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.

Study Overview

• Status: Completed
• Conditions: Sport Injury; Concussion, Mild
• Intervention / Treatment: Other: Virtual Reality Sensorimotor Training

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Training (Experimental); Participants will receive multi-modal sensorimotor training interventions, including activities training the vestibular system, oculomotor control and visual perception, neuromotor control and strengthening of the cervical spine, postural control/ balance exercises, and exercises integrating the use of multiple types of sensory information for controlled motor output, including speed and accuracy. Novel headset virtual reality (VR) games/activities; compliant balance surfaces; resistance bands/weight; and biofeedback devices will be utilized to deliver the training intervention. The exercises delivered at each intervention will be delivered in a group format, using a circuit of exercises that each athlete will complete in a session. Subsequent sessions will build upon previous sessions to work the sensorimotor control system in progressively more challenging and sport-specific scenarios. This present study will complete 12 sessions over 6 weeks.	Other: Virtual Reality Sensorimotor Training; Games/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck; Other Names: Cervical strength training
No Intervention: No Virtual Reality Training (Control); True control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injury incidence rate	Traumatic injuries (concussion and leg injuries) across the 2019 soccer season/ number of countable athletic exposures	approximately 16 weeks
Game Performance	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.	approximately 16 weeks
Standing Balance	Standing balance (as measured on the Sway balance app 0 - 100 scale)	Pre to post-intervention (approximately 6 weeks)
Reaction Time	Reaction time (as measured on the Sway balance app) including impulse control; inspection time; and simple reaction time	Pre to post-intervention (approximately 6 weeks)
Oculomotor Control	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)	Pre to post-intervention (approximately 6 weeks)
Near-Point Convergence	Distance of point of near-binocular convergence (as measured in centimeters)	Pre to post-intervention (approximately 6 weeks)
Cranial Cervical Flexion Test	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)	Pre to post-intervention (approximately 6 weeks)
Deep Neck Flexor Endurance Test	Cranial Cervical flexion endurance (measured in seconds)	Pre to post-intervention (approximately 6 weeks)
Isometric Neck Strength	Measured by a dynamometer in flexion, extension, rotation and side-bending, recorded as force produced in each direction	Pre to post-intervention (approximately 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Smooth Pursuit VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Saccades VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Near Point Convergence VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Joint Position Error VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Cervical Neuromotor Control VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Postural Control (Balance) VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Cervical Posture VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Visual Figure VR Game	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.	Pre to post-intervention (approximately 6 weeks)
Score on Peripheral Vision VR Game	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.	Pre to post-intervention (approximately 6 weeks)

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: University of West Alabama; Mississippi College
• Investigators: Principal Investigator: Jennifer C Reneker, PT, PhD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Concussion; Injury prevention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Athletic Injuries; Brain Concussion
• Other Study ID Numbers: 2019-0157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I will have to obtain institutional approval prior to any data being shared externally. This has not been discussed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No