Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-07 @ 12:49 AM
Study NCT ID:
NCT03307161
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2017-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020211', 'term': 'Autonomic Dysreflexia'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2017-10-06', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in posture', 'timeFrame': '8 weeks', 'description': 'inches of forward head carriage'}, {'measure': 'change in heart rate variability', 'timeFrame': '8 weeks', 'description': 'heart rate changes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['manual therapy', 'heart rate'], 'conditions': ['Parkinson Disease', 'Dystonia', 'Autonomic Dysreflexia']}, 'descriptionModule': {'briefSummary': 'This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.', 'detailedDescription': 'This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after receiving 8-weekly sessions of the osteopathic manual treatments for truncal flexion dystonia as measured by the distance of the external acoustic meatus from a plumb-line to lateral malleolus, spinal X ray, and heart rate variability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease; able to stand for three minutes or more\n\nExclusion Criteria:\n\n* severe dementia, moderate or severe hallucinations and psychosis; unable to stand for three minutes"}, 'identificationModule': {'nctId': 'NCT03307161', 'briefTitle': "Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia", 'organization': {'class': 'OTHER', 'fullName': 'New York Institute of Technology'}, 'officialTitle': "Osteopathic Manual Treatment of Postural Abnormality, Pain, and Autonomic Control of Cardiac Function in People With Parkinson's Disease and Truncal Dystonia", 'orgStudyIdInfo': {'id': '1130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Parkinsons fwd posture manual treatment', 'description': 'Subject will receive the intervention, osteopathic manual treatment protocol.', 'interventionNames': ['Other: osteopathic manual therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Parkinsons forward posture', 'description': 'Subjects will receive counseling.'}, {'type': 'NO_INTERVENTION', 'label': 'Parkinsons without forward posture', 'description': 'Subjects will receive counseling.'}], 'interventions': [{'name': 'osteopathic manual therapy', 'type': 'OTHER', 'description': 'Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms', 'armGroupLabels': ['Parkinsons fwd posture manual treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11568', 'city': 'Old Westbury', 'state': 'New York', 'country': 'United States', 'facility': 'New York Institute of Technology', 'geoPoint': {'lat': 40.78871, 'lon': -73.59957}}], 'overallOfficials': [{'name': 'Jayme Mancini, PhD DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYIT col osteopathic medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Institute of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}