InjuriesCATNCT03915119
Fuzzy AI Using VR for Collision Prevention
A study testing GFT AI training in people with Injuries, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a VR training system that integrates GFT AI with virtual obstacle scenarios that, when compared to a sham-VR training system, is hypothesized to increase neuromechanical and perceptual-motor fitness, decrease collision frequency and impact forces for soccer athletes… Read more about this study
- Who is it for?
- Ages 14 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries
- What is being tested?
- GFT AI training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 30 Sep 2019
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy
- varsity high school or collegiate soccer athlete
Who cannot join
- unable to participate in soccer
- history of congenital or acquired cognitive, ophthalmologic, or neurological disorders including developmental delay, brain tumor, stroke, or known peripheral or central vestibular disorders
- patients who have begun anti-depressant, stimulant or anti-seizure medications for treatment of their symptoms or for other, unrelated reasons within two months of testing will be excluded from testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Genetic Fuzzy Artificial Intelligence Driven Virtual Reality for Prevention of Collision-based Injury
The purpose of this study is to develop and test a VR training system that integrates GFT AI with virtual obstacle scenarios that, when compared to a sham-VR training system, is hypothesized to increase neuromechanical and perceptual-motor fitness, decrease collision frequency and impact forces for soccer athletes, during a single training session and also when assessed at approximately 1 week and 1 month following training.
Read the detailed description
Player collisions cause over 70% of concussion injuries in contact sports, in addition to 50% of lower extremity injuries and 40% of catastrophic knee ligament injuries. The majority of these collisions are unanticipated, and associated with reduced neuromechanical and perceptual-motor fitness underlying an athlete's adaptability to on-field conditions. Thus, training collision anticipation necessitates a method that taps into neuromechanical and perceptual-motor fitness. Virtual reality (VR) is a tool that can target these mechanisms, while providing a safe, well-controlled environment for assessment and training. The current proposal innovates on VR with the integration of genetic fuzzy tree (GFT) artificial intelligence (AI) to drive scenario configuration designed to target modifiable mechanisms and tailored to the individual athlete's performance capabilities, for the optimization of behavior modification and skill transfer. The current study will examine test a GFT AI-driven VR collision anticipation training compared to a sham-VR training system in healthy soccer athletes.
- Conditions
- Injuries
- Being tested
- GFT AI training
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFT AI trainingOther
navigates a cluttered environment of stationary and moving/pursuing virtual obstacles to reach a way-point as quickly and efficiently as possible. Block order and difficulty, as well as the behavior of the obstacles in each block, will be driven by the AI and statistically weighted to specifically target the perceptual-motor and neuromechanical mechanisms based on each athlete's visit 1 performance
| Study group | Role | What they receive |
|---|---|---|
| VR Obstacle group | Experimental | Initial Visit: navigates a cluttered array of fixed and moving virtual obstacles to reach a way-point (goal) as fast and efficiently (avoiding obstacles) as possible. In each block, task difficulty (i.e., complexity) will increase linearly, regardless of success or failure (≥ 1 collision before reaching the goal).
Second (Training) Visit (randomized into two groups): Receives: Other: GFT AI training |
| Agility Group | Experimental | Initial Visit: Completes a soccer ball dribbling agility task in which they must dribble a soccer ball toward an artificial way-point, while avoiding artificial obstacles overlaid onto the real world via a Microsoft Hololens augmented reality display.
Second (Training) Visit Receives: Other: GFT AI training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-saccades test
Pro-saccades will be tested as participants track discrete target motion that will jump randomly by 14, 16, 18, 20, 22, or 24˚ on the screen in a horizontal and vertical direction, at intervals varying pseudo randomly between 1.0 and 2.0 s. The current fixation target will be extinguished at the same time as the next peripheral target appears. The test sequence will take 30 s/trial (2 trials) and all participants will be instructed to follow the targets as quickly and accurately as possible
Measured: 10 minutes
Secondary outcomes (2)
Self paced saccades
Self-paced saccades will be assessed as the participant glances back and forth as quickly and accurately as possible between two constantly visual targets at ± 15˚ horizontally from one another. This test will take 30 s per trial and the participant will perform 2 trials.
