Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT05606393
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment of Virtual Reality System for Stroke Patients With Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central 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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-03', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment', 'timeFrame': 'Baseline and at 1 day after total treatments complete', 'description': 'CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing'}, {'measure': 'Changes of Concise Chinese Aphasia Test (CCAT) scores at 3 months after treatment', 'timeFrame': 'Baseline and at 3 months after total treatments complete', 'description': 'CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'aphasia', 'language rehabilitation', 'stroke'], 'conditions': ['Aphasia']}, 'descriptionModule': {'briefSummary': "Aphasia can significantly influence a person's social relationship and quality of life. To achieve positive language outcomes, an intensive and high-repetition speech therapy is essential. However, due to the limited number of speech therapists, the intensity and frequency of training are often insufficient. Therefore, it is critical to develop other rehabilitation approaches to enhance the benefits of aphasia intervention. Virtual reality (VR) is an immersive and interactive computer simulation technology that can promote the ecological validity of speech therapy. In this study, we develop an innovative VR software for speech training to explore the effects of VR on various aspects of language outcomes.", 'detailedDescription': 'We randomly assigned study participants into 2 groups: the traditional speech therapy (ST) group and the traditional ST with additional VR training (ST+VR) group. In the ST group, each participant received 1-hour traditional ST for each session. In the ST+VR group, an additional 30-minute VR training was administered immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks. For outcome measurement, we administered Concise Chinese Aphasia Test (CCAT) at 3 different time points: before treatment, 1 day and 3 months after the completion of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of stroke with aphasia, including fluent and non-fluent types\n* Age between 20\\~80-year-old\n* Able to understand virtual reality training\n* Able to cooperate with instructions and follow the rules\n* Able to use the virtual reality controller and device\n* Able to sign the subject's informed consent\n\nExclusion Criteria:\n\n* Diagnosis of brain pathology other than stoke, such as brain tumor, Parkinson's disease, dementia\n* Unable to cooperate with the instructions\n* Unable to learn how to use the virtual reality controller and device\n* Any medical diseases or unstable vital signs that may cause safety concern\n* Severe hearing or vision impairments\n* Have ever received any form of speech therapy or virtual reality training"}, 'identificationModule': {'nctId': 'NCT05606393', 'briefTitle': 'Establishment of Virtual Reality System for Stroke Patients With Aphasia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Establishment of Virtual Reality System for Stroke Patients With Aphasia', 'orgStudyIdInfo': {'id': '2021-01-012C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'traditional speech therapy and additional virtual reality training group', 'description': 'Each participant received 1-hour traditional speech therapy(ST) and additional 30-minute VR training immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks.', 'interventionNames': ['Other: virtual reality speech training', 'Other: traditional speech therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional speech therapy group', 'description': 'Each participant received 1-hour traditional speech therapy(ST) only for each session. All participants received 3 sessions of treatment every week for 3 weeks.', 'interventionNames': ['Other: traditional speech therapy']}], 'interventions': [{'name': 'virtual reality speech training', 'type': 'OTHER', 'description': 'virtual reality speech training that focuses on receptive and expressive aspects of language, through a newly developed interactive virtual reality software', 'armGroupLabels': ['traditional speech therapy and additional virtual reality training group']}, {'name': 'traditional speech therapy', 'type': 'OTHER', 'description': 'traditional speech therapy in current clinical use, that focuses on language comprehension, naming, fluency, repetition.', 'armGroupLabels': ['traditional speech therapy and additional virtual reality training group', 'traditional speech therapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Po-Yi Tsai, MD', 'role': 'CONTACT', 'phone': '886-2-2871-2121'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Po-Yi Tsai, MD', 'role': 'CONTACT', 'email': 'pytsai@vghtpe.gov.tw', 'phone': '886-2-2871-2121', 'phoneExt': '7364'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}