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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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 700
Est. completion date
Est. primary completion date September 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 24 Years
Eligibility Inclusion Criteria: - Adolescent Athletes between 14 and 24 - Enrolled in designate area high schools Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Toledo Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic Balance: (Star Excursion Balance Test) Clinical measure of dynamic postural control baseline
Secondary Functional Movement (Functional Movement Screen) Simple functional testing battery baseline
See also
  Status Clinical Trial Phase
Completed NCT02931916 - Evaluation of Reliability and Validity of a Smart-phone Postural Control Assessment Application
Terminated NCT02025569 - The Effect of Strain-counterstrain on Ankle Instability N/A