Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-10 @ 3:27 PM
Study NCT ID:
NCT07230366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], '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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait speed', 'timeFrame': 'Before & after training (the training sessions will last for 2~12 weeks).'}], 'secondaryOutcomes': [{'measure': 'Gait length', 'timeFrame': 'Before & after training (the training sessions will last for 2~12 weeks).'}, {'measure': 'Number of falls', 'timeFrame': 'During 2~12 training sessions.'}, {'measure': "Patients' gait confidence scale", 'timeFrame': 'Before & after training (the training sessions will last for 2~12 weeks).'}, {'measure': "Patients' balance function", 'timeFrame': 'Before & after training (the training sessions will last for 2~12 weeks).', 'description': 'Timed-up-and-Go Test'}, {'measure': "Patients' feedback", 'timeFrame': 'Before & after training (the training sessions will last for 2~12 weeks).', 'description': 'Clinical Global Impression (CGI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurodegenerative Diseases, Smart Electric Vehicles, Gait Training'], 'conditions': ["Parkinson's Disease (PD)", 'Dementia']}, 'descriptionModule': {'briefSummary': "This study aims to verify the safety and preliminary clinical benefits of long-term gait training using AI-powered smart electric vehicles for patients with neurodegenerative diseases such as Parkinson's disease and dementia.", 'detailedDescription': 'This study is a single-center, prospective, open-label clinical intervention trial aimed at verifying the clinical safety and preliminary efficacy of an AI-powered smart electric vehicle in gait training for patients with Parkinson\'s disease and dementia. It is expected to recruit 120 participants aged 50-85 years, who will be randomly assigned to different training durations (2\\~12 weeks), with training sessions conducted two or three times a week, each lasting 30 to 60 minutes. The primary assessment indicators include gait speed, number of falls, and gait confidence scale, while secondary assessments include satisfaction and balance function. All study data will be coded and preserved for 10 years. The study is funded by the "Healthy Taiwan Cultivation Plan."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with neurodegenerative diseases (such as Parkinson's disease or dementia).\n2. Age between 50-85 years.\n3. Capable of walking for at least 10 meters, but may have unsteady gait or history of falls.\n4. Able to understand the trial procedures and give informed consent.\n\nExclusion Criteria:\n\n1. Severe cardiopulmonary disease or recent major surgery.\n2. Unable to walk or requiring comprehensive physical support.\n3. Severe cognitive impairment preventing understanding of the trial procedures or giving informed consent.\n4. Visual or auditory impairments severe enough to prevent following trial instructions."}, 'identificationModule': {'nctId': 'NCT07230366', 'briefTitle': 'Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'Clinical Validation of AI-powered Smart Vehicle Assisted Gait Training in Neurodegenerative Disorders', 'orgStudyIdInfo': {'id': 'N202510104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Gait abnormalities in patients with neurodegenerative diseases', 'interventionNames': ['Device: BestShape Go Intelligent Generation Transformable Electric Vehicle']}], 'interventions': [{'name': 'BestShape Go Intelligent Generation Transformable Electric Vehicle', 'type': 'DEVICE', 'description': 'The specific applications of artificial intelligence in intelligent electric vehicles mainly include gait monitoring and analysis, real-time feedback and guidance, autonomous adaptive assistance, safety prevention and warnings, data collection and longterm tracking, as well as adding interactive and entertainment elements.', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '235', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Chien Tai Hong, MD, PhD', 'role': 'CONTACT', 'email': '15004@s.tmu.edu.tw', 'phone': '+886 970747668'}], 'facility': 'Taipei Medical University Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Chien Tai Hong, MD, PhD', 'role': 'CONTACT', 'email': '15004@s.tmu.edu.tw', 'phone': '+886 970747668'}, {'name': 'Likai Huang, MD', 'role': 'CONTACT', 'email': 'greatoriole@gmail.com'}], 'overallOfficials': [{'name': 'Lung Chan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}