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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05344703
Other study ID # ArkansasCollegesHlthEd
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 4, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2022
Source Arkansas Colleges of Health Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date August 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 19 Years
Eligibility Inclusion Criteria: - Participates in sport either school sanctioned or club Exclusion Criteria: - History of seizure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Y Balance Plus Visual Perturbations
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.
Diagnostic Test:
Y balance
Subjects will perform Y-balance without any interventional strategies.

Locations

Country Name City State
United States Fort Smith Public Schools Fort Smith Arkansas
United States Greenwood Public Schools Fort Smith Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Arkansas Colleges of Health Education

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Report of concussion in past year Determine if patient sustained concussion since test date utilizing this questionnaire. 1 year
Primary 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
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