CybersicknessNCT06206213
Investigation of the Effects of Two Types of Locomotion in the Virtual Environment
An observational study of Cybersickness, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Virtual Reality (VR) is a technology that enables individuals to engage in a computer-generated, three-dimensional (3D) environment by utilizing specialized electronic equipment. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cybersickness
- What is being tested?
- Assessment of two different locomotion types.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2023to 4 Mar 2024
- Phase
- Observational
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy university students who are aged between 18 to 30.
Who may be able to join
- Young Adults between 18 and 30 years old.
- Able to understand and follow the researchers' instructions.
- Have no pain or any medical illness.
- Have normal or corrected to normal vision.
- Volunteering to participate in experiments.
Who cannot join
- Having any medical problem that could affect physical movement or balance (e.g., vestibular, sensory, or musculoskeletal impairments)
- Having any visual problems.
- Having any neurological disorder.
- Using an additional assistive device.
- Have had a middle ear infection in the past month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Two Types of Locomotion in the Virtual Environment in Terms of Postural Stability and Cybersickness.
Virtual Reality (VR) is a technology that enables individuals to engage in a computer-generated, three-dimensional (3D) environment by utilizing specialized electronic equipment. This technology allows users to explore and interact with a wide range of objects and events, enabling them to perform perspective and motor tasks (Frederick P. Brooks, 1999). VR head-mounted displays (HMDs) create full immersion in the virtual environment by projecting images on screens positioned very close to the eyes (Turnbull \& Phillips, 2017).
The quick development of this technology has made it more affordable and available, consequently, its utilization is also increasing. It has applications in various fields, for example, it is widely used as a training platform for astronauts, soldiers, and treatment purposes in rehabilitation (Xie et al., 2021). The reason why many sectors urge to take advantage of VR is because they could promote motor learning by generating an environment, scenario, or activity that allows for the user practice motor skills with simple tools. Simultaneously, VR provides the possibility of repeating the same task at any moment, modifying factors such as level of complexity, time, and intensity of the practice (Lledó et al., 2016).
Read more
Despite the great expansion of virtual technology, cybersickness continues to be a problem that prevents it from being used fluently (Tian et al., 2022). Cybersickness is a term established to describe the unpleasant sensation that evokes from the use of virtual reality technology (McCauley \& Sharkey, 1992). Cybersickness appears with symptoms like motion sickness symptoms, the ones we feel while using vehicle such as nausea, dizziness, fatigue, and blurred vision (Laviola, 2000). In various research studies, this phenomenon has been mentioned in different terms, such as simulator sickness or VR sickness. There are several theories trying to explain why individuals develop these symptoms when they are in the car or using HMDs, however, just two theories are considered the most accepted. First theory is the Sensory Conflict Theory that was proposed by Reason \& Brand (1975) while the other one is the Postural Instability Theory, developed by Riccio \& Stoffregen (1991).
There are several factors that affect the severity of cybersickness while using HMDs and some studies have already discussed them (Tian et al., 2022). One of the main factors in Interaction; Navigation method and controllability. Different locomotion styles, such as steering walking, or teleportation, have been investigated to the virtual environment for the purpose of navigating and showed that the choice of the locomotion style would heavily impact the user experience (Al Zayer et al., 2020).
From this point, our study is aiming to compare the difference between the most used locomotion style: controller-based steering, and the Walk in place (WIP), in the context of postural control and cybersickness. We are also planning to investigate other factors affecting the results, such as personal factors; gender, previous experience, and individual's susceptibility to motion sickness.
This study including healthy young volunteers (18-30-year-olds). They started to be collected from November 2023 and will continue until February 2024 in Yeditepe University Physiotherapy and Rehabilitation department laboratory.
Participants will be asked to fill in an online form or conduct a brief interview to collect their demographic information. They will be asked about their age, height (cm), weight (kg), body mass index (BMI), gender (female / male), Medical History, gaming experience, hand and leg preference and Susceptibility to motion sickness. Then, postural stability, motion sickness measurements and heart rate (HR) will be taken before and after each experimental trial.
All Participants will play a game called "Freedom locomotion VR" a 3D virtual environment allowing the player to do several activities in it. All participants will be immerged in this virtual environment twice (two sessions) and have the freedom to do what they like in it. However, In each session, they will use one the two locomotion types that the game provides, the hand controller (HC) based and walking in place (WIP) based locomotion. To compare the effect of each of the two locomotion styles, each participant will play the game two times to be able to try both locomotion types. Postural control, motion sickness symptoms and heart rate will be tested after each session to measure the different in the effect of each type of locomotion.
