Dynamic Vision Testing and Concussion Management Dream Team 65

NCT ID: NCT05326555

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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."

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head Injury Sport Injury Concussion, Brain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

California State University, Northridge

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aimie Kachingwe

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aimie Kachingwe, Dr

Role: PRINCIPAL_INVESTIGATOR

CSUN

Margaret Roller, Dr

Role: PRINCIPAL_INVESTIGATOR

CSUN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

California State University, Jacranda Hall 1578, 1576, 1574

Northridge, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aimie Kachingwe, Dr

Role: CONTACT

818-677-4684

Margaret Roller, Dr

Role: CONTACT

818-677-4684

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aimie Kachingwe, Dr

Role: primary

818-677-4684

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-FY22-022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ImPACT Normative Extension
NCT03180905 UNKNOWN NA