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

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05837247

Collaborator

(none)

Enrollment

Location

Arms

5.3

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise Therapy Juvenile Idiopathic Arthritis	Other: Game-based home exercises Other: offline asynchronous physiotherapy	N/A

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.

In this study, the participants will be evaluated and training game-based exercises at the baseline examination. Then, the participants will be divided into two groups. Group 1 will be followed the online synchronous communication application-based telemonitoring method and Group 2 will be followed the offline asynchronous physiotherapy application-based telemonitoring method. After the game-based home exercises intervention, the groups will be re-evaluated again and the results will be compared in the groups and between the groups.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Telemonitoring-supported Game-based Home Exercises on Kinesiophobia, Pain and Quality of Life in Juvenile Idiopathic Arthritis

Actual Study Start Date :

Mar 24, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: online synchronous communication application-based telemonitoring group 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.	Other: Game-based home 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.
Active Comparator: offline asynchronous physiotherapy application-based telemonitoring group The telemonitoring-supported program will be conducted with a smartphone application. The game-based home exercises will be shared with the participants by a smartphone application. The participants will be monitored by the investigators using a physiotherapy application asynchronously.	Other: offline asynchronous physiotherapy offline asynchronous physiotherapy

Arm

Intervention/Treatment

Active Comparator: online synchronous communication application-based telemonitoring group

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.

Other: Game-based home 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.

Active Comparator: offline asynchronous physiotherapy application-based telemonitoring group

The telemonitoring-supported program will be conducted with a smartphone application. The game-based home exercises will be shared with the participants by a smartphone application. The participants will be monitored by the investigators using a physiotherapy application asynchronously.

Other: offline asynchronous physiotherapy

offline asynchronous physiotherapy

Outcome Measures

Primary Outcome Measures

The Wong-Baker Faces Pain Rating Scale [immediately After intervention]
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.
Pediatric Quality of Life Inventory (PedsQL) 3.0 Arthritis Module [immediately After intervention]
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
The Tampa Scale for Kinesiophobia [immediately After intervention]
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.

Secondary Outcome Measures

10 meter walk test [immediately After intervention]
It is widely used and recommended as a measure of gait speed. It can be employed to determine functional mobility, gait. The unit of this outcome is second.
Gait speed [immediately After intervention]
When assessing many aspects of a patient's functional mobility, practitioners find gait speed to be a very useful statistic. Moreover, gait speed is frequently employed as a predictor of general health and function due to its capacity to be altered by a number of body systems. The data will be collected from video recordings that asked participants to walk at a 10-meter walkway and videos will be analyzed with Kinovea 2D movement analysis. The unit of this outcome is meter/second.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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