FootNCT02856360
Changes in Footwear Comfort and Performance in High School Football Players
A study testing Moderate Stiffness Footwear and High Stiffness Footwear in people with Foot and Footwear, run by High Point University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- What is being tested?
- Moderate Stiffness Footwear and High Stiffness Footwear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participate on a club or school sponsored football team
Who cannot join
- Current injury that limits sport participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Biomechanics and Physiology Laboratory
High Point, North Carolina, 27262
About this study
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.
- Being tested
- Moderate Stiffness Footwear, High Stiffness Footwear
- Keywords
- Football, Cleats, Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Stiffness FootwearOther
Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group
High Stiffness FootwearOther
Standard highly stiff footwear for typical high school football players will be randomly allocated to each group
| Study group | Role | What they receive |
|---|---|---|
| Moderate Stiffness | Experimental | Shoe condition that has moderate stiffness Receives: Other: Moderate Stiffness Footwear |
| High Stiffness | Active comparator | Shoe condition that has high stiffness Receives: Other: High Stiffness Footwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion1 Sep 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Collaborators
- Adidas International, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856360
- Sponsor's protocol ID
- 16-004
- Status last verified
- Feb 2020
- First submitted
- 2 Aug 2016
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Footwear Comfort and Performance in High School Football Players
- ClinicalTrials.gov ID
- NCT02856360
- Acronym / sponsor ID
- 16-004
- Keywords
- Football, Cleats, Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Collaborators
- Adidas International, Inc.
- Study start
- Jul 2016
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Stiffness | Experimental | Other: Moderate Stiffness FootwearShoe condition that has moderate stiffness |
| High Stiffness | Active comparator | Other: High Stiffness FootwearShoe condition that has high stiffness |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participate on a club or school sponsored football team
Key exclusion criteria (1 listed)
- Current injury that limits sport participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Stiffness FootwearStandard moderately stiff footwear for typical high school football players will be randomly allocated to each group | Other | Moderate Stiffness |
| High Stiffness FootwearStandard highly stiff footwear for typical high school football players will be randomly allocated to each group | Other | High Stiffness |
Primary outcome
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.
1 secondary outcome
Injury incidence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Stiffness Footwear and High Stiffness Footwear in people with Foot and Footwear, run by High Point University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Footwear comfort rating using a 100mm visual analog scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.