Dynamic Vision Testing and Concussion Management

Recruiting

• Conditions: Head Injury; Concussion, Brain; Sport Injury

• Registration Number: NCT04837066
• Lead Sponsor: California State University, Northridge

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."

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Study Start: 2021-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamic Visual Acuity (DVA)	August 15, 2021 - August 15, 2024	Log of minimal angle resolvable units (LogMAR). The number of lines on an eye chart that are lost with head moving (DVA) compared to the head steady condition, known as static visual acuity (SVA)
6-Condition BESS	August 15, 2021 - August 15, 2024	Number of errors and time subject was able to hold position
Gaze Stabilization Test (GST)	August 15, 2021 - August 15, 2024	Maximum head velocity in degrees/second

Trial Locations

Locations (1)

California State University, Northridge, Jacaranda Hall 1578, 1576, 1574; 🇺🇸 Northridge, California, United States