Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

Concussion, Mild Clinical Trial

Official title:

Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036916
• Other study ID #: 2019-0157
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: March 2020
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Concussion, Mild
• Sport Injury
• Wounds and Injuries

Intervention

Other:
• Virtual Reality Sensorimotor Training
Games/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Mississippi College, University of West Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injury incidence rate	Traumatic injuries (concussion and leg injuries) across the 2019 soccer season/ number of countable athletic exposures	approximately 16 weeks
Primary	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
Primary	Standing Balance	Standing balance (as measured on the Sway balance app 0 - 100 scale)	Pre to post-intervention (approximately 6 weeks)
Primary	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)
Primary	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)
Primary	Near-Point Convergence	Distance of point of near-binocular convergence (as measured in centimeters)	Pre to post-intervention (approximately 6 weeks)
Primary	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)
Primary	Deep Neck Flexor Endurance Test	Cranial Cervical flexion endurance (measured in seconds)	Pre to post-intervention (approximately 6 weeks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)