- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954718
Video-Based Task Oriented Activity Training in Patients With Juvenile Idiopathic Arthritis
November 3, 2016 updated by: Saime Nilay Arman, Istanbul University
Effects of Video-Based Task Oriented Activity Training on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
patient-centered task oriented activity training in real life
|
Other Names:
|
|
Experimental: 2
patient-centered video-based task oriented activity training
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Childhood Health Assessment Questionaire (CHAQ)
Time Frame: 8 weeks
|
8 weeks
|
|
Canadian Occupational Performance Measure (COPM)
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duruoz Hand Index
Time Frame: 8 weeks
|
8 weeks
|
|
Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
November 2, 2016
First Submitted That Met QC Criteria
November 2, 2016
First Posted (Estimate)
November 3, 2016
Study Record Updates
Last Update Posted (Estimate)
November 4, 2016
Last Update Submitted That Met QC Criteria
November 3, 2016
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41260
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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