Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 8:57 AM
Study NCT ID:
NCT04227132
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2019-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Adaptive Computerized Training for Rehabilitation of Spatial Neglect in Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'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'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "Patients will be informed to take part in an experimental study on the rehabilitation of attention delivered through a computer game. Specific information about the rationale of the study will not be conveyed to patients. Both trainings will be administered, with the aim to support patients' autonomy in performance."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Both experimental and control trainings will be administered consecutively to all patients. Each type of training will be delivered for 10 sessions, with order of training randomized across participants.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2019-12-31', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes at Behavioral Inattention Test (BIT)', 'timeFrame': 'Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training', 'description': 'Diagnostic test for spatial neglect, composed by different subtests of spatial attention'}, {'measure': 'Changes at KF-NAP scale', 'timeFrame': 'Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training', 'description': 'Test for everyday functional outcome'}], 'secondaryOutcomes': [{'measure': 'Changes at Load Test', 'timeFrame': 'Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training', 'description': 'Computerized test on spatial monitoring and multitasking abilities'}, {'measure': 'Changes at Apple Test', 'timeFrame': 'Baseline; immediately after the first training; immediately after the second training; finally after 3 weeks from the end of second training', 'description': 'Test for allocentric and egocentric spatial neglect'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neglect', 'Recovery of function', 'Rehabilitation', 'Videogame', 'Post-stroke'], 'conditions': ['Stroke', 'Spatial Neglect', 'Neglect, Hemispatial', 'Attention Impaired', 'Cerebrovascular Disorders']}, 'referencesModule': {'references': [{'pmid': '34196963', 'type': 'DERIVED', 'citation': 'Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of training with an adaptive computer game, in comparison to standard training, in the rehabilitation of stroke survivors suffering from spatial neglect.', 'detailedDescription': 'Many stroke survivors who have suffered right brain damage show spatial neglect (SN), a deficit of spatial attention orienting that causes unawareness for stimuli located in the left hemispace. Recent data show that the execution of concurrent tasks (that is, multitasking) can worsen the clinical condition and impact functional recovery.\n\nThe aim of this study is to investigate the effect of an adaptive computer game "Labyrinth" previously validated on health population. The videogame is designed for training both attention and execution functions as it engages spatial navigation and multitasking. The effect of the computer game will be compared to standard computerized exercises used for neglect rehabilitation.\n\nThe investigators plan to administer to a sample of 30 stroke patients with SN both Labyrinth and standard trainings for 10 sessions each. The two trainings will be delivered in a randomized crossover design. Improvements of patients\' performance will be registered across trainings and in a follow-up test at 1 month, by assessing the severity of SN and functional everyday outcomes. The investigators expect that patients\' performance will improve following both types of training, but with stronger improvement for the adaptive videogame.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First stroke patients with right brain damage\n* Right-handed\n* Preserved Italian language comprehension to provide informed consensus\n* Clinical signs of spatial neglect (diagnosis by BIT)\n\nExclusion Criteria:\n\n* Prior history of psychiatric or neurological disease\n* Substance abuse\n* Inability to sustain the experimental trainings'}, 'identificationModule': {'nctId': 'NCT04227132', 'acronym': 'MULTITASK', 'briefTitle': 'Evaluation of an Adaptive Computerized Training for Rehabilitation of Spatial Neglect in Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Camillo, Venezia, Italy'}, 'officialTitle': 'Modulation of Visuospatial Awareness During Multi-tasking in Right Hemisphere Stroke Patients: Towards Novel Behavioural and Neurofunctional Predictors of Impairments and Recovery of the Attentional Networks', 'orgStudyIdInfo': {'id': 'RF-2013-02359306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Labyrinth training, then Standard training', 'description': 'Patients will receive at first the Labyrinth training for 10 sessions of 45 minutes, delivered 4 days per week. The, they will undergo the Standard training for 10 sessions of 45 minutes, for around 4 days per week. Before and after each training patients are tested for primary and secondary outcomes with standardized tests.', 'interventionNames': ['Device: Adaptive computer game training']}, {'type': 'EXPERIMENTAL', 'label': 'Standard training, then Labyrinth training', 'description': 'Patients will receive at first the Standard training for 10 sessions of 45 minutes, delivered 4 days per week. Then they will undergo the Labyrinth training for 10 sessions of 45 minutes, for around 4 days per week. Before and after each training patients are tested for primary and secondary outcomes with standardized tests.', 'interventionNames': ['Device: Standard computerized training']}], 'interventions': [{'name': 'Adaptive computer game training', 'type': 'DEVICE', 'description': "Patients sit in front of a computer monitor and play the adaptive videogame with a joystick. The game requires to orient and move inside a maze, and it includes phases that engage multitasking abilities. The level and speed of the game is adapted online to patients' performance.", 'armGroupLabels': ['Labyrinth training, then Standard training']}, {'name': 'Standard computerized training', 'type': 'DEVICE', 'description': "Patients sit in front of the computer monitor and perform simple computerized exercises using a keyboard to respond. Exercises are organized into modules according to the trained cognitive functions. Patients will perform four different modules that are designed for neglect rehabilitation. The level of exercises adapts periodically based on patient's performance.", 'armGroupLabels': ['Standard training, then Labyrinth training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30126', 'city': 'Venice-Lido', 'state': 'Veneto', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Daniela D'Imperio, Ph.D.", 'role': 'CONTACT', 'email': 'daniela.dimperio@ospedalesancamillo.net', 'phone': '0412207183', 'phoneExt': '0039'}, {'name': 'Zaira Romeo, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ospedale San Camillo IRCCS', 'geoPoint': {'lat': 45.4131, 'lon': 12.3742}}], 'centralContacts': [{'name': 'Francesca Meneghello, M.D.', 'role': 'CONTACT', 'email': 'francesca.meneghello@ospedalesancamillo.net', 'phone': '0412207183', 'phoneExt': '0039'}], 'overallOfficials': [{'name': 'Marco Zorzi, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General Psychology, University of Padua, Padua, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Camillo, Venezia, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marco Zorzi', 'investigatorAffiliation': 'University of Padova'}}}}