HealthyNCT06139900
How Virtual Reality is Impacting Balance: An Examination of Postural Stability
An observational study of Healthy, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
There are several studies examining the effects of different sensory stimuli on balance in healthy young people. Our study will especially explain how the same environment will affect postural control, when projected into VR environment. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Assessment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2021to 20 Jun 2021
- 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: Voluntary heathy adults
Who may be able to join
- Being between the ages of 18-30
- The absence of any medical diagnosis
- Having visual acurity or corrected visual acurity
- Being volunteer
Who cannot join
- The presence of any medical diagnosis
- The presence of any neurologic symptoms
- The presence of any sensory problems
- The presence of any balance problems
- The presence of any vestibular problems
- Previous ortophedic surgery
- The use of an additional assistive device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Visual Stimuli Provided by Virtual Reality on Postural Control in Healthy Subject
There are several studies examining the effects of different sensory stimuli on balance in healthy young people. Our study will especially explain how the same environment will affect postural control, when projected into VR environment. In this way, we aim to contribute to the literature and virtual reality programs used in rehabilitation.
Read the detailed description
Thanks to the development of technology in recent years, virtual reality applications have started to be included in physiotherapy. Virtual reality is used in both clinical and academic studies for the purpose of training rather than evaluation. In the literature, it has been emphasized that traditional balance training does not have any superiority over virtual reality and virtual reality training can be used as a practical alternative in the long term (12,13). Furthermore, the feedback provided by virtual reality games is effective in the patient\'s participation in the treatment. Different visual stimuli created using virtual reality can affect postural control in different ways (14). In addition, there is no study comparing the effect of real image and virtual reality image on postural control by transferring the current environment to virtual reality. The aim of this study is to reflect the real environment to virtual reality; To explain how postural control is affected by eyes closed, eyes open and in virtual reality. Two hypotheses were determined in this study.
H0: There is no significant difference between the real environment and three virtual environment on postural control in healhty subject.
H1: There is a significant difference between the real environment and three virtual environment on postural control in healthy subject.
- Conditions
- Healthy
- Being tested
- Assessment
- Keywords
- balance, postural control, virtual reality, visual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
No intervention will be applied to the participants. Postural stability will be evaluated in the virtual reality environment and real environment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sway Velocity
the average displacement of CoP per second
Measured: April 2021 - May 2021
Sway area
total area obtained by the displacement of the COP
Measured: April 2021 - May 2021
Perimeter
the total displacement of CoP
Measured: April 2021 - May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Apr 2021
- Primary completion30 Apr 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahra Şirvan Can, Master's, Principal investigator, Yeditepe UniversityÇiğdem v, PhD, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139900
- Sponsor's protocol ID
- 202106077
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asslander L, Streuber S. Virtual reality as a tool for balance research: Eyes open body sway is reproduced in photo-realistic, but not in abstract virtual scenes. PLoS One. 2020 Oct 29;15(10):e0241479. doi: 10.1371/journal.pone.0241479. eCollection 2020.
PubMed 33119679Chander H, Kodithuwakku Arachchige SNK, Hill CM, Turner AJ, Deb S, Shojaei A, Hudson C, Knight AC, Carruth DW. Virtual-Reality-Induced Visual Perturbations Impact Postural Control System Behavior. Behav Sci (Basel). 2019 Nov 12;9(11):113. doi: 10.3390/bs9110113.
PubMed 31718105
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Visual Stimuli Provided by Virtual Reality on Postural Control in Healthy Subject
- ClinicalTrials.gov ID
- NCT06139900
- Acronym / sponsor ID
- 202106077
- Conditions
- Healthy
- Keywords
- balance, postural control, virtual reality, visual
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 18 Nov 2023 (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.
There are several studies examining the effects of different sensory stimuli on balance in healthy young people. Our study will especially explain how the same environment will affect postural control, when projected into VR environment. In this way, we aim to contribute to the literature and virtual reality programs used in rehabilitation.
Detailed description
Thanks to the development of technology in recent years, virtual reality applications have started to be included in physiotherapy. Virtual reality is used in both clinical and academic studies for the purpose of training rather than evaluation. In the literature, it has been emphasized that traditional balance training does not have any superiority over virtual reality and virtual reality training can be used as a practical alternative in the long term (12,13). Furthermore, the feedback provided by virtual reality games is effective in the patient\'s participation in the treatment. Different visual stimuli created using virtual reality can affect postural control in different ways (14). In addition, there is no study comparing the effect of real image and virtual reality image on postural control by transferring the current environment to virtual reality. The aim of this study is to reflect the real environment to virtual reality; To explain how postural control is affected by eyes closed, eyes open and in virtual reality. Two hypotheses were determined in this study.
H0: There is no significant difference between the real environment and three virtual environment on postural control in healhty subject.
H1: There is a significant difference between the real environment and three virtual environment on postural control in healthy subject.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Voluntary heathy adults
Key inclusion criteria (4 listed)
- Being between the ages of 18-30
- The absence of any medical diagnosis
- Having visual acurity or corrected visual acurity
- Being volunteer
Key exclusion criteria (7 listed)
- The presence of any medical diagnosis
- The presence of any neurologic symptoms
- The presence of any sensory problems
- The presence of any balance problems
- The presence of any vestibular problems
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 |
|---|---|---|
| AssessmentNo intervention will be applied to the participants. Postural stability will be evaluated in the virtual reality environment and real environment. | Other | – |
Primary outcome
Sway Velocity
Time frame: April 2021 - May 2021
the average displacement of CoP per second
Sway area
Time frame: April 2021 - May 2021
total area obtained by the displacement of the COP
Perimeter
Time frame: April 2021 - May 2021
the total displacement of CoP
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 Dec 2023.
- Results publication: PubMed 33119679Asslander L, Streuber S. Virtual reality as a tool for balance research: Eyes open body sway is reproduced in photo-realistic, but not in abstract virtual scenes. PLoS One. 2020 Oct 29;15(10):e0241479. doi: 10.1371/journal.pone.0241479. eCollection 2020.
- Results publication: PubMed 31718105Chander H, Kodithuwakku Arachchige SNK, Hill CM, Turner AJ, Deb S, Shojaei A, Hudson C, Knight AC, Carruth DW. Virtual-Reality-Induced Visual Perturbations Impact Postural Control System Behavior. Behav Sci (Basel). 2019 Nov 12;9(11):113. doi: 10.3390/bs9110113.
- 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.
Sahra Şirvan Can, Master's principal investigator
Yeditepe University
Çiğdem v, PhD principal investigator
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 Healthy, 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 4 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 29 Dec 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?
Sway Velocity (time frame: April 2021 - May 2021). The study lists 3 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 NCT06139900, which also lists 2 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 Dec 2023.