NCT02856360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

August 2, 2016

Last Update Submit

February 25, 2020

Conditions

FootFootwear

Keywords

FootballCleatsStiffness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Injury incidence

    3 months

Study Arms (2)

Moderate Stiffness

EXPERIMENTAL

Shoe condition that has moderate stiffness

Other: Moderate Stiffness Footwear

High Stiffness

ACTIVE COMPARATOR

Shoe condition that has high stiffness

Other: High Stiffness Footwear

Interventions

Moderate Stiffness FootwearOTHER

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

Moderate Stiffness
High Stiffness FootwearOTHER

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

High Stiffness

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participate on a club or school sponsored football team

You may not qualify if:

  • Current injury that limits sport participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Biomechanics and Physiology Laboratory

High Point, North Carolina, 27262, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2018

Study Completion

November 1, 2018

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)