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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorIstanbul University - Cerrahpasa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 6-18 years

Diagnosed with JIA or FMF at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic

Aged 6-18 years

Willing to participate in the study

Disqualifiers

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

Trial population

Patients diagnosed with Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF) who are being followed at the Istanbul Medical Faculty Pediatric Rheumatology Clinic will be included in the study. For the healthy control group, healthy children and adolescents without any illnesses who volunteer to participate in the study will be included.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: Juvenile Idiopathic Arthritis
Group B: Familial Mediterranean Fever
Group C: Healthy control

Trial outcomes

Primary outcomes

1

Heel Strike Angle

Monopedal parameters of walking such as heel strike will be assessed with Digitsole Pro.

Time frame
Baseline
2

Heel-Off Angle

Monopedal parameters of walking such as heel-off will be assessed with Digitsole Pro.

Time frame
Baseline
3

Flat Foot

Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.

Time frame
Baseline
4

Step Length

Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul University - Cerrahpasa

Lead sponsor

Istanbul Kent University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: