NCT04036916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

August 12, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

July 23, 2019

Last Update Submit

March 23, 2020

Conditions

Keywords

ConcussionInjury prevention

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (9)

  • Score on Smooth Pursuit VR Game

    Pre to post-intervention (approximately 6 weeks)

  • Score on Saccades VR Game

    Pre to post-intervention (approximately 6 weeks)

  • Score on Near Point Convergence VR Game

    Pre to post-intervention (approximately 6 weeks)

  • Score on Joint Position Error VR Game

    Pre to post-intervention (approximately 6 weeks)

  • Score on Cervical Neuromotor Control VR Game

    Pre to post-intervention (approximately 6 weeks)

  • +4 more secondary outcomes

Study Arms (2)

Virtual Reality Training (Experimental)

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

No Virtual Reality Training (Control)

NO INTERVENTION

True control.

Interventions

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

Also known as: Cervical strength training
Virtual Reality Training (Experimental)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Jennifer C Reneker, PT, PhD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 30, 2019

Study Start

August 12, 2019

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

I will have to obtain institutional approval prior to any data being shared externally. This has not been discussed.

Locations