NCT01658709

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
377

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
11.6 years until next milestone

Results Posted

Study results publicly available

July 23, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 31, 2012

Results QC Date

June 3, 2025

Last Update Submit

July 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic Balance: (Star Excursion Balance Test)

    The clinical measure of dynamic postural control is represented as a reaching distance normalized to leg length. This is calculated by taking the average liner reaching distance (cm) of the test trials and dividing by the participant's leg length (anterior superior iliac spine to the inferior pole of the medial malleolus of the tibia), also in cm. The resulting ratio is multiplied by 100 and the measure reported as "% of leg length". This value was established in the literature as the standard outcome for reporting Star Excursion Balance Test data.

    baseline

Study Arms (2)

Ankle Injured

Volunteers with an ankle injury

Healthy

Healthy Volunteers

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toledo

Toledo, Ohio, 43614, United States

Location

Results Point of Contact

Title
Phillip Gribble
Organization
University of Kentucky

Study Officials

  • Phillip Gribble

    University of Toledo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 7, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 23, 2025

Results First Posted

July 23, 2025

Record last verified: 2025-07

Locations