Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-03 @ 8:18 PM
Study NCT ID:
NCT01186718
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2010-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interexaminer Reliability, Outcomes for Manipulation of Cervical Dysfunction, 3-D Kinematics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2010-08-20', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-D kinematic measurements of cervical motion', 'timeFrame': '9/2009 to 8/2011'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical, motions, kinematics'], 'conditions': ['Human Cervical Motions']}, 'referencesModule': {'references': [{'pmid': '23509819', 'type': 'DERIVED', 'citation': 'Vorro J, Bush TR, Rutledge B, Li M. Kinematic measures during a clinical diagnostic technique for human neck disorder: inter- and intraexaminer comparisons. Biomed Res Int. 2013;2013:950719. doi: 10.1155/2013/950719. Epub 2013 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to quantify 3-dimensional (3-D) cervical motion pattern changes that result from osteopathic manipulation treatment (OMT) in an experimental subject group diagnosed with somatic dysfunction. The kinematic data will include the entire 3-D motion trajectories of the head, resulting in range of motion (ROM) and angular data for the primary and secondary motions.', 'detailedDescription': 'Our primary hypothesis is that kinematic changes will be detected after OMT for motions in the primary direction of the passive diagnostic test motions (cervical side-bending right and left), as well as angular rotations (deviations) occurring around these motions. Our secondary hypothesis is that examination of the kinematic data will provide objective inter- and intra-examiner data to assess similarities/differences occurring during the passive clinical exam before and after OMT. Lastly, we hypothesize that significant differences in the kinematic patterns will result between the two subject groups.\n\nThis experiment is designed for the following clinical and biomechanical observations:\n\n* comparisons of diagnostic data between three osteopathic physicians,\n* comparisons of within-subject kinematic profiles pre- and post-treatment,\n* inter-examiner comparisons of kinematic motion paths occurring during diagnostic motions,\n* evaluate kinematic patterns between the two subject groups, and assess between group similarities/differences,\n* evaluate diagnostic and kinematic data relative to VAS, cervical disability, health status information, and SNF,\n* re-classify aspects of the kinematic data using a cluster (statistical) analysis procedure to compare with initial and secondary physician diagnostic data, and\n* to assess the stability of changes made by the OMT procedures and the kinematic response three days post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Two study groups: Control = subjects with symmetric cervical motion; Experimental = subjects with asymmetric cervical motion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cervical motion symmetry and asymmetry\n\nExclusion Criteria:\n\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT01186718', 'briefTitle': 'Interexaminer Reliability, Outcomes for Manipulation of Cervical Dysfunction, 3-D Kinematics', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Three-dimensional Study of Cervical Kinematics', 'orgStudyIdInfo': {'id': 'AOA 09-05-581'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Control group = functional symmetric cervical motion.'}, {'label': 'Experimental subject group', 'description': 'Experimental subject group = asymmetric cervical motion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}], 'overallOfficials': [{'name': 'Joseph Vorro, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University Dept. Family Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Osteopathic Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and PI', 'investigatorFullName': 'Joseph Vorro', 'investigatorAffiliation': 'Michigan State University'}}}}