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Predicting Ankle Injury Through Clinical Functional Measures in Adolescent Athletes

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ClinicalTrials.gov Identifier: NCT01658709
Recruitment Status : Active, not recruiting
First Posted : August 7, 2012
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Phillip Gribble, University of Toledo Health Science Campus

Study Description
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Brief 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


Condition or disease
Other Instability, Ankle and Foot

Detailed 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.


Study Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Dynamic Postural Control and Functional Testing to Predict Ankle Injury in Adolescent Athletes
Study Start Date : September 2012
Estimated Primary Completion Date : September 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Ankle Injured
Volunteers with an ankle injury
Healthy
Healthy Volunteers


Outcome Measures
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Primary Outcome Measures :
  1. Dynamic Balance: (Star Excursion Balance Test) [ Time Frame: baseline ]
    Clinical measure of dynamic postural control


Secondary Outcome Measures :
  1. Functional Movement (Functional Movement Screen) [ Time Frame: baseline ]
    Simple functional testing battery


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Males and female athletes 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.
Criteria

Inclusion Criteria:

  • Adolescent Athletes between 14 and 24
  • Enrolled in designate area high schools

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658709


Locations
United States, Ohio
University of Toledo
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
Principal Investigator: Phillip Gribble University of Toledo
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Phillip Gribble, Principal Investigator, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT01658709     History of Changes
Other Study ID Numbers: UTHSC-15
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries