Clinical trial NCT05837247: Effects of Telemonitoring-supported Game-based Home Exercises in Juvenile Idiopathic Arthritis
Official title: Effects of Telemonitoring-supported Game-based Home Exercises on Kinesiophobia, Pain and Quality of Life in Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Juvenile Idiopathic Arthritis
Keywords: telemonitoring
physiotherapy
juvenile idiopathic arthritis
game-based exercises
telerehabilitation
remote methods
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: The Wong-Baker Faces Pain Rating Scale
timeFrame: immediately After intervention
measure: Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module
timeFrame: immediately After intervention
measure: The Tampa Scale for Kinesiophobia
timeFrame: immediately After intervention
measure: Hip flexion-extension range of motion
timeFrame: immediately After intervention
measure: Hip internal-external rotation range of motion
timeFrame: immediately After intervention
measure: Hip abduction/adduction range of motion
timeFrame: immediately After intervention
measure: Knee flexion and extension range of motion
timeFrame: immediately After intervention
measure: Ankle dorsi-plantar flexion range of motion
timeFrame: immediately After intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul Medeniyet University
name: Gökçe Leblebici, Phd, Pt
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.