NCT05837247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

March 29, 2023

Last Update Submit

November 13, 2024

Conditions

Keywords

telemonitoringphysiotherapyjuvenile idiopathic arthritisgame-based exercisestelerehabilitationremote methods

Outcome Measures

Primary Outcomes (8)

  • 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.

    immediately After intervention

  • 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

    immediately After intervention

  • 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.

    immediately After intervention

  • 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.

    immediately After intervention

  • 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.

    immediately After intervention

  • 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.

    immediately After intervention

  • 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.

    immediately After intervention

  • 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.

    immediately After intervention

Study Arms (2)

Game-based telerehabilitation exercises

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: Home exercises

Interventions

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.

Game-based telerehabilitation exercises

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

Control group

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Patients with neurological problems in addition to rheumatic diagnosis
  • Individuals who are contraindicated to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 30031492BACKGROUND
  • 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.

    PMID: 30020092BACKGROUND
  • 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.

    PMID: 18299857BACKGROUND
  • 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.

    PMID: 29567379BACKGROUND
  • 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.

    PMID: 34425842BACKGROUND
  • 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.

    PMID: 35409751BACKGROUND
  • 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.

    PMID: 35599969BACKGROUND
  • 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.

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Gökçe Leblebici, Phd, Pt

    Istanbul Medeniyet University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssistant professor

Study Record Dates

First Submitted

March 29, 2023

First Posted

May 1, 2023

Study Start

March 30, 2023

Primary Completion

December 31, 2023

Study Completion

March 1, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations