Virtual RealityNCT04662983
Effects of Immersive Virtual Reality Traning on an Eye-hand Coordination and Time Reaction
A study testing VR-training in people with Virtual Reality and Coordination Impairment, run by The Opole University of Technology at 1 site in Poland.
Trial summary
Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. In most educational communities VR has been used as an opportunity to support many students. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Coordination Impairment
- What is being tested?
- VR-training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePoland
- Study dates
- 23 Nov 2020to 16 Dec 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- acceptance to participate in the research,
- age 14-24
Who cannot join
- diagnosed neurological diseases,
- fear of restricted vision or putting on goggles,
- diagnosed musculoskeletal diseases,
- injuries to the musculoskeletal system,
- regular sports activities during the week.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Faculty of Physical Education and Physiotherapy, Opole University of Technology
Opole, 45-758
About this study
Official title: Evaluation of the Effects of Immersive Virtual Reality Training on an Eye-hand Coordination and Central Executive Functioning in Young Musicians
Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. In most educational communities VR has been used as an opportunity to support many students. VR allows the user to observe the world generated for their own needs as the real world and experience impressions that are not available in real life. It was decided to examine how immersive VR-game will affect the eye-hand coordination on music school students. The experimental group received a five-day training sessions using immersive VR game "Beat Saber", while control group was inactive comparator.
Read the detailed description
Eye-hand coordination can be defined as the ability to perform activities that require the simultaneous use of eyes and hands. Eye-hand coordination supports our daily activities, interactions with objects and people, and is critical to understanding how the brain creates internal models of the space and generates movement within it (2). The eye-hand coordination represents the integration of visual information, perceptual stimuli and motor decisions in order to perform a specific task. Along with the development of technology, opportunities for stimulation of eye-hand coordination with the use of technical novelties have appeared. Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. It has become one of the technologies that offer many possibilities of application and use of its various aspects that can bring great benefits in the real world. In most educational communities VR has been used as an opportunity to support many students. VR allows the user to observe the world generated for their own needs as the real world and experience impressions that are not available in real life. It can be assumed that VR can help trainers or teachers, especially music teachers, by interacting through movement, realization and graphic images, to develop and shape skills such as eye to hand coordination. The use of virtual reality gives a wide range of possibilities for training, so it was decided to examine how it will affect the coordination of the eye-hand response in music school students.
The aim of the research was to evaluate the eye-hand coordination of music school students undergoing training sessions in the musical game "Beat Saber" conducted in immersive virtual reality.
- Conditions
- Virtual Reality, Coordination Impairment
- Being tested
- VR-training
- Keywords
- virtual reality, VR, eye-hand coordination, exergame, energy expenditure
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-trainingDevice
A musical game called Beat Saber was used to conduct training sessions. The participant's task was to cut through the blocks of various colors in his direction to the rhythm of music, using two virtual swords. The swords were controlled by the player with controllers of different colors. Blocks had to be cut with a sword whose color matches the block and in the right direction which is indicated by an arrow on the block. The training session consisted of 4 music tracks with different pace and intensity of objects. In addition, during the song, the participant had to avoid objects-objects that randomly appeared in the game scenario - forcing the whole body to move.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The participants were subjected to a 15-minute training session, once a day for 5 consecutive days. HTC VIVE Pro (HTC Corporation, New Taipei, Taiwan) goggles and accessories were used. It is specialized equipment consisting of a high-resolution screen goggles and headphones, using an Intel WiGig Wireless connection, and the technology allows for free 360 degrees of movement. The interaction in virtual reality is performed using two controllers held by the player. The movement of the controllers and goggles is tracked by two sensors. The game area covered about 5m2, in the form of a rectangle, determined by the location of motion sensors, as recommended by the manufacturer. The participant received visual information when approaching the boundaries of the game field. A Beat Saber music game was used to conduct training sessions. Receives: Device: VR-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail Making Test
Trial Making Test (TMT) A and TMT B were used to assess coordination. This test is a clinical tool for assessing eye-hand coordination. The task of the person tested in the first part (TMT A) was to combine 25 fields in order from the smallest to the largest continuous line. In the second part (TMT B), the subject was to alternate the numbers with the letters of the alphabet according to the formula 1-A, 2-B, 3-C, etc. with a continuous line. The result of the test is the time when the tested person connected all fields in the right order.
Measured: up to 5 days
Plate Tapping Test
The Plate Tapping Test (Reaction Tap Test) is a reaction test using an alternating wall tapping action which measures upper body reaction time, hand-eye quickness and coordination. This test is part of the Eurofit Testing Battery.
Measured: up to 5 days
The ruler-drop test (Ditrich's test)
During the test, the tester sat on the chair face to face, on the with which he supported his forearm (in the middle of the length). The four fingers of the hand of the examined person were tight and the thumb was visited. The tester held a rod with a diameter of 1.5 cm and length of 50 cm, on which was marked with a centimeter scale. The task of the examined person was to react as quickly as possible to her movement and by clenching the hand grip sticks. The distance from the beginning was measured scale to the point of grasp (bottom edge hands).