As this research is including one group who will be measured multiple times in the experiment, repeated measures one-way analysis of variance (ANOVA) would be the best statistical test to use to investigate the difference.
- Conditions
- Cybersickness
- Being tested
- Assessment of two different locomotion types.
- Keywords
- Postural Control, Virtual Reality, Locomotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of two different locomotion types.Behavioural
Exposure to virtual environment by the HMD in two different locomotion styles.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Young University Students | This study involves just one group which will be consist of 40 healthy young adults (university students). It will include both males and females and all of them will be exposed to the same protocol. Receives: Behavioral: Assessment of two different locomotion types. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Simulator Sickness symptoms: Simulator Sickness Questionnaire (SSQ)
Simulator Sickness Questionnaire (SSQ) is a short questionnaire that use to evaluate the symptoms occur with the exposure of virtual reality. It is used to determine the severity of simulator sickness symptoms by giving a score of 16 different items. The severity of each symptom in this questionnaire is measured on a four-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = Severe). Symptoms in SSQ are determined according to the severity of 3 main factors:
Nausea (such as sweating, difficulty concentrating, stomach awareness) Oculomotor Disturbances (such as headache, eyestrain, blurred vision) Disorientation (head fullness, eyesight, dizziness, vertigo)
Measured: 2 minutes
Assessment of Postural Control: Prokin PK 252, the proprioceptive-stabilometric assessment device
The Prokin device (Prokin PK 252) is a proprioceptive system used for static and dynamic balance assessment and training. For this experiment, "Static Stability Assessment Program" will be chosen to provide detailed and precise data of each participant while static standing through the stabilometry platform. Stabilometry allows participants to be evaluated by detecting the oscillation of the Centre of Pressure (CoP) during static standing.
Measured: 10 min
Secondary outcomes (1)
Assessment of Motion sickness susceptibility: The motion sickness susceptibility questionnaire - Short form (MSSQ-Short)
MSSQ is used to evaluate the participants' susceptibility to motion sickness. The questionnaire asks about signs of feeling uncomfortable, nausea, and vomiting in different situations to determine which type of movement is causing motion sickness. The participants will answer according to their previous experiences.
Measured: 2-3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start13 Nov 2023
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CybersicknessStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Yazıcı Mutlu, Yeditepe University
- Investigators
- Çiğdem Yazici Mutlu, PhD, Study director, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206213
- Sponsor's protocol ID
- HMDs effect on body posture
- Status last verified
- Nov 2024
- First submitted
- 4 Jan 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brooks FP. What's real about virtual reality?. IEEE Computer graphics and applications. 1999 Nov;19(6):16-27.
Turnbull PRK, Phillips JR. Ocular effects of virtual reality headset wear in young adults. Sci Rep. 2017 Nov 23;7(1):16172. doi: 10.1038/s41598-017-16320-6.
PubMed 29170432Xie B, Liu H, Alghofaili R, Zhang Y, Jiang Y, Lobo FD, Li C, Li W, Huang H, Akdere M, Mousas C. A review on virtual reality skill training applications. Frontiers in Virtual Reality. 2021 Apr 30;2:645153.
Lledo LD, Diez JA, Bertomeu-Motos A, Ezquerro S, Badesa FJ, Sabater-Navarro JM, Garcia-Aracil N. A Comparative Analysis of 2D and 3D Tasks for Virtual Reality Therapies Based on Robotic-Assisted Neurorehabilitation for Post-stroke Patients. Front Aging Neurosci. 2016 Aug 26;8:205. doi: 10.3389/fnagi.2016.00205. eCollection 2016.
PubMed 27616992Tian N, Lopes P, Boulic R. A review of cybersickness in head-mounted displays: raising attention to individual susceptibility. Virtual Reality. 2022 Dec;26(4):1409-41.
McCauley ME, Sharkey TJ. Cybersickness: Perception of self-motion in virtual environments. Presence: Teleoperators & Virtual Environments. 1992 Aug 1;1(3):311-8.
LaViola Jr JJ. A discussion of cybersickness in virtual environments. ACM Sigchi Bulletin. 2000 Jan 1;32(1):47-56.
Reason, J.T. and Brand, J.J., 1975. Motion sickness. Academic press.
Riccio GE, Stoffregen TA. An ecological theory of motion sickness and postural instability. Urbana. 1991;100:6180.
Al Zayer M, MacNeilage P, Folmer E. Virtual Locomotion: A Survey. IEEE Trans Vis Comput Graph. 2020 Jun;26(6):2315-2334. doi: 10.1109/TVCG.2018.2887379. Epub 2018 Dec 18.