Measured: 10 minutes
Anti-saccades test
Anti-saccades will be tested as participants are presented discrete targets that jump randomly by 14, 16, 18, 20, 22, or 24˚ on the screen in a horizontal and vertical direction, at intervals varying pseudo randomly between 1.0 and 2.0 s while a cross-hairs is present in the center of the screen. The athletes will be instructed to fixate on the cross-hairs and at the moment each object appears, to saccade in the opposite direction and then return their gaze back to the cross-hairs for the start of the next trial.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jan 2018
- Primary completion1 Feb 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Kiefer, PhD, Principal investigator, Cincinanti Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915119
- Sponsor's protocol ID
- 2017-6006
- Acronym
- CAT
- Status last verified
- Feb 2020
- First submitted
- 30 Oct 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Fuzzy Artificial Intelligence Driven Virtual Reality for Prevention of Collision-based Injury
- ClinicalTrials.gov ID
- NCT03915119
- Acronym / sponsor ID
- CAT / 2017-6006
- Conditions
- Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 16 Apr 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 this study is to develop and test a VR training system that integrates GFT AI with virtual obstacle scenarios that, when compared to a sham-VR training system, is hypothesized to increase neuromechanical and perceptual-motor fitness, decrease collision frequency and impact forces for soccer athletes, during a single training session and also when assessed at approximately 1 week and 1 month following training.
Detailed description
Player collisions cause over 70% of concussion injuries in contact sports, in addition to 50% of lower extremity injuries and 40% of catastrophic knee ligament injuries. The majority of these collisions are unanticipated, and associated with reduced neuromechanical and perceptual-motor fitness underlying an athlete's adaptability to on-field conditions. Thus, training collision anticipation necessitates a method that taps into neuromechanical and perceptual-motor fitness. Virtual reality (VR) is a tool that can target these mechanisms, while providing a safe, well-controlled environment for assessment and training. The current proposal innovates on VR with the integration of genetic fuzzy tree (GFT) artificial intelligence (AI) to drive scenario configuration designed to target modifiable mechanisms and tailored to the individual athlete's performance capabilities, for the optimization of behavior modification and skill transfer. The current study will examine test a GFT AI-driven VR collision anticipation training compared to a sham-VR training system in healthy soccer athletes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Obstacle group | Experimental | Other: GFT AI trainingInitial Visit: navigates a cluttered array of fixed and moving virtual obstacles to reach a way-point (goal) as fast and efficiently (avoiding obstacles) as possible. In each block, task difficulty (i.e., complexity) will increase linearly, regardless of success or failure (≥ 1 collision before reaching the goal). Second (Training) Visit (randomized into two groups): |
| Agility Group | Experimental | Other: GFT AI trainingInitial Visit: Completes a soccer ball dribbling agility task in which they must dribble a soccer ball toward an artificial way-point, while avoiding artificial obstacles overlaid onto the real world via a Microsoft Hololens augmented reality display. Second (Training) Visit |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- healthy
- varsity high school or collegiate soccer athlete
Key exclusion criteria (3 listed)
- unable to participate in soccer
- history of congenital or acquired cognitive, ophthalmologic, or neurological disorders including developmental delay, brain tumor, stroke, or known peripheral or central vestibular disorders
- patients who have begun anti-depressant, stimulant or anti-seizure medications for treatment of their symptoms or for other, unrelated reasons within two months of testing will be excluded from testing
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 |
|---|---|---|
| GFT AI trainingnavigates a cluttered environment of stationary and moving/pursuing virtual obstacles to reach a way-point as quickly and efficiently as possible. Block order and difficulty, as well as the behavior of the obstacles in each block, will be driven by the AI and statistically weighted to specifically target the perceptual-motor and neuromechanical mechanisms based on each athlete's visit 1 performance | Other | Agility Group, VR Obstacle group |
Primary outcome
Pro-saccades test
Time frame: 10 minutes
Pro-saccades will be tested as participants track discrete target motion that will jump randomly by 14, 16, 18, 20, 22, or 24˚ on the screen in a horizontal and vertical direction, at intervals varying pseudo randomly between 1.0 and 2.0 s. The current fixation target will be extinguished at the same time as the next peripheral target appears. The test sequence will take 30 s/trial (2 trials) and all participants will be instructed to follow the targets as quickly and accurately as possible
2 secondary outcomes
Self paced saccades
Time frame: 10 minutes
Anti-saccades test
Time frame: 10 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 7 Feb 2020.
- 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.
Adam Kiefer, PhD principal investigator
Cincinanti Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GFT AI training in people with Injuries, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 3 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 7 Feb 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 United States. 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?
Pro-saccades test (time frame: 10 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 7 Feb 2020.