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Fuzzy AI Using VR for Collision Prevention (CAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915119
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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, during a single training session and also when assessed at approximately 1 week and 1 month following training.

Condition or disease Intervention/treatment Phase
Injuries Other: GFT AI training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Genetic Fuzzy Artificial Intelligence Driven Virtual Reality for Prevention of Collision-based Injury
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: VR Obstacle group

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):

Other: GFT AI training
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

Experimental: Agility Group

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

Other: GFT AI training
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Self paced saccades [ Time Frame: 10 minutes ]
    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.

  2. Anti-saccades test [ Time Frame: 10 minutes ]
    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.



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Ages Eligible for Study:   14 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • varsity high school or collegiate soccer athlete

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915119


Locations
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United States, Ohio
Cincinanti Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Adam Kiefer, PhD Cincinanti Childrens Hospital
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03915119    
Other Study ID Numbers: 2017-6006
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries