Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04360460
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Activity Log', 'timeFrame': 'Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)', 'description': 'ADL Self-Reported Questionnaire\n\nAmount Scale (0-5) 0 = Did not use my weaker arm (not used) 5 = Used my weaker arm as often as before the stroke (same as pre-stroke).\n\nHow well scale (0-5) 0 - My weaker arm was not used at all for that activity (not used). 5 - The ability to use my weaker arm for that activity was as good as before the stroke (normal).'}], 'secondaryOutcomes': [{'measure': "Modified Barthel's Index", 'timeFrame': 'Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)', 'description': 'Quality of Life Self-Reported Questionnaire\n\n80-100 Independent 60-79 Minimally dependent 40-59 Partially dependent 20-39 Very dependent \\<20 Totally dependent'}, {'measure': 'Fugl-Meyer Upper Extremity Assessment', 'timeFrame': 'Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)', 'description': 'Post-stroke upper extremity assessment\n\nVery severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = \\>79'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)', 'description': 'Cognitive Assessment\n\nNo cognitive impairment: MoCA ≥ 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA \\< 20'}, {'measure': 'Functional Independence Measurement Score', 'timeFrame': 'Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)', 'description': 'Functional evaluation\n\n7 - complete independence 6 - modified indepdendence 5 - supervision/Setup 4 - minimal contact assistance 3 - moderate assistance 2 - maximal assistance\n\n1 - total assistance 0 - activity does not occur'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemiparesis as Late Effect of Cerebrovascular Disease']}, 'descriptionModule': {'briefSummary': 'This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.', 'detailedDescription': 'Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-90 years old\n2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital\n3. First time stroke patient\n4. Upper limb hemiparesis\n5. English-speaking\n6. Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb\n\nExclusion Criteria:\n\n1. Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device\n2. Patients with hemicraniectomy\n3. Current uncontrolled seizures\n4. Active infections requiring contact precautions\n5. Cognitively unable to participate\n6. Vision loss limiting ability to participate with VR therapy'}, 'identificationModule': {'nctId': 'NCT04360460', 'briefTitle': 'Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke', 'orgStudyIdInfo': {'id': '5200147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies', 'interventionNames': ['Other: Immersive virtual reality + related functional translation into real-life']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies', 'interventionNames': ['Other: Immersive virtual reality + non-related translation into real-life']}], 'interventions': [{'name': 'Immersive virtual reality + related functional translation into real-life', 'type': 'OTHER', 'description': 'The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.', 'armGroupLabels': ['Experimental']}, {'name': 'Immersive virtual reality + non-related translation into real-life', 'type': 'OTHER', 'description': 'The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Tom and Vi Zapara Rehabilitation Pavilion', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Christopher Tarver, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}