NCT05344703

Brief Summary

The Y Balance Test for the lower quarter (YBT-LQ) is a movement screen used to assess an athlete's risk for injury. The YBT-LQ is a dynamic balance test where the participant stands on a single leg and with the opposite lower extremity reaches are far in the anterior direction as they can, and this value is measured. The process is repeated in the posterior medial, and the posterior lateral directions. The final values are controlled for leg length of the participants. The YBT-LQ has been shown to be predictive of lower extremity injury in high school basketball players, but it is typically used as part of a battery of tests to determine the athlete's overall injury risk, but more questions remain to be answered. The research question: Is the YBT-LQ predictive of concussion in high school athletes? What are the norms for YBT-LQ in high school athletes? Does history of concussion effect YBT-LQ? Is the YBT-LQ with visual perturbations predictive of concussions? Is the YBT-LQ with visual perturbations predictive of lower extremity injury? What is the impact of visual perturbations on Y-balance and its injury prevention capability? The target student participants will be 9th through 12th grade students; however, 6th to 8th grade students will be allowed to participate depending on the school or organization request. Informed consent will be obtained reiterating that participation is voluntary. Testing utilizing the YBT-LQ will occur, and sport of participation, age, height, weight, dorsiflexion, and leg length will be obtained. Follow up will be made via the athletic trainers and school personnel to indicate the effected athletes. Once the post-test follow up is complete athletes will be able to see their pre-test scores, and any questions will be answered at that time. This will be a longitudinal study where testing will take place at least two times per year, preferably three times per year over 4 years.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

May 4, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

3.3 years

First QC Date

April 12, 2022

Last Update Submit

April 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Report of concussion in past year

    Determine if patient sustained concussion since test date utilizing this questionnaire.

    1 year

  • Report of lower extremity injury in past year

    This will be determined utilizing intake questionnaire as developed by research team delineating joint or structure impacted by injury.

    1 year

Study Arms (2)

Standard Y Balance

ACTIVE COMPARATOR

Subjects will perform Y-balance lower quarter

Diagnostic Test: Y balance

Y Balance Plus Stroboscopic Glasses

ACTIVE COMPARATOR

Subjects will perform Y-balance lower quarter with and without stroboscopic lenses

Device: Y Balance Plus Visual Perturbations

Interventions

Stroboscopic glasses will be added to the protocol for the participants to perform the Y-balance lower quarter to examine the differences in Y-balance scores as well as examining the Y-balance's ability to predict injury and concussion with visual perturbations.

Y Balance Plus Stroboscopic Glasses
Y balanceDIAGNOSTIC_TEST

Subjects will perform Y-balance without any interventional strategies.

Standard Y Balance

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participates in sport either school sanctioned or club

You may not qualify if:

  • History of seizure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fort Smith Public Schools

Fort Smith, Arkansas, 72916, United States

RECRUITING

Greenwood Public Schools

Fort Smith, Arkansas, 72916, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single group of 6th to 12th graders
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 25, 2022

Study Start

May 4, 2022

Primary Completion

August 30, 2025

Study Completion

December 31, 2025

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations