Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-13 @ 12:35 PM
Study NCT ID:
NCT03877367
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2019-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Balance Changes After Chiropractic Adjustments in Health Adults.
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study will be a patient and outcome assessor blinded, cross-over randomized clinical trial. Participants will randomized into two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Head Sensor to calculate angle of head inclination', 'timeFrame': '30 seconds', 'description': "There will be a sensor placed on each participant's head (in a neoprene headband), as well as on the midpoint of the tube. The head sensor will be used to calculate the angle of head inclination. The sensor on the tube will be used to calculate Sample Entropy as well as general kinematics."}], 'secondaryOutcomes': [{'measure': 'Ground reaction force', 'timeFrame': 'less than 1 minute', 'description': 'Participants will be standing on a force plate that will characterize their ground reaction forces, eyes open without tube (EONT) versus eyes closed without the tube (ECNT).'}, {'measure': 'Center of pressure', 'timeFrame': 'less than 1 minute', 'description': 'Participants will be standing on a force plate that will characterize their center of pressure, EONT versus eye open with the tube horizontally (EOWT).'}, {'measure': 'Velocity to measure sway.', 'timeFrame': 'less than 1 minute', 'description': 'Participants will be standing on a force plate that will characterize their velocity of sway, EOWT versus eye closed with tube held horizontally (ECWT).'}, {'measure': 'Sway: measuring distance', 'timeFrame': 'less than 1 minute', 'description': 'Participants will be standing on a force plate that will characterize their distance of sway, EOWT versus ECWT.'}, {'measure': 'acceleration to measure sway', 'timeFrame': 'less than 1 minute', 'description': 'Participants will be standing on a force plate that will characterize their acceleration of sway, EOWT versus ECWT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chiropractic manipulation', 'Extremity manipulation', 'Balance task'], 'conditions': ['Postural Balance', 'Musculoskeletal Manipulation']}, 'referencesModule': {'references': [{'pmid': '33541378', 'type': 'DERIVED', 'citation': 'Malaya CA, Haworth J, Pohlman KA, Smith DL. Immediate impact of extremity manipulation on dual task performance: a randomized, crossover clinical trial. Chiropr Man Therap. 2021 Feb 5;29(1):6. doi: 10.1186/s12998-021-00366-5.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the effect of upper and lower extremity manipulations on an upper extremity balancing task.', 'detailedDescription': 'Spinal manipulation has long been thought to have beneficial effects on posture, balance and proprioception; however, only a single study has investigated the effect of chiropractic treatment of the extremities on balance and posture. In a previous study, it was noted that lower extremity manipulation led to more ordered behavior on a dynamic, lower extremity balance task. It was also found that upper extremity manipulation led to less ordered behavior with same lower extremity balance task. Further studies are needed not only to validate this theory, but to further clarify the mechanism regarding specificity of manipulation to task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the age 18 years old and 35 years old\n* Cleared to be treated in Parker Wellness Clinic\n\nExclusion Criteria:\n\n* Hx of neurological disorders\n* Hx of musculoskeletal disorders/injuries that could impact his/her ability to stand upright\n* Currently known to be pregnant\n* Compromised vision (beyond the wearing of corrective lenses)'}, 'identificationModule': {'nctId': 'NCT03877367', 'briefTitle': 'Comparison of Balance Changes After Chiropractic Adjustments in Health Adults.', 'organization': {'class': 'OTHER', 'fullName': 'Parker University'}, 'officialTitle': 'Immediate Impact of Extremity Manipulation on an Upper Extremity (UE) Balancing Task', 'orgStudyIdInfo': {'id': 'Parker19_03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upper Extremity Group, Day 1', 'description': 'Day 1: This group will receive a pre-test, upper extremity intervention, and post-test.\n\nDay 2: This group will receive a pre-test, lower extremity intervention, and post-test.', 'interventionNames': ['Other: Upper extremity manipulation']}, {'type': 'EXPERIMENTAL', 'label': 'Lower Extremity Group, Day 2', 'description': 'Day 1: This group will receive a pre-test, lower extremity intervention, and post-test.\n\nDay 2: This group will receive a pre-test, upper extremity intervention, and post-test.', 'interventionNames': ['Other: Upper extremity manipulation']}], 'interventions': [{'name': 'Upper extremity manipulation', 'type': 'OTHER', 'otherNames': ['Manipulation'], 'description': 'An upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series.', 'armGroupLabels': ['Lower Extremity Group, Day 2', 'Upper Extremity Group, Day 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75229', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parker University', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parker University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Houston', 'class': 'OTHER'}, {'name': 'Whittier University', 'class': 'UNKNOWN'}, {'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'Private Practice', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}