Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-08 @ 3:24 PM
Study NCT ID:
NCT06417034
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hand Training Device For Cognitive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-05-12', 'studyFirstSubmitQcDate': '2024-05-12', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygenated hemoglobin (HbO)', 'timeFrame': '30 minutes', 'description': 'The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions'}, {'measure': 'Montreal Cognitive Assessment (MoCA) test', 'timeFrame': '10 minutes', 'description': 'The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: Short term memory, Visuospatial abilities, Executive functions, Attention, concentration and working memory, Language, Orientation to time and place. The sensitivity of MoCA for detecting MCI is 90%.'}, {'measure': 'EN value', 'timeFrame': '5 minutes', 'description': 'The force independence is collected from the data during force control game in each evaluation session. The parameter of force independence is an index of five digits overall enslaving presented as EN.'}], 'secondaryOutcomes': [{'measure': 'Maximum voluntary isometric contraction (MVIC)', 'timeFrame': '10 seconds', 'description': 'Maximum voluntary isometric contraction of each digit is measured for training reference.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional near infrared spectroscopy', 'Parameters of digit force independence', 'Pressing Evaluation and Training System'], 'conditions': ['Healthy Elderly', 'Mild Cognitive Impairment (MCI)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Organization, W.H., Global health and aging. Geneva: World Health Organization, 2011.'}, {'pmid': '3762504', 'type': 'BACKGROUND', 'citation': 'Olshansky SJ, Ault AB. The fourth stage of the epidemiologic transition: the age of delayed degenerative diseases. 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Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with cognitive decline. Therefore, this study aims to develop an advanced systems based on the previous one, that can provide hand function rehabilitation, cognitive training, and emotional comfort for the elderly or people suffer from cognitive deficiency. They can enhance their finger force control or visual to motor synchronization by music embedded during the gaming process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to communicate in Mandarin Chinese or Taiwanese\n* MCI, according to clinical neurological assessment, Montreal Cognitive Assessment (MoCA):≦25\\&≧19\n* Ability to perform ADL independently, no hand function disability\n* Voluntarily participation and ability to sign the informed consent form\n\nExclusion Criteria:\n\n* Alzheimers disease diagnosed by physicians or meeting the diagnostic criteria for dementia\n* Physician's diagnosis of stroke\n* Any mental illness or behavior problems and inability to cooperate with the trainer\n* Visual impairment or hand diseases resulting in an inability to perform finger press\n* received other cognitive or physical training in the past year\n* any sight, hearing, or communication impairment"}, 'identificationModule': {'nctId': 'NCT06417034', 'briefTitle': 'Hand Training Device For Cognitive Care', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Hand Training Device For Cognitive Care', 'orgStudyIdInfo': {'id': 'A-ER-110-485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music-based game training', 'description': 'Subjects will be asked to press their finger while a series of archery target continuously drop down and pass by the bottom line follow the beats of music melody on Tipr.', 'interventionNames': ['Device: Game Software']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non music-based game training', 'description': 'The background music will be disabled. Subjects need to press equally amount of force in certain tolerance that been set by only the visual cue on Tipr.', 'interventionNames': ['Device: Game Software']}], 'interventions': [{'name': 'Game Software', 'type': 'DEVICE', 'description': 'The software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero.', 'armGroupLabels': ['Music-based game training', 'Non music-based game training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Fong-Chin Su, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chair Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair Professor', 'investigatorFullName': 'Fong Chin Su', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}