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

Sponsor
Pamukkale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06115954
Collaborator
(none)
28
1
2
18.3
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Self-Management Supported Telerehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Efficacy of Self-Management Supported Telerehabilitation in Children and Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Study
Actual Study Start Date :
Nov 23, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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.

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

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.

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

Outcome Measures

Primary Outcome Measures

  1. Juvenile Idiopathic Arthritis Disease Activity Score (JADAS) [Change from baseline to three months]

    It assess the disease activity in patients with JIA.

  2. Childhood Health Assessment Scale (CHAQ) [Change from baseline to three months]

    It assess the children's functional ability over the past week.

  3. Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module [Change from baseline to three months]

    It assess the patient's quality of life in pediatric arthritis.

  4. Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-F) [Change from baseline to three months]

    It assess the fatigue in children.

Secondary Outcome Measures

  1. Numeric Rating Scale [Change from baseline to three months]

    It assess the pain.

  2. 5 times sit and stand test [Change from baseline to three months]

    It assess the functional status, muscle strength an endurance.

  3. 6-Item Self-Efficacy Scale for Managing Chronic Diseases [Change from baseline to three months]

    It assess the self-efficacy in patients with chronic diseases.

  4. The Juvenile Arthritis Biopsychosocial and Clinical Questionnaire -JAB-Q [Change from baseline to three months]

    It assess the biopsychosocial status in JIA patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pamukkale University School of Physical Therapy and Rehabilitation Denizli Turkey

Sponsors and Collaborators

  • Pamukkale University

Investigators

  • Study Director: Bilge Basakci Calik, Prof. Dr., Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Berna Cagla Caglayan, Msc. Lecturer, Specialist Physiotherapist, Pamukkale University
ClinicalTrials.gov Identifier:
NCT06115954
Other Study ID Numbers:
  • PamukkaleUni.
First Posted:
Nov 3, 2023
Last Update Posted:
Nov 3, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2023