Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02786433
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Effects on Functional Capacity and Quality of Life of People 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-31', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-05-31', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale - Evaluates disease progression", 'timeFrame': '8 weeks', 'description': 'Through the UPDRS disease progression was evaluated. Composed of 42 items, divided into four parts: mental activity, behavior and mood ; activities of daily living, motor operation and complications of drug therapy. For this study we evaluated the items : activities of daily living and motor examination on . The score for each item ranges from 0 to 4, and the maximum value indicates greater involvement by the disease and the minimum normality.'}, {'measure': "Parkinson's Disease Questionnaire (PDQ-39) - evaluates quality of life", 'timeFrame': '8 weeks', 'description': 'The PDQ-39 is a method that evaluates the quality of life (QOL) in patients with PD through a questionnaire self-explanatory and easy to understand. There are 39 items divided into eight categories: mobility; activities of daily living; emotional well-being; social difficulties of PD; social support; cognition; communication and bodily discomfort. The score ranges from 0 (no problem) to 100 (maximum problem), or a low score indicates a better perception of quality of life.'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Introduction: Parkinson's disease (PD) is a progressive neurodegenerative disorder of dopaminergic neurons that can cause some mobility limitations and it has association with quality of life (QOL) in patients with PD. Virtual reality (VR) has been used to treat of these patients Objective: Evaluate the functional capacity and QOL of individuals with PD using VR with X-Box Kinect®. Methods: Were selected 20 individuals classified as stages 1-3, aged 50-75 years. They were divided by lot into two groups (control and experimental) with ten patients in each. The group (CG) treated with exercises (conventional therapy) during five-week, with two sessions per week lasting 60 minutes, while the experimental group (EG) spent half the time with conventional physical therapy and other half of time in virtual rehabilitation (VR). Subjects were evaluated before and after treatment using the following scales: Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with clinical diagnosis of idiopathic Parkinson's disease\n* Male and female\n* Stage 1-3 of the Hoehn and Yahr scale.\n\nExclusion Criteria:\n\n* Have other neurological diseases\n* They have decompensated systemic diseases\n* Musculoskeletal changes that prevent the achievement of movements\n* With lowering of the cognitive level assessed using the MiniMental State examination with cutoff point according to education\n* With respiratory impairment\n* With medical restrictions for performing exercises\n* In physical therapy, occupational therapy service for 3 months or more;"}, 'identificationModule': {'nctId': 'NCT02786433', 'briefTitle': "Virtual Reality Effects on Functional Capacity and Quality of Life of People With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'orgStudyIdInfo': {'id': 'CAAE: 18732713.0.0000.5193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP CONTROL', 'description': 'Participants in the control group only underwent conventional physiotherapy. Conventional therapy includes stretching and strengthening exercises with cane aid, leggings , elastic band and overball for upper and lower limbs , in addition to gait and balance training.\n\nThe intervention for the control group was applied for five weeks with sessions of 60 minutes twice a week', 'interventionNames': ['Other: conventional physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'EXPERIMENTAL GROUP', 'description': 'The subjects in the experimental group underwent conventional physiotherapy (The same applied in the control group) associated with virtual reality , performed with the console X -Box Kinect® of Microsoft. Durante the achievement of the virtual reality practice, Kinect and Kinect games Adventures® Dance® demanded the anterior movements players -posterior and lateral , as well as jumps and squats to get rid of the game obstacles. They Kinect Dance® game were all required movements of the previous game more dance . The intervention lasted five weeks , with two weekly sessions lasting 30 minutes to conventional therapy and 30 minutes to virtual reality.', 'interventionNames': ['Other: Virtual Reality with X- Box Kinect®']}], 'interventions': [{'name': 'conventional physiotherapy', 'type': 'OTHER', 'armGroupLabels': ['GROUP CONTROL']}, {'name': 'Virtual Reality with X- Box Kinect®', 'type': 'OTHER', 'armGroupLabels': ['EXPERIMENTAL GROUP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Pernambuco Parkinson Association', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Douglas Monteiro da Silva', 'investigatorAffiliation': 'Universidade Federal de Pernambuco'}}}}