Changes in Footwear Comfort and Performance in High School Football Players

February 25, 2020 updated by: High Point University
The objective of this proposal is to determine the effects of footwear stiffness on a large cohort of high school football players during a football season. The investigators expect that functional athlete groups will be developed, based on subject specific assessments (biomechanical, morphological, performance, comfort), and lead to important translational findings that may impact footwear modification and recommendation to a population of American football players. Two standard cleats will be randomized and provided during a season of high school football. Ratings of comfort, performance, and injury will be collected throughout the season.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Human Biomechanics and Physiology Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participate on a club or school sponsored football team

Exclusion Criteria:

  • Current injury that limits sport participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate Stiffness
Shoe condition that has moderate stiffness
Other: Moderate Stiffness Footwear
Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group
Active Comparator: High Stiffness
Shoe condition that has high stiffness
Other: High Stiffness Footwear
Standard highly stiff footwear for typical high school football players will be randomly allocated to each group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Footwear comfort rating using a 100mm visual analog scale
Time Frame: 3 months
Validated subjective rating of footwear comfort scale. This will be collected weekly during the football season with the average rating utilized at the end of the season. The unit of measure is a 100mm visual analog scale.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury incidence
Time Frame: 3 months
Athletic trainer collected athletic exposures and lower extremity injuries will be collected weekly and combined to determine overall injury rates. The unit of measure is number of injuries per 1000 athletic exposures.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

High Point University

Collaborators

Adidas International, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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