NCT05819489

Brief Summary

The purpose of this study is to establish baseline reference values for tests of static and dynamic visual acuity and gaze stabilization in collegiate athletes and non-athletes, and to determine if there are differences in vision scores between collegiate athletes and non-athletes with and without a history of concussion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2.7 years

First QC Date

April 6, 2023

Last Update Submit

July 8, 2026

Conditions

Keywords

Baseline Dynamic vision Testing

Outcome Measures

Primary Outcomes (1)

  • Dynamic Visual Acuity (DVA)

    Subjects move their head at approximately 85 degrees per second per the standard test protocol. A metronome automatically generated by the computer assists in maintaining the correct head speed. When the sensor identifies 85 deg/sec, an optotype appears on the screen and the subject verbally identifies the optotype's orientation. This continues with progressively smaller sized letter until the athlete is no longer able to correctly identify the orientation. The computerized system uses a convergence algorithm to determine the accuracy of the response requiring 3 correct answers at the smallest letter size to assign a result. The computer then compares each subject's DVA score to their SVA, which is expressed a Log of minimal angle resolvable units (LogMAR). Simply, the computer considers 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 31, 2021 - May 15, 2024

Secondary Outcomes (2)

  • Gaze Stabilization Test (GST)

    August 31, 2021 - May 15, 2024

  • Static Visual Acuity (SVA) test

    August 31, 2021 - May 15, 2024

Other Outcomes (1)

  • Dynamic Visual Acuity (DVA)

    August 31, 2021 - May 15, 2024

Study Arms (2)

Non-athlete college students with and without history of concussions

Non-athlete subjects included students currently enrolled in a Doctor of Physical Therapy (DPT) program served as a sample of convenience. Non-athlete subjects were excluded if they were over the age of 30 years old to minimize the effect of age in the data analysis.

Diagnostic Test: Dynamic Vision Testing

Students athletes with and without history of concussions

D1 student athletes currently enrolled in a large public university in the Los Angeles area. Subjects volunteered to participate in this study and currently competing in one of the following teams: Men's and Women's soccer, Men's and Women's basketball, Women's water polo or Men's volleyball. Athletes were eligible to participate if they were currently enrolled students, actively participating on the specified teams, provided consent to participate, and were able to complete the testing protocol.

Diagnostic Test: Dynamic Vision Testing

Interventions

Dynamic Vision TestingDIAGNOSTIC_TEST

Dynamic Vision Acuity is tested with the Dynamic Vision Acuity (DVA) and Gaze Stabilization Test (GST) using the Bertec Vision Advantage System.

Also known as: DVA, GST
Non-athlete college students with and without history of concussionsStudents athletes with and without history of concussions

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects were eligible to participate if they were currently enrolled DPT students, provided consent to participate, and were able to complete the testing protocol.

You may qualify if:

  • Currently a California State University Northridge student
  • Provide consent to participate Able to complete the testing protocol.

You may not qualify if:

  • Unable to complete entirety of testing protocol.
  • The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California State University, Northridge, Jacaranda Hall 1578, 1576, 1574

Northridge, California, 91330-8411, 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

  • Aimie Kachingwe, Dr.

    CSUN

    PRINCIPAL INVESTIGATOR
  • Margaret Roller, Dr.

    CSUN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 19, 2023

Study Start

August 31, 2021

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations