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Completed

NCT Number: NCT04036916

Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

The purpose of this project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve, injury incidence rate will decrease and on-field soccer performance will improve.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female athletes
  • 18 years of age or older
  • on the soccer roster who are eligible to play in the fall 2019 season at the participating institutions.

Exclusion criteria

  • Current diagnosis of concussion (i.e. a non-medically cleared concussion)
  • Current lower-extremity musculoskeletal injury,
  • Seizure disorder with photo sensitivity
  • Other medical diagnosis that will prevent participation in the intervention.

Treatment and study plan

Virtual Reality Sensorimotor Training

Other

Games/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck

Other names: Cervical strength training

Primary outcomes

  1. Injury incidence rate

    Time frame: approximately 16 weeks

    Traumatic injuries (concussion and leg injuries) across the 2019 soccer season/ number of countable athletic exposures

  2. Game Performance

    Time frame: approximately 16 weeks

    Game performance will be analyzed through video recording of the 2019 season's games and analysis of performance metrics (performed by InStat). Key performance indices (with higher scores reflecting better performance during game play) will be used as the metric of game performance.

  3. Standing Balance

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Standing balance (as measured on the Sway balance app 0 - 100 scale)

  4. Reaction Time

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Reaction time (as measured on the Sway balance app) including impulse control; inspection time; and simple reaction time

  5. Oculomotor Control

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Accuracy and latency of saccadic eye movements and smooth pursuit eye movements in response to an object presented to the participant on a computer screen (as measured by the Tobii eye tracker)

  6. Near-Point Convergence

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Distance of point of near-binocular convergence (as measured in centimeters)

  7. Cranial Cervical Flexion Test

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Cranial-cervical flexion neuromotor control (as measured by performance on the Cranial Cervical Flexion Test, mmHg level of control with a 3 second hold on a biofeedback pressure cuff)

  8. Deep Neck Flexor Endurance Test

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Cranial Cervical flexion endurance (measured in seconds)

  9. Isometric Neck Strength

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Measured by a dynamometer in flexion, extension, rotation and side-bending, recorded as force produced in each direction

Secondary outcomes

  1. Score on Smooth Pursuit VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to follow a moving object with eyes while tracing manually. Accuracy of manual trace produces total score. Higher score = better performance.

  2. Score on Saccades VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to shift eyes to location of a presented visual stimulus and to activate the location with a manual control. Speed and accuracy of manual activation produces total score. Higher score = better performance.

  3. Score on Near Point Convergence VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to follow a moving object with eyes while tracing manually. Accuracy of manual trace produces total score. Higher score = better performance.

  4. Score on Joint Position Error VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity which is conducted according to the Clinical Joint Position Error Test. Accuracy of head relocation after 3 movements to the left, 3 to the right and 3 into extension produces total score. Higher score = better performance.

  5. Score on Cervical Neuromotor Control VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to use head and neck movement control to trace a maze. Score is based on accuracy and speed of maze trace.

    Higher score = better performance.

  6. Score on Postural Control (Balance) VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to maintain standing balance while visual scene in VR is tilting left and right. Score is based on postural sway as recorded by headset sensors. Higher score = better performance.

  7. Score on Cervical Posture VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity. Requires participant to reproduce a chin-tucked position and hold for 5 seconds. Score is based on correct head alignment (as compared to starting position, measured by headset sensors) across 10 repetitions. Higher score = better performance.

  8. Score on Visual Figure VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to visually search a complex scene to find a hidden object. Score is based on the number of correct manual identifications of the hidden object. Higher score = better performance.

  9. Score on Peripheral Vision VR Game

    Time frame: Pre to post-intervention (approximately 6 weeks)

    Score on activities as recorded in headset VR. This game is scored on a 0 - 1000 point scale during completion of the game activity for 60 seconds. Requires participant to focus on central object and use peripheral vision to identify the same object and indicate with a manual selection. Score is based on number of correct identifications. Higher score = better performance.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • Mississippi College
  • University of West Alabama

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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