TelerehabilitationNCT06115954
Self-Management Supported Telerehabilitation in Children and Adolescents With Juvenile Idiopathic Arthritis
A study testing Self-Management Supported Telerehabilitation in people with Telerehabilitation and Juvenile Idiopathic Arthritis, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Telerehabilitation, Juvenile Idiopathic Arthritis, Self-Management
- What is being tested?
- Self-Management Supported Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University School of Physical Therapy and Rehabilitation
Denizli
About this study
Official title: The Efficacy of Telerehabilitation-Based Self-Management Supported Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Study
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.
- Being tested
- Self-Management Supported Telerehabilitation
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management Supported TelerehabilitationOther
Supporting the exercises with an internet-based environment and self-management training for Children and Adolescents with Juvenile Idiopathic Arthritis
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Telerehabilitation | Experimental | 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. Receives: Other: Self-Management Supported Telerehabilitation |
| Asynchronous Telerehabilitation | Active comparator | 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. Receives: Other: Self-Management Supported Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)
It assess the disease activity in patients with JIA.
Measured: Change from baseline to three months
Childhood Health Assessment Scale (CHAQ)
It assess the children's functional ability over the past week.
Measured: 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.
Measured: Change from baseline to three months
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-F)
It assess the fatigue in children.
Measured: Change from baseline to three months
Secondary outcomes (4)
Numeric Rating Scale
It assess the pain.
Measured: Change from baseline to three months
5 times sit and stand test
It assess the functional status, muscle strength an endurance.
Measured: Change from baseline to three months
6-Item Self-Efficacy Scale for Managing Chronic Diseases
It assess the self-efficacy in patients with chronic diseases.
Measured: Change from baseline to three months
The Juvenile Arthritis Biopsychosocial and Clinical Questionnaire -JAB-Q
It assess the biopsychosocial status in JIA patients.
Measured: Change from baseline to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start23 Dec 2022
- Primary completion30 Nov 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Cagla Balkisli, Pamukkale University
- Investigators
- Bilge Basakci Calik, Prof. Dr., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115954
- Sponsor's protocol ID
- PamukkaleUni.
- Status last verified
- Feb 2025
- First submitted
- 16 Dec 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Telerehabilitation-Based Self-Management Supported Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06115954
- Acronym / sponsor ID
- PamukkaleUni.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synchronous Telerehabilitation | Experimental | Other: Self-Management Supported TelerehabilitationOn 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 comparator | Other: Self-Management Supported TelerehabilitationSelf-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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Management Supported TelerehabilitationSupporting the exercises with an internet-based environment and self-management training for Children and Adolescents with Juvenile Idiopathic Arthritis | Other | Asynchronous Telerehabilitation, Synchronous Telerehabilitation |
Primary outcome
Juvenile Idiopathic Arthritis Disease Activity Score (JADAS)
Time frame: Change from baseline to three months
It assess the disease activity in patients with JIA.
Childhood Health Assessment Scale (CHAQ)
Time frame: Change from baseline to three months
It assess the children's functional ability over the past week.
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.
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-F)
Time frame: Change from baseline to three months
It assess the fatigue in children.
4 secondary outcomes
Numeric Rating Scale
Time frame: Change from baseline to three months
5 times sit and stand test
Time frame: Change from baseline to three months
6-Item Self-Efficacy Scale for Managing Chronic Diseases
Time frame: Change from baseline to three months
The Juvenile Arthritis Biopsychosocial and Clinical Questionnaire -JAB-Q
Time frame: Change from baseline to three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilge Basakci Calik, Prof. Dr. study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Supported Telerehabilitation in people with Telerehabilitation and Juvenile Idiopathic Arthritis, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Juvenile Idiopathic Arthritis Disease Activity Score (JADAS) (time frame: Change from baseline to three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.