Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 1:58 PM
Study NCT ID:
NCT07134569
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Function Assessment and VR-based Motor Training in Adults With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The performance of movement operational assessment', 'timeFrame': '40 minutes', 'description': 'Participants will take movement operational assessment, which composed of different tests, such as Timed Up and Go Test (TUG), the 10-meter walk test (10MWT) and the 6-minute walk test (6WMT)'}, {'measure': 'The performance of motor coordination control', 'timeFrame': '1 hour, twice', 'description': 'the performance recorded with Vicon, an motion capture system, and Single Leg Stance Test'}], 'secondaryOutcomes': [{'measure': 'The N-back Task performance', 'timeFrame': '40 minutes'}, {'measure': 'The performance of Timed Up and Go Test (TUG)', 'timeFrame': '1 minute, twice'}, {'measure': 'The performance of the 10-meter walk test (10MWT)', 'timeFrame': '1 minute, twice'}, {'measure': 'The performance of 6-minute walk test (6WMT)', 'timeFrame': '6 minutes, twice'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'motor training'], 'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if autism affect motor functions, including muscle strength, balance, and motor control? Additionally, understanding the motor functions, cognitive functions, and brain activation in individuals with autism, and verifying whether motor training can effectively improve muscle strength, balance, and motor control. The main questions aim to answer are:\n\n\\[primary hypothesis or outcome measure 1\\]? \\[primary hypothesis or outcome measure 2\\]? If there is a comparison group: Researchers will compare \\[arm information\\] to see if \\[insert effects\\].\n\nParticipants will \\[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\\]."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '\\> The ASD Group\n\nInclusion criteria:\n\n* young adult aged between 18 and 45 years who had a diagnosis of ASD from a licensed mental health or medical professional based on DSM-5.\n* was motivated to complete the 6-week VR-based motor function training.\n* had a full-scale IQ \\> 70 on the WAIS-IV.\n\nExclusion criteria:\n\n* a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis), neurological diseases (e.g., stroke, lumbar radiculopathy, or spinal cord injury) that hamper walking function, or neurosurgery.\n* visual impairment and/or hearing impairment that would preclude participation in motor assessment or training.\n\n * The Non-ASD control group\n\nInclusion criteria:\n\n* young adult aged between 18 and 45 years who do not have a diagnosis of ASD.\n* had a full-scale IQ \\> 70 on the WAIS-IV.\n\nExclusion criteria:\n\n* a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis), neurological diseases (e.g., stroke, lumbar radiculopathy, or spinal cord injury), or neurosurgery that hamper walking function.\n* visual impairment and/or hearing impairment that would preclude participation in motor assessment or training.'}, 'identificationModule': {'nctId': 'NCT07134569', 'briefTitle': 'Motor Function Assessment and VR-based Motor Training in Adults With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Motor Function Assessment and VR-based Motor Training in Adults With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '202311005RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autism', 'interventionNames': ['Behavioral: VR-based motor training']}, {'type': 'NO_INTERVENTION', 'label': 'Typically developing control'}], 'interventions': [{'name': 'VR-based motor training', 'type': 'BEHAVIORAL', 'description': 'Six weeks, twice per week.', 'armGroupLabels': ['Autism']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yi Ling Chien, Clinical Professor', 'role': 'CONTACT', 'email': 'ntuh.peers@gmail.com', 'phone': '+886 2312 3456', 'phoneExt': '266013'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yi Ling Chien, Clinical Professor', 'role': 'CONTACT', 'email': 'ntuh.peers@gmail.com', 'phone': '+886 2-23123456', 'phoneExt': '266013'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}