Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT01658709 |
Other study ID # |
UTHSC-15 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 2012 |
Study information
Verified date |
May 2024 |
Source |
University of Toledo |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to determine if a clinical measure can be used effectively to
predict ankle injury in high school and collegiate athletes across a variety of sports.
Hypothesis: For each ankle injury category (lateral ankle sprain, medial ankle sprain,
syndesmosis ankle sprain, Achilles rupture, fracture) participants that suffer these injuries
will have a significantly lower SEBT normalized composite score and FMS composite score
compared to those participants that do not suffer the injury
Hypothesis #1b: Similar to a previous study examining high school basketball players22, using
receiver operator characteristic (ROC) curves, we will be able to calculate likelihood
ratios, odds ratios, sensitivity and specificity and determine the ideal cut-off point of the
SEBT normalized composite score and FMS composite score that will be able to predict the risk
of each ankle injury category (lateral ankle sprain, medial ankle sprain, syndesmosis ankle
sprain, Achilles rupture, fracture).
Athletes from identified sites will perform measures of the star excursion balance test
(SEBT) and the Functional Movement Screen FMS before the first day of practice. During the
competition season, the number of practice and competition person exposures, as well as the
number of ankle injuries, will be recorded. The rate of ankle injuries/exposure will be
calculated and compared with the pre-season SEBT scores to create a simple and a complex
prediction model for risk of ankle injury
Description:
The objective of this study is to determine if a clinical measure of dynamic postural
control, the star excursion balance test (SEBT), and a simple functional testing battery, the
Functional Movement Screen (FMS), can be used effectively to predict ankle injury in high
school and collegiate athletes across a variety of sports.
Males and females between the ages of 14 and 24 enrolled at one of three designated high
schools in Toledo, OH or at the University of Toledo will be recruited for this study.
Eligible participants will be signed up and medically cleared to participate in football,
basketball, baseball, softball, soccer, volleyball, and/or cross country during the 2012/2013
academic year. Participants will be healthy and must be cleared by a physician for full
participation at the time of enrollment in the study. All the enrolled student athletes will
be made aware of the study and the requested prior to their pre-season physicals by the
coaching staff and ATC prior to the beginning of the first day of practice. Consent and
assent will be obtained using appropriate university approved forms. In this prospective
study design, pre-season dynamic postural control data and previous injury history will be
collected from the high school and collegiate athletes. These athletic facilities are all
serviced by certified Athletic Trainers (ATC) and physicians associated with the University
of Toledo and the University of Toledo Medical Center. Prior to the beginning of the
2012/2013 competition seasons, athletes from the identified sites will, as part of their
pre-season physical exam requirements, perform measures of the SEBT and the FMS before the
first day of practice. The performance of the SEBT and the FMS are explained in detail in the
attached protocol. During the competition season, the number of practice and competition
person exposures, as well as the number of ankle injuries, will be recorded by the ATC at
each school. Injury incidence is explained in detail in the attached protocol. At the end of
the competition seasons, the rate of ankle injuries/exposure will be calculated and compared
with the pre-season SEBT scores to create a simple and a complex prediction model for risk of
ankle injury.