Dynamic Vision Testing and Concussion Management Dream Team 65

Concussion, Brain Clinical Trial

Official title:

Dynamic Vision Testing and Concussion Management Dream Team 65

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326555
• Other study ID #: IRB-FY22-022
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2022
• Source: California State University, Northridge
• Contact: Aimie Kachingwe, Dr
• Phone: 818-677-4684
• Email: aimie.kachingwe[@]csun.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Concussion, Brain
• Craniocerebral Trauma
• Head Injury
• Sport Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	California State University, Jacranda Hall 1578, 1576, 1574	Northridge	California

Sponsors (1)

Lead Sponsor	Collaborator
California State University, Northridge

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Condition BESS	Number of errors and time subject was able to hold position	October 1, 2021 - October 1, 2024
Primary	Gaze Stabilization Test (GST)	Maximum head velocity in degrees/second	October 1, 2021 - October 1, 2024
Primary	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)	October 1, 2021 - October 1, 2024