search
Back to results

Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

Primary Purpose

Concussion, Mild, Sport Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Sensorimotor Training
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Concussion, Mild focused on measuring Concussion, Injury prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Training (Experimental)

No Virtual Reality Training (Control)

Arm Description

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.

True control.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 23, 2019
Last Updated
March 23, 2020
Sponsor
University of Mississippi Medical Center
Collaborators
University of West Alabama, Mississippi College
search

1. Study Identification

Unique Protocol Identification Number
NCT04036916
Brief Title
Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II
Official Title
Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
University of West Alabama, Mississippi College

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Sport Injury
Keywords
Concussion, Injury prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Training (Experimental)
Arm Type
Experimental
Arm Description
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.
Arm Title
No Virtual Reality Training (Control)
Arm Type
No Intervention
Arm Description
True control.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Sensorimotor Training
Other Intervention Name(s)
Cervical strength training
Intervention Description
Games/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck
Primary Outcome Measure Information:
Title
Injury incidence rate
Description
Traumatic injuries (concussion and leg injuries) across the 2019 soccer season/ number of countable athletic exposures
Time Frame
approximately 16 weeks
Title
Game Performance
Description
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.
Time Frame
approximately 16 weeks
Title
Standing Balance
Description
Standing balance (as measured on the Sway balance app 0 - 100 scale)
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Reaction Time
Description
Reaction time (as measured on the Sway balance app) including impulse control; inspection time; and simple reaction time
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Oculomotor Control
Description
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)
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Near-Point Convergence
Description
Distance of point of near-binocular convergence (as measured in centimeters)
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Cranial Cervical Flexion Test
Description
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)
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Deep Neck Flexor Endurance Test
Description
Cranial Cervical flexion endurance (measured in seconds)
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Isometric Neck Strength
Description
Measured by a dynamometer in flexion, extension, rotation and side-bending, recorded as force produced in each direction
Time Frame
Pre to post-intervention (approximately 6 weeks)
Secondary Outcome Measure Information:
Title
Score on Smooth Pursuit VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Saccades VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Near Point Convergence VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Joint Position Error VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Cervical Neuromotor Control VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Postural Control (Balance) VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Cervical Posture VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Visual Figure VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)
Title
Score on Peripheral Vision VR Game
Description
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.
Time Frame
Pre to post-intervention (approximately 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer C Reneker, PT, PhD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I will have to obtain institutional approval prior to any data being shared externally. This has not been discussed.

Learn more about this trial

Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

We'll reach out to this number within 24 hrs