Self-Management Supported Telerehabilitation in Children and Adolescents With Juvenile Idiopathic Arthritis
The Efficacy of Telerehabilitation-Based Self-Management Supported Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Study
1 other identifier
interventional
26
1 country
1
Brief Summary
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease of unknown etiology in childhood. JIA covers several different subgroups and is predominantly manifested by peripheral arthritis. Joint swelling, effusion, tenderness, pain in JIA; causes functional limitations, fatigue and quality of life disorders. Chronic inflammation limits the patient's daily activities and productivity. Self-management is defined as an individual's ability to manage their symptoms, treatment, lifestyle changes, and the psychosocial and cultural consequences of health conditions. Good self-efficacy and coping skills reduce the health and financial burden on the individual as well as on health care, benefiting society in general. Telerehabilitation is the dissemination of rehabilitation services through communication technologies. In the literature, it is seen that the studies on internet-based exercise applications are limited. In the studies, people were encouraged to physical activity with an internet-based application and the benefits of being active were given within the scope of patient education, and it was reported that the level of physical activity effectively improved as a result. It can also increase endurance, has been reported to be safe and feasible. In our study, unlike the literature, the self-management program and exercise applications will be integrated into the internet-based telerehabilitation method, based on the fact that the exercise practices in JIA are effective in disease management and improvement of symptoms. Therefore, in our study; the effectiveness of telerehabilitation-based exercise methods to be applied additionally synchronously and asynchronously to self-management education in children and adolescents with JIA on pain, disease activity, functional status, fatigue, quality of life, psychosocial status, self-efficacy and satisfaction will be examined and compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2022
CompletedStudy Start
First participant enrolled
December 23, 2022
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 6, 2025
February 1, 2025
11 months
December 16, 2022
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)
It assess the disease activity in patients with JIA.
Change from baseline to three months
Childhood Health Assessment Scale (CHAQ)
It assess the children's functional ability over the past week.
Change from baseline to three months
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
It assess the patient's quality of life in pediatric arthritis.
Change from baseline to three months
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-F)
It assess the fatigue in children.
Change from baseline to three months
Secondary Outcomes (4)
Numeric Rating Scale
Change from baseline to three months
5 times sit and stand test
Change from baseline to three months
6-Item Self-Efficacy Scale for Managing Chronic Diseases
Change from baseline to three months
The Juvenile Arthritis Biopsychosocial and Clinical Questionnaire -JAB-Q
Change from baseline to three months
Study Arms (2)
Synchronous Telerehabilitation
EXPERIMENTALOn the basis of telerehabilitation, before starting both synchronous and asynchronous exercise therapy, a comprehensive self-management program will be provided. Self-management training will be shared online synchronously with the participants in this exercise group. The exercise program will consist of functional exercises focused on trunk stabilization, including warm-up and cool-down periods, 3 times a week for 12 weeks, and will be performed online by the physiotherapist. Exercise training will be completed with a 10-minute warm-up exercise followed by 40-minute trunk stabilization and functional exercises for the upper and lower extremities, followed by a 10-minute cooling-down program consisting of flexibility exercises. Progression in exercise training will be done by increasing the number of repetitions and adding elastic bands to the exercises.
Asynchronous Telerehabilitation
ACTIVE COMPARATORSelf-management training will be delivered to the participants in this exercise group via video and they will be asked to watch it. The exercise program will consist of functional exercises focused on trunk stabilization, including warm-up and cool-down periods, 3 times a week for 12 weeks, and will be shared with the participants through videos taken by the physiotherapist. Exercise training will be completed with a 10-minute warm-up exercise followed by 40-minute trunk stabilization and functional exercises for the upper and lower extremities, followed by a 10-minute cooling-down program consisting of flexibility exercises. Participants will be checked weekly by phone to determine exercise tracking. Progression in exercise training will be achieved with new videos that include an increase in the number of repetitions of the participants and the addition of elastic bands to the exercises.
Interventions
Supporting the exercises with an internet-based environment and self-management training for Children and Adolescents with Juvenile Idiopathic Arthritis
Eligibility Criteria
You may qualify if:
- Having been diagnosed with Juvenile Idiopathic Arthritis according to ILAR diagnostic criteria
- years old
- Agreeing to do the exercises throughout the study
- Stable symptoms and medications
- Internet and computer access
You may not qualify if:
- Be younger than 8 years old
- Surgical or arthroscopic operation in the last 1 year
- Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
- Presence of active synovitis and arthritis
- Active vestibular disease
- Family and patient's inability to adapt to the assessment
- Having a psychiatric illness that affects cooperation
- Having heart failure and lung pathology at a level that will affect activities of daily living
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University School of Physical Therapy and Rehabilitation
Denizli, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bilge Basakci Calik, Prof. Dr.
Pamukkale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Msc. Lecturer, Specialist Physiotherapist
Study Record Dates
First Submitted
December 16, 2022
First Posted
November 3, 2023
Study Start
December 23, 2022
Primary Completion
November 30, 2023
Study Completion
June 1, 2024
Last Updated
February 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share