Predicting Ankle Injury Through Clinical Functional Measures in Adolescent Athletes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Phillip Gribble, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT01658709
First received: July 31, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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
Other Instability, Ankle and Foot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Dynamic Postural Control and Functional Testing to Predict Ankle Injury in Adolescent Athletes

Resource links provided by NLM:


Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:
  • Dynamic Balance: (Star Excursion Balance Test) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Clinical measure of dynamic postural control


Secondary Outcome Measures:
  • Functional Movement (Functional Movement Screen) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Simple functional testing battery


Estimated Enrollment: 700
Study Start Date: September 2012
Estimated Primary Completion Date: September 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ankle Injured
Volunteers with an ankle injury
Healthy
Healthy Volunteers

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.

  Eligibility

Ages Eligible for Study:   14 Years to 24 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 31, 2012
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014