Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT07257393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fall-risk index (Kinetikos Health App Sit-to-Stand)', 'timeFrame': 'From baseline to 3 months'}], 'secondaryOutcomes': [{'measure': 'UPDRS', 'timeFrame': 'From baseline to 3 months', 'description': 'Change in MDS-UPDRS axial score; Change in MDS-UPDRS Part II'}, {'measure': 'Fall events', 'timeFrame': 'From baseline to 3 months', 'description': 'Fall events during 3 months'}, {'measure': 'LEDD', 'timeFrame': 'From baseline to 3 months', 'description': 'Change in LEDD'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Fall risk', 'Motor fluctuation', 'Dopaminergic medication', 'Mobile health', 'Sit-to-Stand', 'Kinetikos Health App'], 'conditions': ['Idiopathic Parkinsonism']}, 'descriptionModule': {'briefSummary': 'This is a single-center, prospective observational study aiming to validate the Kinetikos Health App for fall risk assessment in PD patients undergoing dopaminergic medication adjustments.', 'detailedDescription': 'Falls are common and disabling in PD. Dopaminergic medication effects on fall risk remain inconclusive. This study validates the Kinetikos Health App for objective fall risk assessment before and after medication adjustment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from outpatient neurology clinic, Shuang Ho Hospital, Taipei Medical University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥20;\n2. PD diagnosis (MDS criteria);\n3. On levodopa monotherapy with motor fluctuations;\n4. Planned to start opicapone or safinamide;\n5. Consent provided.\n\nExclusion Criteria:\n\n1. Atypical/secondary parkinsonism;\n2. Moderate-severe dementia;\n3. DBS/MRgFUS/neurosurgery within 6 months;\n4. Severe comorbidities limiting test'}, 'identificationModule': {'nctId': 'NCT07257393', 'acronym': 'PD_FALLRISK', 'briefTitle': "Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health", 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': "Validation of a Mobile Health Application for Fall Risk Assessment in Parkinson's Disease: A Comparative Study Before and After Dopaminergic Medication Adjustment", 'orgStudyIdInfo': {'id': 'N202511067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Opicapone group', 'description': 'PD patients undergo dopaminergic medication adjustments', 'interventionNames': ['Other: No Intervention: Observational Cohort']}, {'label': 'Safinamide group', 'description': 'PD patients undergoing dopaminergic medication adjustments', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'No intervention.', 'armGroupLabels': ['Opicapone group', 'Safinamide group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '235', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Chen-Chih Chung, MD', 'role': 'CONTACT', 'email': '10670@s.tmu.edu.tw', 'phone': '+886-2-22490088'}], 'facility': 'Shuang Ho Hospital, Taipei Medical University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Chen-Chih Chung, MD', 'role': 'CONTACT', 'email': '10670@s.tmu.edu.tw', 'phone': '+886-2-22490088'}, {'name': 'Chien Tai Hong, MD, PhD', 'role': 'CONTACT', 'email': '15004@s.tmu.edu.tw'}], 'overallOfficials': [{'name': 'Chen-Chih Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD sharing; results published in aggregate'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}