PubMed 30575541
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Two Types of Locomotion in the Virtual Environment in Terms of Postural Stability and Cybersickness.
- ClinicalTrials.gov ID
- NCT06206213
- Acronym / sponsor ID
- HMDs effect on body posture
- Conditions
- Cybersickness
- Keywords
- Postural Control, Virtual Reality, Locomotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 16 Jan 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.
Virtual Reality (VR) is a technology that enables individuals to engage in a computer-generated, three-dimensional (3D) environment by utilizing specialized electronic equipment. This technology allows users to explore and interact with a wide range of objects and events, enabling them to perform perspective and motor tasks (Frederick P. Brooks, 1999). VR head-mounted displays (HMDs) create full immersion in the virtual environment by projecting images on screens positioned very close to the eyes (Turnbull \& Phillips, 2017).
The quick development of this technology has made it more affordable and available, consequently, its utilization is also increasing. It has applications in various fields, for example, it is widely used as a training platform for astronauts, soldiers, and treatment purposes in rehabilitation (Xie et al., 2021). The reason why many sectors urge to take advantage of VR is because they could promote motor learning by generating an environment, scenario, or activity that allows for the user practice motor skills with simple tools. Simultaneously, VR provides the possibility of repeating the same task at any moment, modifying factors such as level of complexity, time, and intensity of the practice (Lledó et al., 2016).
Despite the great expansion of virtual technology, cybersickness continues to be a problem that prevents it from being used fluently (Tian et al., 2022). Cybersickness is a term established to describe the unpleasant sensation that evokes from the use of virtual reality technology (McCauley \& Sharkey, 1992). Cybersickness appears with symptoms like motion sickness symptoms, the ones we feel while using vehicle such as nausea, dizziness, fatigue, and blurred vision (Laviola, 2000). In various research studies, this phenomenon has been mentioned in different terms, such as simulator sickness or VR sickness. There are several theories trying to explain why individuals develop these symptoms when they are in the car or using HMDs, however, just two theories are considered the most accepted. First theory is the Sensory Conflict Theory that was proposed by Reason \& Brand (1975) while the other one is the Postural Instability Theory, developed by Riccio \& Stoffregen (1991).
There are several factors that affect the severity of cybersickness while using HMDs and some studies have already discussed them (Tian et al., 2022). One of the main factors in Interaction; Navigation method and controllability. Different locomotion styles, such as steering walking, or teleportation, have been investigated to the virtual environment for the purpose of navigating and showed that the choice of the locomotion style would heavily impact the user experience (Al Zayer et al., 2020).
From this point, our study is aiming to compare the difference between the most used locomotion style: controller-based steering, and the Walk in place (WIP), in the context of postural control and cybersickness. We are also planning to investigate other factors affecting the results, such as personal factors; gender, previous experience, and individual's susceptibility to motion sickness.
This study including healthy young volunteers (18-30-year-olds). They started to be collected from November 2023 and will continue until February 2024 in Yeditepe University Physiotherapy and Rehabilitation department laboratory.
Participants will be asked to fill in an online form or conduct a brief interview to collect their demographic information. They will be asked about their age, height (cm), weight (kg), body mass index (BMI), gender (female / male), Medical History, gaming experience, hand and leg preference and Susceptibility to motion sickness. Then, postural stability, motion sickness measurements and heart rate (HR) will be taken before and after each experimental trial.
All Participants will play a game called "Freedom locomotion VR" a 3D virtual environment allowing the player to do several activities in it. All participants will be immerged in this virtual environment twice (two sessions) and have the freedom to do what they like in it. However, In each session, they will use one the two locomotion types that the game provides, the hand controller (HC) based and walking in place (WIP) based locomotion. To compare the effect of each of the two locomotion styles, each participant will play the game two times to be able to try both locomotion types. Postural control, motion sickness symptoms and heart rate will be tested after each session to measure the different in the effect of each type of locomotion.
As this research is including one group who will be measured multiple times in the experiment, repeated measures one-way analysis of variance (ANOVA) would be the best statistical test to use to investigate the difference.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Young University Students | – | Behavioral: Assessment of two different locomotion types.This study involves just one group which will be consist of 40 healthy young adults (university students). It will include both males and females and all of them will be exposed to the same protocol. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy university students who are aged between 18 to 30.
Key inclusion criteria (5 listed)
- Young Adults between 18 and 30 years old.
- Able to understand and follow the researchers' instructions.
- Have no pain or any medical illness.
- Have normal or corrected to normal vision.
- Volunteering to participate in experiments.
