NCT04837066

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

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

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
2.7 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, 2021

Last Update Submit

July 8, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 6-Condition BESS

    Number of errors and time subject was able to hold position

    August 15, 2021 - August 15, 2024

  • Gaze Stabilization Test (GST)

    Maximum head velocity in degrees/second

    August 15, 2021 - August 15, 2024

  • Dynamic Visual Acuity (DVA)

    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

Study Arms (1)

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.

Diagnostic Test: Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System

Interventions

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.

Student Athletes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

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

Craniocerebral TraumaBrain Concussion

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesHead Injuries, ClosedWounds, 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, 2021

First Posted

April 8, 2021

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