Virtual RealityNCT04179916
Evaluation of Physiological Reactions in Virtual Reality
A study testing stimulation in virtual reality in people with Virtual Reality, run by The Opole University of Technology at 3 sites in 2 countries.
Trial summary
The purpose of virtual medicine is to minimize direct contact and impact on human body during treatment. Taking into consideration the increasing accessibility of high quality electronic devices, their immense computing powers, and the continuously developing Internet infrastructure, the advancement in this area is… Read more about this study
- Who is it for?
- Ages 21 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- stimulation in virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Dec 2019to 17 Jan 2020
- 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 21 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Age: 21-25
Who cannot join
- diagnosed internal diseases
- diseases and injuries of the locomotor system impairing the function of transport, especially injuries of the upper limb
- claustrophobia
- eye disorders
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Poland2 sites
The Ministry of the Interior and Administration Hospital
Głuchołazy, 48-340
Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology
Opole, 45-758
About this study
Official title: Evaluation of the Physical Reaction in Immersive Virtual Reality
The purpose of virtual medicine is to minimize direct contact and impact on human body during treatment. Taking into consideration the increasing accessibility of high quality electronic devices, their immense computing powers, and the continuously developing Internet infrastructure, the advancement in this area is only a matter of time. The project aims to analyze physiological reactions to stimuli in virtual reality in order to select appropriate stimulations for a group of pulmonary and cardiac patients.
Read the detailed description
In recent years, the literature has shown the results of many studies undertaking the possibility of applying new technologies in rehabilitation as elements of optimization, including Virtual Reality (VR). VR can be based on computer programs that use a three-dimensional camera or sensors placed on the body to read the patient's movements and transfer them to the screen in a computer-created environment. For the most part, VR research has focused on analyzing the therapeutic potential of typical virtual games, which are not designed for clinical use, but for entertainment and relaxation.
Rehabilitation in virtual reality has also become one of the common challenges for physiotherapists and IT specialists, who develop improvement programs dedicated to various diseases and illnesses. Numerous publications are available in the scientific literature, describing the possibilities of using VR as a diagnostic and therapeutic tool. The possibility of diagnostic application of the technology in motion analysis has been demonstrated. The use of VR in the analysis of respiratory mechanics and training of pulmonary patients has also been noted. Most of the available studies concern the rehabilitation of neurological patients. There are many studies available, including meta-analyses, which confirm that the best results of rehabilitation can be achieved through the use of traditional neurological rehabilitation combined with rehabilitation conducted in virtual reality. Only few papers describe physiological reactions, including heart rate variability (HRV) and thermovision diagnostics during stimulation in immersive virtual reality.
The aim of the study is to evaluate the physiological reactions of the organism in healthy subjects during stimulation in immersive virtual reality.
This study is focused on:
Monitoring physiological parameters including heart rate variability (HRV) and thermal imaging (TI) change in healthy subjects during stimulation in immersive virtual reality.
The result of proposed research may be the answer to the following questions:
- What changes in heart rate variability occur during the stimulation of various types of stimuli in virtual reality?
- Which alterations in body temperature, especially in the distal parts of the upper limb, occur during stimulation in virtual reality?
The evaluation session will be conduced in the following scheme in static seated position:
- Preparation of the research equipment
- Measurement without stimulation in virtual reality: HRV, TI - 6 minute
- Measurement in virtual reality: HRV, TI - simulation of cold environment (snow, wind) - 6 minute
- Measurement in virtual reality: HRV, TI - simulation of warm environment (the beach, the sea) - 6 minute
- Measurement in virtual reality: HRV, TI - simulation of terrifying environment (a dark room, ghosts) - 6 minute
- Measurement without stimulation in virulent reality: HRV, TI - 6 minute
- Completion of the measurements
- Conditions
- Virtual Reality
- Being tested
- stimulation in virtual reality
- Keywords
- virtual reality, VR, HRV, thermal imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulation in virtual realityDiagnostic test
HTC VIVE pro was used to stimulate patients in virtual reality. The glasses enable high resolution and high fluidity (90Hz) images to be displayed. The display used inside the glasses, OLED class, allows for accurate color replication. Numerous sensors placed in the glasses (such as gyroscope, accelerometer, magnetometer) supported by dedicated processors processing data from the sensors, instantly transfer the movement of the head of the rehabilitated person to virtual reality. Such a set allows to achieve full immersion in the virtual world. Various scenarios will be presented during the stimulation, such as beach, snow landscape, darkened room, rollercoaster ride.
It was planned to submit 3 scenarios with a total stimulation time of up to 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Participants between 21 and 25 years, the Faculty of Physical Education and Physiotherapy of the Opole University of Technology Students Receives: Diagnostic Test: stimulation in virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal Imaging
The thermographic camera Flir 435-0006-03 will be used for measurements. The forearm and hand area will be observed. Photographs will be taken with a sequence of 30 seconds.
Measured: 30 minutes
Secondary outcomes (1)
Heart Rate Variability
Throughout the examination, heart rate will be monitored by the Polar H10 optical heart rate sensor. Polar H10 is a monitor armband that combines versatility, comfort and simplicity.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start10 Dec 2019
- Primary completion13 Jan 2020
- Study completion17 Jan 2020
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.
