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CompletedNCT05837247Updated Nov 15, 2024

Effects of Telemonitoring-supported Game-based Home Exercises in Juvenile Idiopathic Arthritis

An interventional study of Game-based telerehabilitation exercises and Home exercises in Exercise Therapy and Juvenile Idiopathic Arthritis, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study summary

In order to cope with pain, improve quality of life and prevent kinesiophobia in children with juvenile idiopathic arthritis, most of the physiotherapy approaches used so far are standard.

However, nowadays, it has been observed that participation in treatment has increased with game-based exercises instead of standard physiotherapy. In addition, remote monitoring applications made it possible to perform physiotherapy programs, which are an integral part of the treatment in children with JIA, who is difficult to reach the clinic due to reasons such school schedule and living area, through remote monitoring. This project aimed to investigate the effects of telemonitoring-supported game-based home exercise programs on pain, kinesiophobia and quality of life.

The original aspect of our project is to include telemonitoring-supported game-based home exercise programs as an alternative physiotherapy program in children with JIA. Its contribution to clinical practice is to change the perspective of physiotherapists and children on standard physiotherapy practices, to increase their motivation, and to ensure children's participation in treatment.

Read the detailed description

Juvenile rheumatic diseases are chronic diseases with a prognosis ranging from complete recovery to long-term disability. Juvenile idiopathic arthritis (JIA) is the most common rheumatologic disease in children. Pain is one of the main clinical symptoms in JIA. Due to pain, these children with rheumatic diseases avoid moving. The fear of moving because of this pain is defined as kinesiophobia. Kinesiophobia (fear of movement); It is defined as an excessive and unreasonable fear of physical action to avoid harm or re-injury. Its prevalence in chronic pain varies between 50-70%. Regular physical activity and fitness exercises can prevent kinesiophobia; Treatment includes therapeutic exercises and cognitive behavioral therapy.

In order to cope with pain, improve quality of life and prevent kinesiophobia in children with juvenile idiopathic arthritis, most of the physiotherapy approaches used so far are standard.

However, nowadays, it has been observed that participation in treatment has increased with game-based exercises instead of standard physiotherapy. In addition, remote monitoring applications made it possible to perform physiotherapy programs, which are an integral part of the treatment in children with JIA, who is difficult to reach the clinic due to reasons such school schedule and living area, through remote monitoring. This project aimed to investigate the effects of telemonitoring-supported game-based home exercise programs on pain, kinesiophobia and quality of life.

In this study, the participants will be evaluated and training game-based exercises at the baseline examination. Then, the participants will be followed the online synchronous communication application-based telemonitoring method After the game-based home exercises intervention, the participants will be re-evaluated again and the results will be compared.

02

Conditions studied

  • Exercise Therapy
  • Juvenile Idiopathic Arthritis

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Keywords

  • telemonitoring
  • physiotherapy
  • juvenile idiopathic arthritis
  • game-based exercises
  • telerehabilitation
  • remote methods
03

In context

Arthritis, Juvenile

359 studies on the registry are indexed under Arthritis, Juvenile; 95 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 229 interventional studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 693 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Whose are diagnosed with JIA at least 1 year ago
  2. Whose are aged 6-16 years
  3. Whose are having pain in lower extremity joints for more than the last 6 months
  4. Whose have stable medical treatment
  5. Whose are at a level to understand the games and perform the activities mentally

Exclusion criteria

Exclusion Criteria:

  1. Patients with neurological problems in addition to rheumatic diagnosis
  2. Individuals who are contraindicated to exercise
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Game-based telerehabilitation exercises

    The telemonitoring-supported program will be conducted with a smartphone application synchronously. The participants will be monitored by the investigators using an online communication application during exercise sessions.The sessions will be conducted to patients' individual calender via a smartphone application and a reminder from this smartphone application will send notifications to the patients.

    Other: Game-based telerehabilitation exercises

  • Active comparator
    Control group

    The control group will be evaluated and followed with home exercise program.

    Other: Home exercises

Interventions

  • OtherGame-based telerehabilitation exercises

    online Game-based home exercises are physiotherapy programs that include exercises transformed into game activities to increase the child's participation in the rehabilitation process. The exercises were planned such as; the dwarf camel game as squat exercises; the flamingo balance game as single leg balance exercises and weight-bearing activities etc. The exercise program will be conducted for 6 weeks and 3 sessions in a week.

  • OtherHome exercises

    The physiotherapist will evaluate the control group patients and monitor them using only a home exercise program.

06

What researchers measure

Primary outcomes

  1. The Wong-Baker Faces Pain Rating Scale

    A self-report tool called The Wong-Baker Faces Pain Rating Scale is used to assess how much pain kids are experiencing. It is widely acknowledged that measuring children's pain is challenging for medical professionals. This is because children express pain differently than adults due to differences in their language, communication, and developmental stages. The Wong-Baker Pain Scale has 6 faces. The first face represents a pain score of 0 and indicates "not hurt". The second face is a 2 represents the pain score and means "it hurts a little". The third face represents a pain score of 4 and "it hurts a little more" shows. The fourth face represents a pain score of 6 and indicates "it hurts more". The fifth face represents a pain score of 8. and shows that "it hurts a lot"; the sixth face represents a pain score of 10 and indicates "worst pain". The unit of this outcome is a score.

