Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT02856360
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Footwear Comfort and Performance in High School Football Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Footwear comfort rating using a 100mm visual analog scale', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Injury incidence', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Football', 'Cleats', 'Stiffness'], 'conditions': ['Foot', 'Footwear']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participate on a club or school sponsored football team\n\nExclusion Criteria:\n\n* Current injury that limits sport participation'}, 'identificationModule': {'nctId': 'NCT02856360', 'briefTitle': 'Changes in Footwear Comfort and Performance in High School Football Players', 'organization': {'class': 'OTHER', 'fullName': 'High Point University'}, 'orgStudyIdInfo': {'id': '16-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate Stiffness', 'description': 'Shoe condition that has moderate stiffness', 'interventionNames': ['Other: Moderate Stiffness Footwear']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Stiffness', 'description': 'Shoe condition that has high stiffness', 'interventionNames': ['Other: High Stiffness Footwear']}], 'interventions': [{'name': 'Moderate Stiffness Footwear', 'type': 'OTHER', 'description': 'Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group', 'armGroupLabels': ['Moderate Stiffness']}, {'name': 'High Stiffness Footwear', 'type': 'OTHER', 'description': 'Standard highly stiff footwear for typical high school football players will be randomly allocated to each group', 'armGroupLabels': ['High Stiffness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Human Biomechanics and Physiology Laboratory', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'High Point University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Adidas International, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}