Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-28 @ 6:06 PM
Study NCT ID:
NCT04855903
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Executive Functions Computerized Rehabilitation Using Virtual Reality to Improve Activities of Daily Living Post-stroke
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': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multiple Baseline case experimental design (N-of-1 trial)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of performance at GAS (Goal Attainment Scaling)', 'timeFrame': 'T3 months', 'description': "Performance in carrying out activities of daily living will be evaluated in an ecological situation using Kiresuk and Sherman's 'Goal Attainment Scaling' (GAS) method. The individual goals to be achieved and performance levels of the GAS will be determined at inclusion, and evaluated twice a week during the three phases (A, B and follow-up phase). The primary outcome will be the evolution of the GAS score evaluated twice a week during 3 months."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['N-of-1 trials', 'cognitive rehabilitation', 'computerized rehabilitation', 'virtual reality', 'executive functions', 'occupational therapy', 'post-stroke rehabilitation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "This research aims to evaluate the effects of a cognitive reeducation carried out with the COVIRTUA Cognition software using a virtual environment, on real-life execution of activities of daily living (ADL) for patients with post-stroke dysexecutive disorders. We will assess patients' performances in achieving ADLs by the Goal Attainment Scaling (GAS) throughout the follow-up (3 months), based on the goals set at the beginning of management with each patient.", 'detailedDescription': "Many post-stroke patients, especially those with frontal lobe lesions, have chronic impairments in mental flexibility, leading to difficulties in decision-making, action planning, or behavioural perseverance. Techniques for remediation of these dysexecutive disorders are often performed in a hospital or in a liberal office. The possible progress resulting from this rehabilitation is rarely transposed into the patient daily life performances, executed in a richer and less controlled environment than the usual place of re-educational. Here, we wish to assess the effective benefits (i.e. in carrying out the activities of daily living) of a computerized rehabilitation program addressing executive functions and based on virtual reality, simulating ADLs. We use in this study a multiple baseline single case experimental design (AB design with a follow-up beyond), including for each patient: pretreatment (phase A), treatment (phase B), and follow-up phase.\n\nPretreatment includes a routine sensitivomotor neurological rehabilitation program that doesn't specifically target executive functions in daily living activities (3 to 5 weeks depending on randomization). Treatment consists in a 4 weeks virtual reality cognitive training program, including four 45-minute sessions per week with an occupational therapist for cognitive rehabilitation in a virtual environment with the COVIRTUA Cognition software. The follow-up phase (5 to 3 weeks depending on randomization) includes no support for executive functions, either in a rehabilitation centre or in a liberal office."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vascular brain injury (stroke), in chronic phase (6 months or more after stroke), responsible for dysexecutive syndrome authenticated by the GREFEX/GRECO battery (Executive Function Evaluation Reflection Group)\n* Men and women over the age of 18\n* Presence of a caregiver\n* Social Security affiliation\n* Signing free and informed consent following clear and detailed information\n* Sufficient understanding of the French language to participate in the study\n\nExclusion Criteria:\n\n* Pregnant women (clinical examination)\n* Alcohol and/or narcotics addiction\n* Major hearing deficit\n* Major visual deficit\n* Neurological pathology other than stroke or psychiatric disorder\n* Unstable epilepsy\n* Patient undergoing rehabilitation at a liberal therapist targeting executive functions during study time\n* Patient under safeguard of justice.\n* Patient simultaneously participating in another research study'}, 'identificationModule': {'nctId': 'NCT04855903', 'acronym': 'RéFEx', 'briefTitle': 'Executive Functions Computerized Rehabilitation Using Virtual Reality to Improve Activities of Daily Living Post-stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Rehabilitation of Executive Functions in the Activities of the Daily Living of Chronic Post-stroke Patients: Using Virtual Reality and Computerized Rehabilitation to Simulate Real Environment for Rehabilitation.', 'orgStudyIdInfo': {'id': 'RC31/19/0552'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 (early phase B)', 'description': '2 phases of cognitive training: Phase A : rehabilitation program in standard ergotherapy during 3 weeks Phase B : cognitive training using Covirtua Cognition software during 4 weeks\n\nThese 2 phases will be followed by a follow-up phase during 5 weeks', 'interventionNames': ['Device: Covirtua Cognition software']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (mid phase B)', 'description': '2 phases of cognitive training: Phase A : rehabilitation program in standard ergotherapy during 4 weeks Phase B : cognitive training using Covirtua Cognition software during 4 weeks\n\nThese 2 phases will be followed by a follow-up phase during 4 weeks', 'interventionNames': ['Device: Covirtua Cognition software']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 (late phase B)', 'description': '2 phases of cognitive training: Phase A : rehabilitation program in standard ergotherapy during 5 weeks Phase B : cognitive training using Covirtua Cognition software during 4 weeks\n\nThese 2 phases will be followed by a follow-up phase during 3 weeks', 'interventionNames': ['Device: Covirtua Cognition software']}], 'interventions': [{'name': 'Covirtua Cognition software', 'type': 'DEVICE', 'description': 'Cognitive training with Covirtua Cognition software', 'armGroupLabels': ['Arm 1 (early phase B)', 'Arm 2 (mid phase B)', 'Arm 3 (late phase B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33523', 'city': 'Bruges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amandine CONSTANT-COOK', 'role': 'CONTACT'}, {'name': 'Amandine CONSTANT-COOK', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre de la Tour de Gassies', 'geoPoint': {'lat': 44.88287, 'lon': -0.61222}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne ALLART', 'role': 'CONTACT'}, {'name': 'Etienne ALLART', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Swynghedauw', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie CATELLA', 'role': 'CONTACT', 'email': 'catella.e@chu-toulouse.fr'}, {'name': 'Claire LEBELY', 'role': 'CONTACT', 'email': 'lebely.c@chu-toulouse.fr'}, {'name': 'Emilie CATELLA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Corentin BIDOU', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xavier DE BOISSEZON', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Emilie CATELLA', 'role': 'CONTACT', 'email': 'catella.e@chu-toulouse.fr', 'phone': '561322986'}, {'name': 'Claire LEBELY', 'role': 'CONTACT', 'email': 'lebely.c@chu-toulouse.fr'}], 'overallOfficials': [{'name': 'Emilie CATELLA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}