Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT04664920
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Individualized Exergame Training Solution for People With Major Neurocognitive Disorder: a Usability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance questionnaire', 'timeFrame': '2 years', 'description': "users' individual acceptance"}, {'measure': 'Game experience questionnaire', 'timeFrame': '2 years', 'description': "users' game experience"}, {'measure': 'Guideline-based qualitative interview', 'timeFrame': '2 years', 'description': "Users' opinions and feedback"}, {'measure': 'System usability questionnaire', 'timeFrame': '2 years', 'description': 'System usability scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Neurocognitive Disorder', 'Physical Activity', 'Dementia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia).', 'detailedDescription': 'The aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia). On one appointment, the participants will perform a user-centered exergame for about 30 minutes. The exergame will include specific cognitive and motor functions. As the difficulty of the training game is user-centered, the participants will always be challenged on an appropriate level. Stepping exercises will be used to control the video game scenario. The video game scenario will include different cognitive functions. The body movements will include different physical aspects including balance, strength and Pelvic Floor Muscle Training (PFMT). During the exergame performance, different qualitative assessments will be performed to determine usability of the exergame including acceptance and game experience protocol (think aloud method). After the exergame performance, the participant will answer individual and guideline-based interview questions about usability including their individual experiences (duration about 20 min). This study contributes to fundamental research investigating how user-centered exergame training can be applied in older adults with individual needs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Residents of long-term care facility 'de Wingerd'.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60+ years\n* Live in long-term care facility "de Wingerd"\n* Being diagnosed with major neurocognitive disorder by a specialist doctor\n* Standing straight for minimal 10 minutes without aids\n* Visual acuity with correction sufficient to work on a TV screen\n\nExclusion Criteria:\n\n* Mobility impairments that don\'t allow to play the exergame\n* Severe acute or uncontrolled health problems (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)\n* Orthopaedic or neurological diseases that inhibit Exergame training\n* Rapidly progressive or terminal illness'}, 'identificationModule': {'nctId': 'NCT04664920', 'briefTitle': 'An Individualized Exergame Training Solution for People With Major Neurocognitive Disorder: a Usability Study', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'An Individualized Exergame Training Solution for People With Major Neurocognitive Disorder: a Usability Study', 'orgStudyIdInfo': {'id': '052020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': 'Exergame intervention arm.', 'interventionNames': ['Device: exergame']}], 'interventions': [{'name': 'exergame', 'type': 'DEVICE', 'description': 'motor-cognitive training device', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'De Wingerd', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Davy Vancampfort', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Davy Vancampfort', 'investigatorAffiliation': 'KU Leuven'}}}}