Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-28 @ 6:08 PM
Study NCT ID:
NCT02954718
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-Based Task Oriented Activity Training in Patients With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Childhood Health Assessment Questionaire (CHAQ)', 'timeFrame': '8 weeks'}, {'measure': 'Canadian Occupational Performance Measure (COPM)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Duruoz Hand Index', 'timeFrame': '8 weeks'}, {'measure': 'Jebsen-Taylor Hand Function Test (JTHFT)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['activity performance', 'juvenile idiopathic arthritis', 'virtual reality'], 'conditions': ['Video-based Task Oriented Activity Training']}, 'referencesModule': {'references': [{'pmid': '30020092', 'type': 'DERIVED', 'citation': 'Arman N, Tarakci E, Tarakci D, Kasapcopur O. Effects of Video Games-Based Task-Oriented Activity Training (Xbox 360 Kinect) on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):174-181. doi: 10.1097/PHM.0000000000001001.'}]}, 'descriptionModule': {'briefSummary': 'Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood. The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain, stiffness and limitations on daily living activities (DLA) in varying degrees. However, the information about prevalence of symptoms, disorders, DLA limitations, participation restriction and options of treatments for upper extremity involvement in JIA are limited. It has been reported that improvements of upper extremity functions were achieved by video-based games (VBG) in various disease groups. However, in the literature, no study has been found about effectiveness of WBG in children with arthritis. The aim of the study was to investigate effects of task-oriented activity training (TOAT) with VBG versus activity training in real life on activity performance and participation in children with arthritis. Participants with upper limb involvement in JIA were randomly assigned to the activity training in real life group (group I) and TOAT with VBG in real life group (group II). The actual materials and rehabilitation kits will be used for activity training in group 1, the DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity muscle strength and grip, range of motion, upper limb functions, activity, participation and quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG improves the activity performance and physical functions and increases the participation, via being stimulative and interactive in order to provide feedback and to increase interest and motivation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as JIA according to ILAR classification\n* Aged between 6-18\n* At least one affected joint in upper extremity (shoulder, elbow, wrist, and hand joints)\n* Adequate cognitive function in the compliance of exercise program\n\nExclusion Criteria:\n\n• Surgery or arthroscopic operation in the last year'}, 'identificationModule': {'nctId': 'NCT02954718', 'briefTitle': 'Video-Based Task Oriented Activity Training in Patients With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Effects of Video-Based Task Oriented Activity Training on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': '41260'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patient-centered task oriented activity training in real life', 'interventionNames': ['Other: activity training']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'patient-centered video-based task oriented activity training', 'interventionNames': ['Other: activity training']}], 'interventions': [{'name': 'activity training', 'type': 'OTHER', 'otherNames': ['exercise training'], 'armGroupLabels': ['1', '2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Saime Nilay Arman', 'investigatorAffiliation': 'Istanbul University'}}}}