Key exclusion criteria (5 listed)
- Having any medical problem that could affect physical movement or balance (e.g., vestibular, sensory, or musculoskeletal impairments)
- Having any visual problems.
- Having any neurological disorder.
- Using an additional assistive device.
- Have had a middle ear infection in the past month.
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 |
|---|---|---|
| Assessment of two different locomotion types.Exposure to virtual environment by the HMD in two different locomotion styles. | Behavioural | Healthy Young University Students |
Primary outcome
Assessment of Simulator Sickness symptoms: Simulator Sickness Questionnaire (SSQ)
Time frame: 2 minutes
Simulator Sickness Questionnaire (SSQ) is a short questionnaire that use to evaluate the symptoms occur with the exposure of virtual reality. It is used to determine the severity of simulator sickness symptoms by giving a score of 16 different items. The severity of each symptom in this questionnaire is measured on a four-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = Severe). Symptoms in SSQ are determined according to the severity of 3 main factors: Nausea (such as sweating, difficulty concentrating, stomach awareness) Oculomotor Disturbances (such as headache, eyestrain, blurred vision) Disorientation (head fullness, eyesight, dizziness, vertigo)
Assessment of Postural Control: Prokin PK 252, the proprioceptive-stabilometric assessment device
Time frame: 10 min
The Prokin device (Prokin PK 252) is a proprioceptive system used for static and dynamic balance assessment and training. For this experiment, "Static Stability Assessment Program" will be chosen to provide detailed and precise data of each participant while static standing through the stabilometry platform. Stabilometry allows participants to be evaluated by detecting the oscillation of the Centre of Pressure (CoP) during static standing.
1 secondary outcome
Assessment of Motion sickness susceptibility: The motion sickness susceptibility questionnaire - Short form (MSSQ-Short)
Time frame: 2-3 minutes
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 29 Nov 2024.
- BackgroundBrooks FP. What's real about virtual reality?. IEEE Computer graphics and applications. 1999 Nov;19(6):16-27.
- Background: PubMed 29170432Turnbull PRK, Phillips JR. Ocular effects of virtual reality headset wear in young adults. Sci Rep. 2017 Nov 23;7(1):16172. doi: 10.1038/s41598-017-16320-6.
- BackgroundXie B, Liu H, Alghofaili R, Zhang Y, Jiang Y, Lobo FD, Li C, Li W, Huang H, Akdere M, Mousas C. A review on virtual reality skill training applications. Frontiers in Virtual Reality. 2021 Apr 30;2:645153.
- Background: PubMed 27616992Lledo LD, Diez JA, Bertomeu-Motos A, Ezquerro S, Badesa FJ, Sabater-Navarro JM, Garcia-Aracil N. A Comparative Analysis of 2D and 3D Tasks for Virtual Reality Therapies Based on Robotic-Assisted Neurorehabilitation for Post-stroke Patients. Front Aging Neurosci. 2016 Aug 26;8:205. doi: 10.3389/fnagi.2016.00205. eCollection 2016.
- BackgroundTian N, Lopes P, Boulic R. A review of cybersickness in head-mounted displays: raising attention to individual susceptibility. Virtual Reality. 2022 Dec;26(4):1409-41.
- BackgroundMcCauley ME, Sharkey TJ. Cybersickness: Perception of self-motion in virtual environments. Presence: Teleoperators & Virtual Environments. 1992 Aug 1;1(3):311-8.
- BackgroundLaViola Jr JJ. A discussion of cybersickness in virtual environments. ACM Sigchi Bulletin. 2000 Jan 1;32(1):47-56.
- BackgroundReason, J.T. and Brand, J.J., 1975. Motion sickness. Academic press.
- BackgroundRiccio GE, Stoffregen TA. An ecological theory of motion sickness and postural instability. Urbana. 1991;100:6180.
- Background: PubMed 30575541Al Zayer M, MacNeilage P, Folmer E. Virtual Locomotion: A Survey. IEEE Trans Vis Comput Graph. 2020 Jun;26(6):2315-2334. doi: 10.1109/TVCG.2018.2887379. Epub 2018 Dec 18.
- Individual participant dataSharing planned: Undecided
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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.
Çiğdem Yazici Mutlu, PhD study director
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cybersickness, run by Yeditepe 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 5 inclusion and 5 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 29 Nov 2024. 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?
Assessment of Simulator Sickness symptoms: Simulator Sickness Questionnaire (SSQ) (time frame: 2 minutes). 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?
On the ClinicalTrials.gov record for NCT06206213, which also lists 10 linked publications.
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 29 Nov 2024.