    Time frame: immediately After intervention

  2. Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module

    Patients with JIA have the Pediatric Quality of Life Inventory (PedsQL) 3.0 arthritis module. This criterion has been translated into Turkish and its validity has been demonstrated. 44 Evaluations are made about pain and suffering (four questions), daily activities (five questions), treatment (seven questions), anxiety (three questions), communication (three questions), and parent and child modules are evaluated separately. The unit of this outcome is a score. Every item is 5-point Likert scale type. Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores mean better quality of life and fewer problems or symptoms

    Time frame: immediately After intervention

  3. The Tampa Scale for Kinesiophobia

    It is a 17-item scale developed to measure the fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. A 4-point Likert scoring (1 = I strongly disagree, 4 = I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia. It is recommended to use the total score in studies. In our study, the fear of avoiding movement will be evaluated with TSK. The unit of this outcome is a score.

    Time frame: immediately After intervention

  4. Hip flexion-extension range of motion

    The pre-study and post-study hip flexion/extension passive ranges of motion (ROM) were measured by goniometric measurement.

    Time frame: immediately After intervention

  5. Hip internal-external rotation range of motion

    The pre-study and post-study hip internal-external rotation passive ranges of motion (ROM) were measured by goniometric measurement.

    Time frame: immediately After intervention

  6. Hip abduction/adduction range of motion

    The pre-study and post-study hip abduction/adduction passive ranges of motion (ROM) were measured by goniometric measurement.

    Time frame: immediately After intervention

  7. Knee flexion and extension range of motion

    The pre-study and post-study knee flexion and extension passive ranges of motion (ROM) were measured by goniometric measurement.

    Time frame: immediately After intervention

  8. Ankle dorsi-plantar flexion range of motion

    The pre-study and post-study ankle dorsi-plantar flexion passive ranges of motion (ROM) were measured by goniometric measurement.

    Time frame: immediately After intervention

07

Study locations

1 site
  • İstanbul University-Cerrahpasa
    Istanbul, 34000, Turkey (Türkiye)
08

References and documents

Publications

  • Crayne CB, Beukelman T. Juvenile Idiopathic Arthritis: Oligoarthritis and Polyarthritis. Pediatr Clin North Am. 2018 Aug;65(4):657-674. doi: 10.1016/j.pcl.2018.03.005. PubMed 30031492 ↗
  • Arman N, Tarakci E, Tarakci D, Kasapcopur O. Effects of Video Games-Based Task-Oriented Activity Training (Xbox 360 Kinect) on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):174-181. doi: 10.1097/PHM.0000000000001001. PubMed 30020092 ↗
  • Minden K, Niewerth M. [Juvenile idiopathic arthritis--clinical subgroups and classification]. Z Rheumatol. 2008 Mar;67(2):100, 102-6, 108-10. doi: 10.1007/s00393-007-0246-5. German. PubMed 18299857 ↗
  • Weermeijer JD, Meulders A. Clinimetrics: Tampa Scale for Kinesiophobia. J Physiother. 2018 Apr;64(2):126. doi: 10.1016/j.jphys.2018.01.001. Epub 2018 Mar 19. No abstract available. PubMed 29567379 ↗
  • Zaripova LN, Midgley A, Christmas SE, Beresford MW, Baildam EM, Oldershaw RA. Juvenile idiopathic arthritis: from aetiopathogenesis to therapeutic approaches. Pediatr Rheumatol Online J. 2021 Aug 23;19(1):135. doi: 10.1186/s12969-021-00629-8. PubMed 34425842 ↗
  • Grassini S. Virtual Reality Assisted Non-Pharmacological Treatments in Chronic Pain Management: A Systematic Review and Quantitative Meta-Analysis. Int J Environ Res Public Health. 2022 Mar 29;19(7):4071. doi: 10.3390/ijerph19074071. PubMed 35409751 ↗
  • Hadjiat Y, Marchand S. Virtual Reality and the Mediation of Acute and Chronic Pain in Adult and Pediatric Populations: Research Developments. Front Pain Res (Lausanne). 2022 May 6;3:840921. doi: 10.3389/fpain.2022.840921. eCollection 2022. PubMed 35599969 ↗
  • Leblebici G, Kisa EP, Tarakci E, Gunhan I, Yenici EN, Kasapcopur O. Gamified Telerehabilitation in Oligoarticular Juvenile Idiopathic Arthritis: A Randomized Controlled, Single-Blind Trial. Int J Rheum Dis. 2025 Jul;28(7):e70342. doi: 10.1111/1756-185X.70342. PubMed 40631545 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Dec 2023, 9 months.

Of 52 non-industry interventional studies with no phase under Arthritis, Juvenile, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 9 months is below that.

Counting every sponsor, half of 54 studies reached it within 12 months; a quarter within 7 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2023
First posted
May 1, 2023
StartActual
Mar 30, 2023
Primary completionActual
Dec 31, 2023
CompletionActual
Mar 1, 2024
Last update
Nov 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05837247
Responsible party
Gokce Leblebici (Asssistant professor, Istanbul University - Cerrahpasa) — Principal investigator
First posted
May 1, 2023
Start date
Mar 30, 2023
Primary completion
Dec 31, 2023
Completion
Mar 1, 2024
Last update
Nov 15, 2024

Study contacts

Gökçe Leblebici, Phd, Pt
study chair · Istanbul Medeniyet University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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