Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

March 23, 2020 updated by: Jennifer C. Reneker, University of Mississippi Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Injury incidence rate
Time Frame: approximately 16 weeks
Traumatic injuries (concussion and leg injuries) across the 2019 soccer season/ number of countable athletic exposures
approximately 16 weeks
Game Performance
Time Frame: approximately 16 weeks
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
Standing balance (as measured on the Sway balance app 0 - 100 scale)
Pre to post-intervention (approximately 6 weeks)
Reaction Time
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
Distance of point of near-binocular convergence (as measured in centimeters)
Pre to post-intervention (approximately 6 weeks)
Cranial Cervical Flexion Test
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
Cranial Cervical flexion endurance (measured in seconds)
Pre to post-intervention (approximately 6 weeks)
Isometric Neck Strength
Time Frame: Pre to post-intervention (approximately 6 weeks)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Score on Smooth Pursuit VR Game
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)

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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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
Time Frame: Pre to post-intervention (approximately 6 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Mississippi Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of West Alabama
Mississippi College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer C Reneker, PT, PhD, University of Mississippi Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings