Foot Clinical Trial
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 |
Verified date | February 2020 |
Source | High Point University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Human Biomechanics and Physiology Laboratory | High Point | North Carolina |
Lead Sponsor | Collaborator |
---|---|
High Point University | Adidas International, Inc. |
United States,
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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