NCT03915119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

October 30, 2018

Last Update Submit

February 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    10 minutes

Secondary Outcomes (2)

  • Self paced saccades

    10 minutes

  • Anti-saccades test

    10 minutes

Study Arms (2)

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):

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

Other: GFT AI training

Interventions

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

Agility GroupVR Obstacle group

Eligibility Criteria

Age14 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy
  • varsity high school or collegiate soccer athlete

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinanti Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Adam Kiefer, PhD

    Cincinanti Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

April 16, 2019

Study Start

January 1, 2018

Primary Completion

February 1, 2019

Study Completion

September 30, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations