Dynamic Vision Testing and Concussion Management

NCT04837066 | Unknown

• 1 other identifier: IRB-FY20-339
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Injury; Sport Injury; Concussion, Brain

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

Interventions

Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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
• Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
• 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.

Sponsors & Collaborators

• California State University, Northridge: lead

Study Sites (1)

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

Northridge, California, 91330-8411, United States

RECRUITING

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Concussion

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Aimie Kachingwe, Dr.

  CSUN

  PRINCIPAL INVESTIGATOR

• Margaret Roller, Dr.

  CSUN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimie Kachingwe, Dr.

CONTACT

818-677-4684; aimie.kachingwe@csun.edu

Margaret Roller, Dr.

CONTACT

818-677-4684; peggy.roller@csun.edu

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: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)