The system consists of glasses, computer and hand control. When patients wear their glasses, they can see only a light bar in Static SVV, and points rotating left or right on the background of the light bar in Dynamic SVV. No light can enter the glasses. The glasses have a sensor that detects the angle of the head. The starting point of the bar can be adjusted randomly to different angles by the computer. The visual background rotation rate for dynamic SVV was determined as ±30°/sec. The subject should adjust the bar in the vertical position using the right/left arrows on the controller. When verticality is confirmed by pressing the set button in the middle of the control unit, the computer records the angle of the bar and the position of the head.
Measured: 1 month
Dynamic SVV test
For commercially available VR Subjective Visual vertical(SVV), VIRTUALIS® PHYSIO VR[SVV and Dynamic SVV](Virtualis, France) was used. The bar angles are given in a random order. The system consists of glasses, computer and hand control. When patients wear their glasses, they can see only a light bar in Static SVV, and points rotating left or right on the background of the light bar in Dynamic SVV. No light can enter the glasses. The glasses have a sensor that detects the angle of the head. The starting point of the bar can be adjusted randomly to different angles by the computer. The visual background rotation rate for dynamic SVV was determined as ±30°/sec. The subject should adjust the bar in the vertical position using the right/left arrows on the controller. When verticality is confirmed by pressing the set button in the middle of the control unit, the computer records the angle of the bar and the position of the head.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start10 Jul 2021
- Primary completion10 Oct 2022
- Study completion10 Dec 2022
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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 Necdet Ardıç, Professor, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069701
- Sponsor's protocol ID
- 9
- Status last verified
- Jan 2022
- First submitted
- 26 Sep 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Head and Trunk Positions on Static Virtual SVV and Dynamic Virtual SVV in Healthy Individuals: A Standardization Study
- ClinicalTrials.gov ID
- NCT05069701
- Acronym / sponsor ID
- 9
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 6 Oct 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.
Aim: To obtain standardization data in static virtual SVV and dynamic virtual SVV tests according to different head and body positions by keeping up with developing technologies. In this way, it is planned to evaluate the treatment responses of patients who receive vestibular rehabilitation in a healthier way.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Diagnostic Test: SVV testSVV test will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers
- Volunteers over 18 years old
Key exclusion criteria (7 listed)
- Patients with impaired cooperation
- Musculoskeletal or systemic presence of disease
- Past ear disease
- Patients who have experienced dizziness
- Presence of central nervous system pathology
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 |
|---|---|---|
| SVV testSVV test will be done with virtual reality glasses. | Diagnostic test | Healthy volunteers |
Primary outcome
Static SVV test
Time frame: 1 month
For commercially available VR Subjective Visual vertical(SVV), VIRTUALIS® PHYSIO VR[SVV and Dynamic SVV](Virtualis, France) was used. The bar angles are given in a random order. The system consists of glasses, computer and hand control. When patients wear their glasses, they can see only a light bar in Static SVV, and points rotating left or right on the background of the light bar in Dynamic SVV. No light can enter the glasses. The glasses have a sensor that detects the angle of the head. The starting point of the bar can be adjusted randomly to different angles by the computer. The visual background rotation rate for dynamic SVV was determined as ±30°/sec. The subject should adjust the bar in the vertical position using the right/left arrows on the controller. When verticality is confirmed by pressing the set button in the middle of the control unit, the computer records the angle of the bar and the position of the head.
Dynamic SVV test
Time frame: 1 month
For commercially available VR Subjective Visual vertical(SVV), VIRTUALIS® PHYSIO VR[SVV and Dynamic SVV](Virtualis, France) was used. The bar angles are given in a random order. The system consists of glasses, computer and hand control. When patients wear their glasses, they can see only a light bar in Static SVV, and points rotating left or right on the background of the light bar in Dynamic SVV. No light can enter the glasses. The glasses have a sensor that detects the angle of the head. The starting point of the bar can be adjusted randomly to different angles by the computer. The visual background rotation rate for dynamic SVV was determined as ±30°/sec. The subject should adjust the bar in the vertical position using the right/left arrows on the controller. When verticality is confirmed by pressing the set button in the middle of the control unit, the computer records the angle of the bar and the position of the head.
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 4 Jan 2023.
Related trials for Virtual Reality
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
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 Necdet Ardıç, Professor 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 SVV test 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 7 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 4 Jan 2023. 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?
Static SVV test (time frame: 1 month). 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 4 Jan 2023.