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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02954718
Other study ID # 41260
Secondary ID
Status Completed
Phase N/A
First received November 2, 2016
Last updated November 3, 2016
Start date February 2015
Est. completion date November 2016

Study information

Verified date February 2015
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

- Diagnosed as JIA according to ILAR classification

- Aged between 6-18

- At least one affected joint in upper extremity (shoulder, elbow, wrist, and hand joints)

- Adequate cognitive function in the compliance of exercise program

Exclusion Criteria:

• Surgery or arthroscopic operation in the last year

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
activity training


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Outcome

Type Measure Description Time frame Safety issue
Primary Childhood Health Assessment Questionaire (CHAQ) 8 weeks Yes
Primary Canadian Occupational Performance Measure (COPM) 8 weeks Yes
Secondary Duruoz Hand Index 8 weeks Yes
Secondary Jebsen-Taylor Hand Function Test (JTHFT) 8 weeks Yes