Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 6:56 PM
Study NCT ID:
NCT04541992
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensors Prediction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-12', 'releaseDate': '2025-08-22'}, {'resetDate': '2025-10-09', 'releaseDate': '2025-09-16'}], 'estimatedResultsFirstSubmitDate': '2025-08-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Region of Limb Stability', 'timeFrame': 'Day 1', 'description': 'Region of Limb Stability (ROLS) measured in cm\\^2 using a body-worn sensor.'}, {'measure': 'Transitional Angular Displacement of Segments', 'timeFrame': 'Day 1', 'description': 'Transitional Angular Displacement of Segments (TADS) measured in degrees per second using a body-worn sensor.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip injury', 'knee injury', 'ankle injury'], 'conditions': ['Injury Leg']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether measures of balance and agility can help predict if a Service Member may be at risk for an injury to their legs before beginning their school and training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy service member participants stationed at Fort Bragg, North Carolina.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between the ages of 18-55\n2. Active duty Service Members in the 82nd Airborne Division (ABN DIV)\n3. Fluent in English speak and reading\n\nExclusion Criteria:\n\n1. Service members under the age of 18 or over the age of 55 will be excluded\n2. Told by a doctor that they should not exercise.\n3. Orthopedic injury/surgery of the lower limb or back within the last year and that limits study compliance\n4. Regular use of medications that may alter balance, coordination or agility\n5. Unwilling to comply with the study protocol'}, 'identificationModule': {'nctId': 'NCT04541992', 'briefTitle': 'Sensors Prediction Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Body-Worn Sensors for Risk of Injury Prediction During Military Training', 'orgStudyIdInfo': {'id': '20190910'}, 'secondaryIdInfos': [{'id': 'HU00011920011', 'type': 'OTHER_GRANT', 'domain': 'Geneva Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Airborne Group', 'description': 'Participants in this group will be tested for balance and agility within a 20 minute time frame.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28310', 'city': 'Fort Bragg', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Gornoski', 'role': 'CONTACT', 'email': 'lgornoski@genevausa.org', 'phone': '305-284-2351'}, {'name': 'Robert Gailey, PhD', 'role': 'CONTACT'}], 'facility': 'Womack Army Medical Center', 'geoPoint': {'lat': 35.139, 'lon': -79.00603}}], 'centralContacts': [{'name': 'Natasha Crowther', 'role': 'CONTACT', 'email': 'ncrowther@miami.edu', 'phone': '305-284-2351'}], 'overallOfficials': [{'name': 'Robert Gailey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Geneva Foundation', 'class': 'OTHER'}, {'name': 'Uniformed Services University of the Health Sciences', 'class': 'FED'}, {'name': 'Womack Army Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Gailey', 'investigatorAffiliation': 'University of Miami'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-22', 'type': 'RELEASE'}, {'date': '2025-09-12', 'type': 'RESET'}, {'date': '2025-09-16', 'type': 'RELEASE'}, {'date': '2025-10-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Robert Gailey, Professor, University of Miami'}}}}