Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01658709
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2012-07-31
Brief Title:
Predicting Ankle Injury Through Clinical Functional Measures in Adolescent Athletes
Sponsor:
University of Toledo Health Science Campus
Organization:
University of Toledo
Study Overview
Official Title:
Using Dynamic Postural Control and Functional Testing to Predict Ankle Injury in Adolescent Athletes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 injuriesexposure 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
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 injuriesexposure 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
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 andor cross country during the 20122013 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 20122013 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 injuriesexposure 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
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 andor cross country during the 20122013 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 20122013 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 injuriesexposure 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None