- 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
- Model description
- For this study it was assumed to expose healthy volunteers for stimuli in the immersive virtual reality
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Camillo, Venezia, Italy
- Responsible party
- Principal investigator, Sebastian Rutkowski, The Opole University of Technology
- Investigators
- Sebastian Rutkowski, PhD, Principal investigator, The Opole University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179916
- Sponsor's protocol ID
- OpoleUofTech
- Status last verified
- Jun 2020
- First submitted
- 19 Nov 2019
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It was decided to provide free access to the analysed data. The data will be available upon request sent to PI: s.rutkowski@po.opole.pl.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Physical Reaction in Immersive Virtual Reality
- ClinicalTrials.gov ID
- NCT04179916
- Acronym / sponsor ID
- OpoleUofTech
- Conditions
- Virtual Reality
- Keywords
- virtual reality, VR, HRV, thermal imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Collaborators
- IRCCS San Camillo, Venezia, Italy
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 27 Nov 2019 (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 purpose of virtual medicine is to minimize direct contact and impact on human body during treatment. Taking into consideration the increasing accessibility of high quality electronic devices, their immense computing powers, and the continuously developing Internet infrastructure, the advancement in this area is only a matter of time. The project aims to analyze physiological reactions to stimuli in virtual reality in order to select appropriate stimulations for a group of pulmonary and cardiac patients.
Detailed description
In recent years, the literature has shown the results of many studies undertaking the possibility of applying new technologies in rehabilitation as elements of optimization, including Virtual Reality (VR). VR can be based on computer programs that use a three-dimensional camera or sensors placed on the body to read the patient's movements and transfer them to the screen in a computer-created environment. For the most part, VR research has focused on analyzing the therapeutic potential of typical virtual games, which are not designed for clinical use, but for entertainment and relaxation.
Rehabilitation in virtual reality has also become one of the common challenges for physiotherapists and IT specialists, who develop improvement programs dedicated to various diseases and illnesses. Numerous publications are available in the scientific literature, describing the possibilities of using VR as a diagnostic and therapeutic tool. The possibility of diagnostic application of the technology in motion analysis has been demonstrated. The use of VR in the analysis of respiratory mechanics and training of pulmonary patients has also been noted. Most of the available studies concern the rehabilitation of neurological patients. There are many studies available, including meta-analyses, which confirm that the best results of rehabilitation can be achieved through the use of traditional neurological rehabilitation combined with rehabilitation conducted in virtual reality. Only few papers describe physiological reactions, including heart rate variability (HRV) and thermovision diagnostics during stimulation in immersive virtual reality.
The aim of the study is to evaluate the physiological reactions of the organism in healthy subjects during stimulation in immersive virtual reality.
This study is focused on:
Monitoring physiological parameters including heart rate variability (HRV) and thermal imaging (TI) change in healthy subjects during stimulation in immersive virtual reality.
The result of proposed research may be the answer to the following questions:
- What changes in heart rate variability occur during the stimulation of various types of stimuli in virtual reality?
- Which alterations in body temperature, especially in the distal parts of the upper limb, occur during stimulation in virtual reality?
The evaluation session will be conduced in the following scheme in static seated position:
- Preparation of the research equipment
- Measurement without stimulation in virtual reality: HRV, TI - 6 minute
- Measurement in virtual reality: HRV, TI - simulation of cold environment (snow, wind) - 6 minute
- Measurement in virtual reality: HRV, TI - simulation of warm environment (the beach, the sea) - 6 minute
- Measurement in virtual reality: HRV, TI - simulation of terrifying environment (a dark room, ghosts) - 6 minute
- Measurement without stimulation in virulent reality: HRV, TI - 6 minute
- Completion of the measurements
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For this study it was assumed to expose healthy volunteers for stimuli in the immersive virtual reality
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Diagnostic Test: stimulation in virtual realityParticipants between 21 and 25 years, the Faculty of Physical Education and Physiotherapy of the Opole University of Technology Students |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Age: 21-25
Key exclusion criteria (4 listed)
- diagnosed internal diseases
- diseases and injuries of the locomotor system impairing the function of transport, especially injuries of the upper limb
- claustrophobia
- eye disorders
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 |
|---|---|---|
| stimulation in virtual realityHTC VIVE pro was used to stimulate patients in virtual reality. The glasses enable high resolution and high fluidity (90Hz) images to be displayed. The display used inside the glasses, OLED class, allows for accurate color replication. Numerous sensors placed in the glasses (such as gyroscope, accelerometer, magnetometer) supported by dedicated processors processing data from the sensors, instantly transfer the movement of the head of the rehabilitated person to virtual reality. Such a set allows to achieve full immersion in the virtual world. Various scenarios will be presented during the stimulation, such as beach, snow landscape, darkened room, rollercoaster ride. It was planned to submit 3 scenarios with a total stimulation time of up to 20 minutes. | Diagnostic test | Healthy volunteers |
Primary outcome
Thermal Imaging
Time frame: 30 minutes
The thermographic camera Flir 435-0006-03 will be used for measurements. The forearm and hand area will be observed. Photographs will be taken with a sequence of 30 seconds.
1 secondary outcome
Heart Rate Variability
Time frame: 30 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 22 Jun 2020.
- Individual participant dataSharing planned: Yes. It was decided to provide free access to the analysed data. The data will be available upon request sent to PI: s.rutkowski@po.opole.pl.
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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.
Sebastian Rutkowski, PhD principal investigator
The Opole University of Technology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stimulation in virtual reality in people with Virtual Reality, run by The Opole University of Technology at 3 sites in 2 countries.
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 1 inclusion and 4 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Italy. 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?
Thermal Imaging (time frame: 30 minutes). 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 22 Jun 2020.