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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05326555
Other study ID # IRB-FY22-022
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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