Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-29 @ 5:50 PM
Study NCT ID:
NCT01120392
Status:
COMPLETED
Last Update Posted:
2011-12-07
First Post:
2010-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in Motor Performance and Quality of Life in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2010-05-10', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '4 weeks (Baseline and after four weeks)', 'description': "Parkinson's disease questionnaire (PDQ-39)"}, {'measure': 'Motor performance', 'timeFrame': '4 weeks (Baseline and after four weeks)', 'description': "the Unified Parkinson's Disease Rating Scale (UPDRS.)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Physical therapy', 'Virtual Reality', 'Quality of life', 'Motor performance'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '38588457', 'type': 'DERIVED', 'citation': "Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3."}, {'pmid': '36602886', 'type': 'DERIVED', 'citation': "Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2."}]}, 'descriptionModule': {'briefSummary': "Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life and motor performance in patients with Parkinson's disease.", 'detailedDescription': "The aim of this study is to assess if the treatment of rehabilitation with Nintendo wii is higher to the conventional in the quality of life and motor performance in patients with Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease\n* Both the sex with age between 50 and 80 years\n* To be in it I serve as apprentice of 1 the 3,0 in the scale of Hoehn Yahr\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Poorly controlled arterial hypertension\n* Poorly controlled Cardiopathy"}, 'identificationModule': {'nctId': 'NCT01120392', 'briefTitle': "Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': "Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'DNEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group - Nintendo wii.', 'interventionNames': ['Other: treatment with Nintendo wii.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional - Physical Therapy', 'interventionNames': ['Other: Physical therapy conventional.']}], 'interventions': [{'name': 'treatment with Nintendo wii.', 'type': 'OTHER', 'description': 'Participants Will receive treatment with Nintendo Wii over one months. These Patients Will Be subjected to mobilization of stem and stretching. Then Will Be Submitted to Nintendo wii games. Will Be Submitted This group three times a week to a treatment protocol with boxing exercises with wii sports and wii fit', 'armGroupLabels': ['Treatment group - Nintendo wii.']}, {'name': 'Physical therapy conventional.', 'type': 'OTHER', 'description': 'Conventional exercises used with the same goals for the group with wii', 'armGroupLabels': ['conventional - Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Ambulatorio Magalhães Neto', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Ailton Melo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UFBA- DINEP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Ailton de Souza Melo', 'investigatorAffiliation': 'Federal University of Bahia'}}}}