Changes in Footwear Comfort and Performance in High School Football Players

Foot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856360
• Other study ID #: 16-004
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 1, 2018

Study information

• Verified date: February 2020
• Source: High Point University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Participate on a club or school sponsored football team

Exclusion Criteria:

• Current injury that limits sport participation

Related Conditions & MeSH terms

• Foot
• Footwear

Intervention

Other:
• Moderate Stiffness Footwear
Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group
• High Stiffness Footwear
Standard highly stiff footwear for typical high school football players will be randomly allocated to each group

Locations

Country	Name	City	State
United States	Human Biomechanics and Physiology Laboratory	High Point	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
High Point University	Adidas International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Footwear comfort rating using a 100mm visual analog scale	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	Injury incidence	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