Self-Management Supported Telerehabilitation in Children and Adolescents With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Investigation of the Efficacy of Self-Management Supported Telerehabilitation in Children and Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115954
• Other study ID #: PamukkaleUni.
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Pamukkale University
• Contact: Berna C Caglayan
• Phone: 0905448180827
• Email: ptcaglacaglayan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis
• Self-Management
• Telerehabilitation

Intervention

Other:
• Self-Management Supported Telerehabilitation
Supporting the exercises with an internet-based environment and self-management training for Children and Adolescents with Juvenile Idiopathic Arthritis

Locations

Country	Name	City	State
Turkey	Pamukkale University School of Physical Therapy and Rehabilitation	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)	It assess the disease activity in patients with JIA.	Change from baseline to three months
Primary	Childhood Health Assessment Scale (CHAQ)	It assess the children's functional ability over the past week.	Change from baseline to three months
Primary	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
Primary	Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-F)	It assess the fatigue in children.	Change from baseline to three months
Secondary	Numeric Rating Scale	It assess the pain.	Change from baseline to three months
Secondary	5 times sit and stand test	It assess the functional status, muscle strength an endurance.	Change from baseline to three months
Secondary	6-Item Self-Efficacy Scale for Managing Chronic Diseases	It assess the self-efficacy in patients with chronic diseases.	Change from baseline to three months
Secondary	The Juvenile Arthritis Biopsychosocial and Clinical Questionnaire -JAB-Q	It assess the biopsychosocial status in JIA patients.	Change from baseline to three months