Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT06843733
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-28
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual attention and task switching', 'timeFrame': 'before and immediately after intervention', 'description': 'Trail Making Test'}, {'measure': 'Inhibitory control', 'timeFrame': 'before and immediately after intervention', 'description': 'Color-Word Stroop Test'}, {'measure': 'Single-task performance', 'timeFrame': 'before and immediately after intervention', 'description': 'Box and Block Test'}, {'measure': 'Dual-task performance', 'timeFrame': 'before and immediately after intervention', 'description': 'Box and Block with Serial Sevens Test'}, {'measure': 'Cortical outcomes', 'timeFrame': 'before and immediately after intervention', 'description': 'Transcranial magnetic stimulation was used for measuring the cortical outcomes, which consist of resting motor threshold, input-output curve of motor evoked potentials recruitment and cortical silent period.'}, {'measure': 'Usability', 'timeFrame': 'immediately after Mixed reality exergaming', 'description': 'System usability scale questionnaire was used for measuring the usability of mixed reality exergame. It consists of 10-item, which are typically rated on a five-point scale. A higher SUS score generally indicates better usability.'}, {'measure': 'Motivation', 'timeFrame': 'immediately after Mixed reality exergaming', 'description': 'Intrinsic Motivation Inventory was used for measuring the motivation. It rated on seven-point scale. Higher IMI scores reflect higher levels of motivation.'}, {'measure': 'Adverse side effects', 'timeFrame': 'immediately after Mixed reality exergaming', 'description': 'Cybersickness in Virtual Reality Questionnaire was used for assessing cybersickness symptoms, including nausea, vestibular, and oculomotor. The total score is the sum of the three sub-scores. Each question is presented on a 7-item Likert Scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feasibility study', 'Mixed reality', 'Mild cognitive impairment', 'Executive Dysfunction'], 'conditions': ['Executive Dysfunction', 'Mild Cognitive Impairment (MCI)']}, 'descriptionModule': {'briefSummary': 'The executive dysfunctions are a problem in individuals with MCI which predict conversion to dementia and is positively related to physical activity level. Previous studies found that exercise can prevent executive and physical dysfunctions for people with MCI. However, the motivation is a critical factor in supporting a sustainable exercise. Exergame is combination of exercise and video game. Enjoyment during playing an exergame can support the exercise motivation. Therefore, we will explore the feasibility of using MR exergame in people with MCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Healthy group: 1) MoCA score \\> 24; 2) Independent walking without using gait aids; 3) No diagnosis of the dementia by clinician.\n* MCI group: 1) MoCA score between 16 to 24; 2) Independent walking without using gait aids.\n\nExclusion Criteria:\n\n* Uncontrolled high blood pressure (more than 140/90 mmHg)\n* Hemodialysis\n* Have clinical diagnosis of the disease or symptoms that could influence the performance assessments such as arthritis or severe hand pain which reports by participants and the testing by physiotherapist before testing.\n* History of neurological disorder, such as stroke or other neurodegenerative disorder\n* Taking medicine which affected to functional movement.\n* Unable to follow study protocol.\n* Uncorrected visual or hearing impairment.\n* Positive screening for contraindication of TMS which will be confirmed by TMS screening questionnaire such as uncontrolled seizures.'}, 'identificationModule': {'nctId': 'NCT06843733', 'briefTitle': 'Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes in Healthy Older Adults and People with Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'MU-CIRB 2024/060.2102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild cognitive impairment', 'interventionNames': ['Other: Mixed reality exergame', 'Other: Education']}, {'type': 'OTHER', 'label': 'Healthy older adults', 'interventionNames': ['Other: Mixed reality exergame']}], 'interventions': [{'name': 'Mixed reality exergame', 'type': 'OTHER', 'description': 'The participants will play the Balloon Popping game using Hololens2 (Mixed reality glasses) for one hour. The objective of this game will be to pop all the virtual balloons, focusing on training different executive functions such as inhibitory control and cognitive flexibility. When a participant raises a finger in the air, a virtual needle will appear. After that, the participant will move their finger towards a balloon. Successful contact with a balloon will be indicated by the sound of a pop and the visual effect of confetti.', 'armGroupLabels': ['Healthy older adults', 'Mild cognitive impairment']}, {'name': 'Education', 'type': 'OTHER', 'description': 'The participants will seat on a chair and watch video clip about MCI and dementia for one hour.', 'armGroupLabels': ['Mild cognitive impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73170', 'city': 'Salaya', 'state': 'Changwat Nakhon Pathom', 'country': 'Thailand', 'facility': 'Faculty of Physical Therapy, Mahidol University', 'geoPoint': {'lat': 13.802, 'lon': 100.32111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We will share IPD when we receive the consent from participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Faculty of Physical Therapy, Mahidol University', 'investigatorFullName': 'Rommanee Rojasavastera', 'investigatorAffiliation': 'Mahidol University'}}}}