Measured: up to 5 days
Secondary outcomes (1)
Energy expenditure
The SenseWear Armband was used to assess energy expenditure. The device was placed on the arm of the dominant upper limb. It continuously measured physiological variables through algorithms which determined the number of steps, MET, energy expenditure, and kcal
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start23 Nov 2020
- Primary completion11 Dec 2020
- Study completion16 Dec 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Rutkowski, PhD, Principal investigator, The Opole University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662983
- Sponsor's protocol ID
- OpoleUofTech3
- Status last verified
- Dec 2020
- First submitted
- 14 Nov 2020
- Last updated
- 17 Dec 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Immersive Virtual Reality Training on an Eye-hand Coordination and Central Executive Functioning in Young Musicians
- ClinicalTrials.gov ID
- NCT04662983
- Acronym / sponsor ID
- OpoleUofTech3
- Conditions
- Virtual Reality, Coordination Impairment
- Keywords
- virtual reality, VR, eye-hand coordination, exergame, energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 10 Dec 2020 (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 three-dimensional image, which is created by means of computer programs. In most educational communities VR has been used as an opportunity to support many students. VR allows the user to observe the world generated for their own needs as the real world and experience impressions that are not available in real life. It was decided to examine how immersive VR-game will affect the eye-hand coordination on music school students. The experimental group received a five-day training sessions using immersive VR game "Beat Saber", while control group was inactive comparator.
Detailed description
Eye-hand coordination can be defined as the ability to perform activities that require the simultaneous use of eyes and hands. Eye-hand coordination supports our daily activities, interactions with objects and people, and is critical to understanding how the brain creates internal models of the space and generates movement within it (2). The eye-hand coordination represents the integration of visual information, perceptual stimuli and motor decisions in order to perform a specific task. Along with the development of technology, opportunities for stimulation of eye-hand coordination with the use of technical novelties have appeared. Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. It has become one of the technologies that offer many possibilities of application and use of its various aspects that can bring great benefits in the real world. In most educational communities VR has been used as an opportunity to support many students. VR allows the user to observe the world generated for their own needs as the real world and experience impressions that are not available in real life. It can be assumed that VR can help trainers or teachers, especially music teachers, by interacting through movement, realization and graphic images, to develop and shape skills such as eye to hand coordination. The use of virtual reality gives a wide range of possibilities for training, so it was decided to examine how it will affect the coordination of the eye-hand response in music school students.
The aim of the research was to evaluate the eye-hand coordination of music school students undergoing training sessions in the musical game "Beat Saber" conducted in immersive virtual reality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: VR-trainingThe participants were subjected to a 15-minute training session, once a day for 5 consecutive days. HTC VIVE Pro (HTC Corporation, New Taipei, Taiwan) goggles and accessories were used. It is specialized equipment consisting of a high-resolution screen goggles and headphones, using an Intel WiGig Wireless connection, and the technology allows for free 360 degrees of movement. The interaction in virtual reality is performed using two controllers held by the player. The movement of the controllers and goggles is tracked by two sensors. The game area covered about 5m2, in the form of a rectangle, determined by the location of motion sensors, as recommended by the manufacturer. The participant received visual information when approaching the boundaries of the game field. A Beat Saber music game was used to conduct training sessions. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- acceptance to participate in the research,
- age 14-24
Key exclusion criteria (5 listed)
- diagnosed neurological diseases,
- fear of restricted vision or putting on goggles,
- diagnosed musculoskeletal diseases,
- injuries to the musculoskeletal system,
- regular sports activities during the week.
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 |
|---|---|---|
| VR-trainingA musical game called Beat Saber was used to conduct training sessions. The participant's task was to cut through the blocks of various colors in his direction to the rhythm of music, using two virtual swords. The swords were controlled by the player with controllers of different colors. Blocks had to be cut with a sword whose color matches the block and in the right direction which is indicated by an arrow on the block. The training session consisted of 4 music tracks with different pace and intensity of objects. In addition, during the song, the participant had to avoid objects-objects that randomly appeared in the game scenario - forcing the whole body to move. | Device | Experimental group |
Primary outcome
Trail Making Test
Time frame: up to 5 days
Trial Making Test (TMT) A and TMT B were used to assess coordination. This test is a clinical tool for assessing eye-hand coordination. The task of the person tested in the first part (TMT A) was to combine 25 fields in order from the smallest to the largest continuous line. In the second part (TMT B), the subject was to alternate the numbers with the letters of the alphabet according to the formula 1-A, 2-B, 3-C, etc. with a continuous line. The result of the test is the time when the tested person connected all fields in the right order.
Plate Tapping Test
Time frame: up to 5 days
The Plate Tapping Test (Reaction Tap Test) is a reaction test using an alternating wall tapping action which measures upper body reaction time, hand-eye quickness and coordination. This test is part of the Eurofit Testing Battery.
The ruler-drop test (Ditrich's test)
Time frame: up to 5 days
During the test, the tester sat on the chair face to face, on the with which he supported his forearm (in the middle of the length). The four fingers of the hand of the examined person were tight and the thumb was visited. The tester held a rod with a diameter of 1.5 cm and length of 50 cm, on which was marked with a centimeter scale. The task of the examined person was to react as quickly as possible to her movement and by clenching the hand grip sticks. The distance from the beginning was measured scale to the point of grasp (bottom edge hands).
1 secondary outcome
Energy expenditure
Time frame: up to 5 days
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 17 Dec 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-training in people with Virtual Reality and Coordination Impairment, run by The Opole University of Technology at 1 site in Poland.
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 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 17 Dec 2020. 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 Poland. 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?
Trail Making Test (time frame: up to 5 days). 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?
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 17 Dec 2020.