Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-02 @ 12:10 PM
Study NCT ID:
NCT06317792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be divided into two groups in a randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale score assessment", 'timeFrame': 'Intervention and follow-up period through study completion, an average of 3 years', 'description': "The outcome measure is the Unified Parkinson's Disease Rating Scale score. The UPDRS scale consists of the following six segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, and 4) Complications of Therapy (in the past week) The four segments are made up of 42 items grouped into four subscales. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe)"}, {'measure': 'Tinetti balance and gait score assessment', 'timeFrame': 'Intervention and follow-up period through study completion, an average of 3 years', 'description': 'The score consists of two parts, including the balance score (score=0-16) and gait score (score=0-12), and ranged from 0 to 28 points by summing the points obtained for each of the two tests.'}], 'secondaryOutcomes': [{'measure': 'Fall Risk assessment using Berg Balance Scale', 'timeFrame': 'intervention and follow-up period through study completion, an average of 3 years', 'description': 'The maximum obtainable Berg Balance Scale is 56 and there are four ranges of scores. Patients scoring range of 41-56, 21-40, and 0 -20 indicate low fall risk, medium fall risk, and high fall risk, respectively'}, {'measure': 'Depression severity assessment', 'timeFrame': 'intervention and follow-up period through study completion, an average of 3 years', 'description': 'To obtain a patient-based measurement of depression, the Geriatric Depression Scale (GDS-30) was used. Depression severity was classified using the GDS-30 as follows: No depression (GDS 0-9), mild depression (GDS 10-19), and severe depression (GDS 20-30).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['online exergaming-based physiotherapy', "Parkinson's disease"], 'conditions': ['Parkinsonism in Diseases Classified Elsewhere']}, 'descriptionModule': {'briefSummary': "To validate the efficiency of online exergaming-based physiotherapy. We will enroll patients with Parkinson's disease in postural instability and gait disturbance motor phenotype in the study and divide them into two groups in a randomized controlled study.", 'detailedDescription': 'The investigators will enroll patients in PIGD and divide them into two groups in a randomized controlled study. Participants received an exergaming intervention using the Kinect sensor (Microsoft Corporation, Redmond, WA, USA) from a commercially available exercise system (HappyGoGo, LONGGOOD MEDITECH LTD., Taipei, Taiwan). The Kinect sensor incorporates infrared light and a video camera, which creates a 3D map of the area in front of it. This device provides full-body 3D motion capture.\n\nThe online exergaming-based physiotherapy programs focus on training in shoulder, hip, and knee ROM balance, weight-bearing, strength, weight shifting, and walking based on RF in machine learning to the features selection in patients with PIGD. The training tasks consist of 10 pieces of training (20 minutes per session, five sessions every week, for 8 weeks). Five exergaming programs were used for training, designed to incorporate an appropriate level of challenge to match the ability and fitness of patients with PD.\n\nTo confirm the status of individual training at home, the data will be sent back to the computer output report of the medical side after each training is completed. These data include the quantitative data of a joint ROM, the movement cycle change diagram, and the upper and low limb movements decomposed by each movement plane. The investigators also obtain the trajectory path mapping to understand whether the quality of individual actions is accurate, in place, and line with expected benchmarks.\n\nSafety and Tolerability: If the patient can not complete half of the rehabilitation program, this/her data will be excluded from the analysis.\n\nExergame rehabilitation outcome assessments To evaluate the efficiency and the durability of the training effect. Outcomes were measured at five different periods including Month 0 (pretest) (clinical score, gait cycle, cognitive function, and fMRI), Month 2 (posttest) (clinical score, gait cycle, and fMRI), and Month 8 (follow-up) (clinical score, gait cycle, and cognitive function) and Year 2 and year 3 (follow-up) (clinical score, gait cycle, and cognitive function).\n\n1. Functional Outcome Measure: Clinical scores and parameters of walking gait cycle The Functional Outcome measure includes the (1) UPDRS score, (2) Tinetti balance and gait score, (3) Berg Balance Scale, (4) Time-up to go test, and (5) parameters in the gait cycle including plantar pressure measurement, static and dynamic balance measures, COP trajectory measurements during gait initiation, and spatiotemporal and kinematic gait analysis in straightforward walking and turning through study completion, an average of three years.\n2. Secondary outcome measures include Severity, frequency, and situations of falling and Physical (balance, mobility, freezing of gait, habitual physical activity) and psychological (fear of falling, affect) measures during the intervention and through study completion, an average of three years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1． Clinical diagnosis of Parkinson's disease\n\nExclusion Criteria:\n\n1. Moderate and severe dementia (Clinical Dementia Rating more than or equal to 2)\n2. Advanced PD stage (Hoehn and Yahr staging equal or more than four)"}, 'identificationModule': {'nctId': 'NCT06317792', 'briefTitle': "The Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': "Assessing the Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease: A Validation Study", 'orgStudyIdInfo': {'id': '202201719B0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online exergaming-based physiotherapy intervention group', 'description': 'The training tasks consist of a set of 10 pieces of training (20 min per session, five sessions every week, for 8 weeks)', 'interventionNames': ['Other: online exergaming-based physiotherapy programs']}, {'type': 'NO_INTERVENTION', 'label': 'Online exergaming-based physiotherapy observation group', 'description': 'Observation only'}], 'interventions': [{'name': 'online exergaming-based physiotherapy programs', 'type': 'OTHER', 'description': 'The online exergaming-based physiotherapy programs focus on training in shoulder, hip, and knee ROM balance, weight-bearing, strength, weight shifting, and walking based on RF in machine learning to the features selection in patients with PIGD. The training tasks consist of a set of 10 pieces of training (20 min per session, five sessions every week, for 8 weeks). Five exergaming programs were used for training, designed to incorporate an appropriate level of challenge to match the ability and fitness of patients with PD.', 'armGroupLabels': ['Online exergaming-based physiotherapy intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83304', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Cheng-Hsien Lu, MD', 'role': 'CONTACT', 'email': 'chlu99@adm.cgmh.org.tw', 'phone': '+886975056603'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of neurology', 'investigatorFullName': 'Cheng-Hsien Lu, MD, MSc', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}