Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT03402360
Status:
UNKNOWN
Last Update Posted:
2019-06-17
First Post:
2018-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality Rehabilitation in Patients With Acquired Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Resting state functional MRI (fMRI)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)'}], 'primaryOutcomes': [{'measure': 'Change in Fugl-Meyer Upper Extremity (FMUE)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)', 'description': 'Items are scored on a 3-point ordinal scale\n\n0 = cannot perform; 1 = performs partially; 2 = performs fully.\n\nMaximum Score = 66 points'}], 'secondaryOutcomes': [{'measure': 'Change in Action Research Arm Test (ARAT)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)'}, {'measure': 'Change in Functional Independence Measures (FIM)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)'}, {'measure': 'Change in Mini Mental State Examination (MMSE)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)'}, {'measure': 'Change in Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)'}, {'measure': 'Change in Beck Depression Inventory (BDI)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)'}, {'measure': 'Change in 36-Item Short Form Survey (SF-36)', 'timeFrame': 'From Baseline (T0) to 3 weeks of rehabilitation (T1)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Rehabilitation', 'Acquired Brain Injury'], 'conditions': ['Acquired Brain Injury']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acquired Brain Injury within 1 month before the recruitment;\n* Score between 0 and 3 at the Motor Arm subscore of the Italian version of the National Institutes of Health Stroke Scale (it-NIHSS);\n* Score between 9 and 15 at the Glasgow Coma Scale for the traumatic brain injury Acquired Brain Injury.\n\nExclusion Criteria:\n\n* Denial of informed consent;\n* Visual deficits that interfere with the virtual reality rehabilitation;\n* Score under 18 at the Mini Mental State Examination;\n* Severe orthopedic deficit;\n* Patients with pace maker;\n* Patients with contraindication to undergo magnetic resonance;\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT03402360', 'briefTitle': 'Virtual Reality Rehabilitation in Patients With Acquired Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'VR-ABI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality rehabilitation group', 'description': 'The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.', 'interventionNames': ['Other: Virtual Reality rehabilitation group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.', 'interventionNames': ['Other: Control group rehabilitation']}], 'interventions': [{'name': 'Virtual Reality rehabilitation group', 'type': 'OTHER', 'description': 'Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks).\n\n1 hour: conventional physiotherapy\n\n1 hour: virtual reality upper extremity motor rehabilitation\n\n1 hour: virtual reality neurocognitive training', 'armGroupLabels': ['Virtual Reality rehabilitation group']}, {'name': 'Control group rehabilitation', 'type': 'OTHER', 'description': 'Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks).\n\n1 hour: conventional physiotherapy\n\n1 hour: upper extremity motor rehabilitation\n\n1 hour: neurocognitive training', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'contacts': [{'name': 'Sandro Iannaccone', 'role': 'CONTACT', 'email': 'iannaccone.sandro@hsr.it', 'phone': '0226435734', 'phoneExt': '0039'}], 'facility': 'IRCSS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Sandro Iannaccone', 'role': 'CONTACT', 'email': 'iannaccone.sandro@hsr.it', 'phone': '0226435734', 'phoneExt': '0039'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Neuro Rehabilitation Unit, Principal Investigator', 'investigatorFullName': 'Sandro Iannaccone', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}