- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06115954
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Denizli, Turkey
- Pamukkale University School of Physical Therapy and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having been diagnosed with Juvenile Idiopathic Arthritis according to ILAR diagnostic criteria
- 8-18 years old
- Agreeing to do the exercises throughout the study
- Stable symptoms and medications
- Internet and computer access
Exclusion Criteria:
- 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
Study Plan
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: Synchronous Telerehabilitation
On 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. |
Supporting the exercises with an internet-based environment and self-management training for Children and Adolescents with Juvenile Idiopathic Arthritis
|
|
Active Comparator: Asynchronous Telerehabilitation
Self-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.
|
Supporting the exercises with an internet-based environment and self-management training for Children and Adolescents with Juvenile Idiopathic Arthritis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)
Time Frame: Change from baseline to three months
|
It assess the disease activity in patients with JIA.
|
Change from baseline to three months
|
|
Childhood Health Assessment Scale (CHAQ)
Time Frame: Change from baseline to three months
|
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
Time Frame: Change from baseline to three months
|
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)
Time Frame: Change from baseline to three months
|
It assess the fatigue in children.
|
Change from baseline to three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale
Time Frame: Change from baseline to three months
|
It assess the pain.
|
Change from baseline to three months
|
|
5 times sit and stand test
Time Frame: Change from baseline to three months
|
It assess the functional status, muscle strength an endurance.
|
Change from baseline to three months
|
|
6-Item Self-Efficacy Scale for Managing Chronic Diseases
Time Frame: Change from baseline to three months
|
It assess the self-efficacy in patients with chronic diseases.
|
Change from baseline to three months
|
|
The Juvenile Arthritis Biopsychosocial and Clinical Questionnaire -JAB-Q
Time Frame: Change from baseline to three months
|
It assess the biopsychosocial status in JIA patients.
|
Change from baseline to three months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bilge Basakci Calik, Prof. Dr., Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PamukkaleUni.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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