Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
Study NCT ID:
NCT06275516
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2024-02-17', 'studyFirstSubmitQcDate': '2024-02-17', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer scale', 'timeFrame': '30 days (Adjust according to the actual situation of patients)', 'description': 'Motor function assessment'}, {'measure': 'Berg balance scale', 'timeFrame': '30 days (Adjust according to the actual situation of patients)', 'description': 'Balance function evaluation'}, {'measure': 'three-dimensional gait detection', 'timeFrame': '30 days (Adjust according to the actual situation of patients)', 'description': 'Quantitative motor function assessment'}, {'measure': 'Fall incidents', 'timeFrame': '30 days (Adjust according to the actual situation of patients)', 'description': 'Safety assessment'}, {'measure': 'Dizzy incidents', 'timeFrame': '30 days (Adjust according to the actual situation of patients)', 'description': 'Safety assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.', 'detailedDescription': "This was single-blind randomized controlled intervention study. Each stroke subject underwent screening period, baseline assessment period, intervention period, endpoint assessment period.\n\nThe screening period include the verification of inclusion/exclusion criteria and the acquisition of informed consent.\n\nBaseline and endpoint assessment period include motor function related scales were evaluated (muscle strength, muscle tone, Fugl-Meyer scale, Berg balance scale); cognitive function related scale assessment \\[Brief Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test, Shape connection test A.B, standardized digital modal experiment, auditory word Learning Test\\], emotional correlation scale assessment (Hamilton Depression Scale, Hamilton Anxiety Scale), and activity of daily living scale ADL scale. Meanwhile, quantitative evaluation of motor function three-dimensional gait detection and assessment of brain functional activation (fNIRs tests and fMRI) were synchronously completed.\n\nThe intervention period included multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity in the experimental group and only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).\n\nPreliminary validation of effectiveness assessment includes Fugl-Meyer scale, Berg balance scale, and three-dimensional gait detection. Preliminary validation of the safety assessment includes fall and dizzy incidents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment\n2. 18-85 years old\n3. Be able to walk with minor assistance\n4. Can tolerate the rehabilitation training of this experiment\n5. First stroke\n6. Be able to follow instructions to complete the test\n7. Patients who signed informed consent\n\nExclusion Criteria:\n\n1. The test could not be tolerated due to organic disease\n2. There is a serious mental illness resulting in inability to cooperate with or tolerate this test\n3. is participating in another clinical trial involving an investigational drug or physical therapy\n4. Patients who have not signed informed consent'}, 'identificationModule': {'nctId': 'NCT06275516', 'briefTitle': 'Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients', 'orgStudyIdInfo': {'id': '2024-208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR+treadmill training group', 'description': "Multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).", 'interventionNames': ['Device: multi-sensory stimulation immersive VR+ treadmill training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'treadmill training group', 'description': "Only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).", 'interventionNames': ['Device: treadmill training']}], 'interventions': [{'name': 'multi-sensory stimulation immersive VR+ treadmill training', 'type': 'DEVICE', 'description': 'Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group', 'armGroupLabels': ['VR+treadmill training group']}, {'name': 'treadmill training', 'type': 'DEVICE', 'description': 'Only treadmill training in treadmill training group', 'armGroupLabels': ['treadmill training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ding Qun Bai, Ph.D.', 'role': 'CONTACT', 'email': 'baidingqun@hospital.cqmu.edu.cn', 'phone': '023-89011334'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University, First Branch', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Dingqun Bai', 'role': 'CONTACT', 'email': 'baidingqun2014@163.com', 'phone': '023-89011334'}, {'name': 'Zheng Yang', 'role': 'CONTACT', 'email': 'zhengyangvivi@gmail.com'}], 'overallOfficials': [{'name': 'Dingqun Bai', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'First Affiliated Hospital of Chongqing Medical University', 'investigatorFullName': 'Dingqun Bai', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}