Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-09 @ 6:07 PM
Study NCT ID:
NCT05965661
Status:
RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'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': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D000080874', 'term': 'Synucleinopathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'VR upper limb hand training or VR control training'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fine finger movements', 'timeFrame': '4 weeks', 'description': 'Coin rotation task (CRT): The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD. The seconds for 20 halfturns will be measured.'}], 'secondaryOutcomes': [{'measure': 'hand dexterity', 'timeFrame': '4 weeks', 'description': 'Nine Hole Peg test (9-HPT): The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD. seconds will be measured.'}, {'measure': 'grip strenght', 'timeFrame': '4 weeks', 'description': 'The handheld JAMAR dynamometer measures the grip strength. kg will be measured.'}, {'measure': 'motor function', 'timeFrame': '4 weeks', 'description': "MDS-Sponsored Revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS III): It evaluates motor aspects of Parkinson's disease"}, {'measure': 'self-reported dexterity related problems in daily living', 'timeFrame': '4 weeks', 'description': 'Dexterity Questionnaire 24 (DextQ-24): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD. score range 24-96, higher scores mean more dexterity problems.'}, {'measure': 'self-reported problems in quality of life', 'timeFrame': '4 weeks', 'description': "Parkinson's Disease Questionnaire (PDQ-39): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating QOL in PD. range 0-156, higher values mean more problems."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'virtual reality training', 'dexterity', 'Parkinsonian Disorders', 'Basal Ganglia Diseases', 'Brain Diseases', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Movement Disorders', 'Neurodegenerative Diseases'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "We investigate the impact of a 4-week virtual reality-based upper limb training in Parkinson's disease. The benefits on dexterity of this training program will be evaluated.\n\nFor these purposes, a randomised, two arm, single assessor blind, parallel design with a monocentric, study setup will be performed.", 'detailedDescription': "Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore the effects of a VR-based upper limb hand training compared to a VR control training, which is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper limb related ADL, and therefore the impact on QoL in patients with PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed PD, according to UK Brain bank Criteria\n* Hoehn \\& Yahr Stadium I to IV\n* Age 40 to 99 years\n* written and signed informed consent\n* self-reported dexterous difficulties\n\nExclusion Criteria:\n\n* MoCA \\<21/30\n* psychiatric disease\n* participation on other interventional trials\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.\n* severe visual impairment'}, 'identificationModule': {'nctId': 'NCT05965661', 'briefTitle': "A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Luzerner Kantonsspital'}, 'officialTitle': "A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease: a Randomized Pilot Study", 'orgStudyIdInfo': {'id': '2022-01545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Virtual reality upper limb hand training', 'description': 'The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.', 'interventionNames': ['Other: virtual reality upper limb hand training']}, {'type': 'OTHER', 'label': 'Virtual reality control training', 'description': 'The PD patients randomized in the control group will receive virtual reality control training.', 'interventionNames': ['Other: virtual reality control training']}], 'interventions': [{'name': 'virtual reality upper limb hand training', 'type': 'OTHER', 'description': 'The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.', 'armGroupLabels': ['Virtual reality upper limb hand training']}, {'name': 'virtual reality control training', 'type': 'OTHER', 'description': 'The PD patients randomized in the control group will receive virtual reality control training.', 'armGroupLabels': ['Virtual reality control training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Manuela Pastore, PhD', 'role': 'CONTACT', 'email': 'manuela.pastore@luks.ch', 'phone': '0412057220'}], 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'centralContacts': [{'name': 'Cornelia Cox, MSc', 'role': 'CONTACT', 'email': 'cornelia.cox@luks.ch', 'phone': '041 205 56 80'}, {'name': 'Manuela Pastore, PhD', 'role': 'CONTACT', 'email': 'manuela.pastore@luks.ch', 'phone': '041 205 72 20'}], 'overallOfficials': [{'name': 'Tim Vanbellingen, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luzerner Kantonsspital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}