- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04837066
Dynamic Vision Testing and Concussion Management
July 8, 2026 updated by: Aimie Kachingwe, California State University, Northridge
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
100
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
-
-
California
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Northridge, California, United States, 91330-8411
- California State University, Northridge, Jacaranda Hall 1578, 1576, 1574
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-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
D1 athlete who is currently an enrolled student, actively competing in specific sport, provides consent to participate, and able to complete the testing protocol.
Description
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
- 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 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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Student Athletes
D1 student athletes currently enrolled in a large public university in the Los Angeles area and competing in one of the following sports: men's and women's soccer, men's and women's basketball, women's water polo and men's volleyball.
|
Assessment tool and computerized tests designed to evaluate postural stability and vestibulo-ocular reflex (VOR) function while assisting with return to play decision after a sports-related concussion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Condition BESS
Time Frame: August 15, 2021 - August 15, 2024
|
Number of errors and time subject was able to hold position
|
August 15, 2021 - August 15, 2024
|
|
Gaze Stabilization Test (GST)
Time Frame: August 15, 2021 - August 15, 2024
|
Maximum head velocity in degrees/second
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August 15, 2021 - August 15, 2024
|
|
Dynamic Visual Acuity (DVA)
Time Frame: 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)
|
August 15, 2021 - August 15, 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aimie Kachingwe, Dr., CSUN
- Principal Investigator: Margaret Roller, Dr., CSUN
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)
August 31, 2021
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
May 15, 2024
Study Registration Dates
First Submitted
April 6, 2021
First Submitted That Met QC Criteria
April 6, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Actual)
July 10, 2026
Last Update Submitted That Met QC Criteria
July 8, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Injuries, Traumatic
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Brain Concussion
- Craniocerebral Trauma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Imidacloprid
Other Study ID Numbers
- IRB-FY20-339
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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