Changes in Footwear Comfort and Performance in High School Football Players

ID: NCT02856360
Status: Enrolling by invitation
Phase: N/A
Start Date: July 01, 2016
First Submitted: August 02, 2016
Last Updated: August 17, 2017
Results: N/A
Organization: High Point University
Sponsors & Collaborators: High Point University, adidas International, Inc.
Location: United States
Conditions: Foot, Footwear
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Study Description

Brief Summary

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Foot

Footwear

Other: Moderate Stiffness Footwear
Other Names
Other: High Stiffness Footwear
Other Names
N/A

Tracking Information

First Submitted DateAugust 02, 2016
Last Update Posted DateAugust 17, 2017
Start DateJuly 01, 2016
Anticipated Completion DateNovember 01, 2019
Primary Completion DateJuly 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleChanges in Footwear Comfort and Performance in High School Football Players
Official Title
Brief Summary

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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
100
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Prevention
Conditions
Foot
Footwear
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Moderate Stiffness Footwear

Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group

Other Names
Other: High Stiffness Footwear

Standard highly stiff footwear for typical high school football players will be randomly allocated to each group

Other Names
Study Groups/Cohorts
Moderate Stiffness
Shoe condition that has moderate stiffness

High Stiffness
Shoe condition that has high stiffness

Study Arms
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

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

Arm Intervention/Treatment
Active Comparator High Stiffness
Shoe condition that has high stiffness
Other : High Stiffness Footwear
Experimental Moderate Stiffness
Shoe condition that has moderate stiffness
Other : Moderate Stiffness Footwear

Recruitment Information

Recruitment Status:Enrolling by invitation
Enrollment100
Completion DateNovember 01, 2019
Eligibility Criteria: Inclusion Criteria:
- Participate on a club or school sponsored football team

Exclusion Criteria:
- Current injury that limits sport participation
GenderAll
Age12 Years to 19 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02856360
Other Study ID Numbers
16-004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
High Point University
Collaborators
adidas International, Inc.
Investigators
Not Available