Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-30 @ 7:47 AM
Study NCT ID:
NCT06575218
Status:
RECRUITING
Last Update Posted:
2024-08-30
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Virtual Reality Training Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal cognitive assessment scale', 'timeFrame': '12 weeks', 'description': 'MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.'}, {'measure': 'Berg Balance Scale', 'timeFrame': '12 weeks', 'description': 'BBS measures static and dynamic balance in elderly individuals'}, {'measure': 'Time up and Go Test', 'timeFrame': '12 weeks', 'description': 'TUG test evaluates fall risk, mobility and physical performance in the elderly'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. VR technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community.", 'detailedDescription': "The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community. Prospective Randomized Controlled Single Blind Study After the patients and their relatives are informed in detail before the study, they will be asked whether they want to participate in the study and the individuals or relatives of the patients who approve of participating in the study will be asked to sign the informed consent form. Individuals who meet the inclusion criteria will be randomly divided into three groups by a single researcher: Virtual reality training program, cognitive exercise with traditional balance exercises, and traditional balance exercises only."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 55 years and older Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist, MOCA ≥ 16 Clinical Dementia Rating Scale \\< 2\n\nExclusion Criteria:\n\n* Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) Clinically significant aphasia (must be able to understand the therapist's commands) Significant visual or sensory impairment"}, 'identificationModule': {'nctId': 'NCT06575218', 'briefTitle': 'The Effectiveness of Virtual Reality Training Program', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': "The Effectiveness of Virtual Reality Training Program in Community Dwelling Older Adults With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'YeditepeUni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality training group', 'description': 'It will be included in the virtual reality training program to be implemented with the Wii-fit console.', 'interventionNames': ['Other: Conventional exercise and cognitive exercise', 'Other: control']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional exercise and cognitive exercise group', 'description': 'It will be included in the cognitive exercise program along with conventional balance exercises.', 'interventionNames': ['Device: Virtual reality training', 'Other: control']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'no intervention'}], 'interventions': [{'name': 'Virtual reality training', 'type': 'DEVICE', 'description': 'Virtual reality training', 'armGroupLabels': ['Conventional exercise and cognitive exercise group']}, {'name': 'Conventional exercise and cognitive exercise', 'type': 'OTHER', 'description': 'Conventional exercise and cognitive exercise', 'armGroupLabels': ['Virtual reality training group']}, {'name': 'control', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Conventional exercise and cognitive exercise group', 'Virtual reality training group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ebru Akbuğa Koç', 'role': 'CONTACT', 'email': 'ebruakbuga@gmail.com', 'phone': '05548611344'}, {'name': 'Ebru Akbuğa Koç', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ebru Akbuğa Koç', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ebru Akbuga Koc', 'role': 'CONTACT', 'email': 'ebru.akbuga@yeditepe.edu.tr', 'phone': '216'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}