Gait Profile and Variables in Pediatric Rheumatic Disease Using a Smart Insole System

Istanbul University - Cerrahpasa

Status: Not yet enrolling

Conditions: Familial Mediterranean Fever (FMF ); Healthy Controls; Juvenile Idiopathic Arthritis (JIA)

Study type: Observational

Funder types: Other

Identifiers

NCT06705673

digitsole

Details and patient eligibility

About

In pediatric rheumatic diseases, joint swelling, effusion, tenderness, and painful restriction of joint movement, particularly in weight-bearing joints, frequently alter walking function. These changes affect temporal and spatial parameters of gait, as well as kinematic and kinetic characteristics, leading to functional limitations. Comprehensive physical assessments in patients may not always predict changes in gait parameters. Therefore, incorporating objective methods related to gait and balance into physical evaluations is essential for functional insights and clinical decision-making, aiming to prevent adaptive mechanisms that could negatively affect gait function in the long term. In this context, smart insoles have emerged as a new tool for gait analysis, offering an alternative to high-cost, lab-based equipment. The Digitsole Pro® system can measure gait profile and variables in real-life conditions. A review of the literature reveals no studies utilizing smart insole-based gait assessments in pediatric rheumatic patients. The aim of our study is to investigate the gait profile and variables of children and adolescents with pediatric rheumatic disease using the next-generation Digitsole Pro® smart insole system, and to compare the results with those of healthy peers.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Children and adolescents with pediatric rheumatic disease:

• Aged 6-18 years
• Diagnosed with JIA or FMF at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic

Healthy children and adolescents:

• Aged 6-18 years
• Willing to participate in the study

Exclusion criteria

Exclusion criteria for children and adolescents with pediatric rheumatic disease:

• History of trauma or surgery affecting the musculoskeletal system in the last 6 months
• Presence of a chronic disease other than JIA or FMF
• Acute pain for any reason
• Visual or hearing problems
• Cognitive impairment that prevents understanding of given instructions

Exclusion criteria for healthy children and adolescents:

• History of trauma or surgery affecting the musculoskeletal system in the last 6 months
• Hearing or visual problems
• Acute pain for any reason

Trial design

60 participants in 3 patient groups

Juvenile Idiopathic Arthritis

Description:

Patients diagnosed with JIA who are being followed at the Istanbul Medical Faculty Pediatric Rheumatology Clinic will be included in the study.

Familial Mediterranean Fever

Description:

Patients diagnosed with FMF who are being followed at the Istanbul Medical Faculty Pediatric Rheumatology Clinic will be included in the study.

Healthy control

Description:

For the healthy control group, healthy children and adolescents without any illnesses who volunteer to participate in the study will be included.