Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT03237468
Status:
UNKNOWN
Last Update Posted:
2021-02-03
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-12', 'size': 509529, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-07-26T12:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-31', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of increase in neck strength in reducing risk of concussion', 'timeFrame': 'One year', 'description': 'Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.'}], 'secondaryOutcomes': [{'measure': 'Effect of baseline neck strength on risk of concussion', 'timeFrame': 'One year', 'description': 'Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['concussion', 'football', 'student', 'athlete', 'sports'], 'conditions': ['Concussion, Brain']}, 'referencesModule': {'references': [{'pmid': '24488820', 'type': 'BACKGROUND', 'citation': 'Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.'}, {'pmid': '25282771', 'type': 'BACKGROUND', 'citation': 'Dugan S, Seymour L, Roesler J, Glover L, Kinde M. This is your brain on sports. Measuring concussions in high school athletes in the Twin Cities metropolitan area. Minn Med. 2014 Sep;97(9):43-6.'}, {'pmid': '23439331', 'type': 'BACKGROUND', 'citation': 'Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in neutral and rotated postures. J Strength Cond Res. 2013 Nov;27(11):3173-82. doi: 10.1519/JSC.0b013e31828a1fe2.'}, {'pmid': '22050943', 'type': 'BACKGROUND', 'citation': 'Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term consequences: effects on normal development profile after concussion. Phys Med Rehabil Clin N Am. 2011 Nov;22(4):683-700, ix. doi: 10.1016/j.pmr.2011.08.009. Epub 2011 Sep 23.'}, {'pmid': '24930131', 'type': 'BACKGROUND', 'citation': 'Collins CL, Fletcher EN, Fields SK, Kluchurosky L, Rohrkemper MK, Comstock RD, Cantu RC. Neck strength: a protective factor reducing risk for concussion in high school sports. J Prim Prev. 2014 Oct;35(5):309-19. doi: 10.1007/s10935-014-0355-2.'}, {'pmid': '24091298', 'type': 'BACKGROUND', 'citation': 'Gutierrez GM, Conte C, Lightbourne K. The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females. Pediatr Exerc Sci. 2014 Feb;26(1):33-40. doi: 10.1123/pes.2013-0102. Epub 2013 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.', 'detailedDescription': 'After recruitment, subjects will have neck strength measured as baseline in addition to doing SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment for concussion. Throughout study, subject will perform basic, unweighted and weighted neck strengthening exercises twice a week. Periodic re evaluations of neck strength will be performed in order to determine progress. Any time a subject incurs a sports related concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared to baseline to measure severity of injury. Weekly follow ups will be done to assess duration of concussion. All measurements, assessments, and exercises are non-invasive and provide minimal risk to subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Involved in programmatic athletic activities with an ongoing duration of at least 4 weeks.\n* Written informed consent obtained by the subject or subject's legal guardian.\n* Written assent from subjects ages 8 years old and above\n* Subject is between the ages of 5 and 22 years, male or female.\n* Subjects from all racial and ethnic origins will have an opportunity to participate.\n\nExclusion Criteria:\n\n\\- Corrected vision less than 20/500."}, 'identificationModule': {'nctId': 'NCT03237468', 'acronym': 'PCONS', 'briefTitle': 'Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion', 'organization': {'class': 'OTHER', 'fullName': 'CentraCare'}, 'officialTitle': 'Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes', 'orgStudyIdInfo': {'id': 'HSR#17-4360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise arm', 'description': 'This arm will perform twice weekly neck strengthening exercises.', 'interventionNames': ['Other: Neck strengthening exercise to prevent concussion']}], 'interventions': [{'name': 'Neck strengthening exercise to prevent concussion', 'type': 'OTHER', 'description': 'Neck strengthening exercise to prevent concussion in student athletes.', 'armGroupLabels': ['Exercise arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Uzma Samadani, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin County Medical Center, Minneapolis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CentraCare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}