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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02856360
Other study ID # 16-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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