Clinical trial NCT04837066: Dynamic Vision Testing and Concussion Management
Official title: Dynamic Vision Testing and Concussion Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head Injury
Sport Injury
Concussion, Brain
Lead sponsor: California State University, Northridge
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Due to COVID-19 and the uncertainty of which teams will be competing during the academic year, our subject pool will potentially come from any athlete who provides consent from an equal number of men's and women's teams who are competing that semester.

Brief summary: The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

Detailed description: The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."

Eligibility criteria: Inclusion Criteria:

* California State University Northridge athletes
* Participants are able to give consent to participate in the study
* Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team
* Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
* Sampling of convenience on a volunteer basis

Exclusion Criteria:

* Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.
* The initial 6- condition BESS score is \>20 errors
* The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.

Primary outcomes:
measure: 6-Condition BESS
timeFrame: August 15, 2021 - August 15, 2024
measure: Gaze Stabilization Test (GST)
timeFrame: August 15, 2021 - August 15, 2024
measure: Dynamic Visual Acuity (DVA)
timeFrame: August 15, 2021 - August 15, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Northridge
country: United States
facility: California State University, Northridge, Jacaranda Hall 1578, 1576, 1574
state: California
Study officials:
affiliation: CSUN
name: Aimie Kachingwe, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: CSUN
name: Margaret Roller, Dr.
role: PRINCIPAL_INVESTIGATOR
References: