Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

Study Overview
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Brief Summary
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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.

Official Title
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Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

Conditions
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Concussion, Mild, Sport Injury

Intervention / Treatment
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* Other: Virtual Reality Sensorimotor Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Training (Experimental)<br>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<br>* Games/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck<br>* Other names: Cervical strength training;|
| No Intervention: No Virtual Reality Training (Control)<br>True control. | |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, Injury prevention