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

Investigation of Gait Profile and Variables of Children and Adolescents with Pediatric Rheumatic Disease Using a Smart Insole System

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06705673

Enrollment

Registered

2024-11-26

Start date

2024-12-02

Completion date

2025-02-03

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Mediterranean Fever (FMF ), Healthy Controls, Juvenile Idiopathic Arthritis (JIA)

Keywords

Juvenile Idıopathic Arthritis, Familial Mediterranean Fever, Gait profile, Smart Insole System, Gait analysis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Heel Strike Angle	Baseline	Monopedal parameters of walking such as heel strike will be assessed with Digitsole Pro.
Heel-Off Angle	Baseline	Monopedal parameters of walking such as heel-off will be assessed with Digitsole Pro.
Flat Foot	Baseline	Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.
Step Length	Baseline	Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.
Stance Duration	Baseline	Monopedal parameters of walking such as stance duration time will be assessed with Digitsole Pro.
Percentage of swing time	Baseline	Monopedal parameters of walking such as percentage of swing time will be assessed with Digitsole Pro.
Cadance	Baseline	Bipedal parameters of walking such as cadance will be assessed with Digitsole Pro.
Double Support Time	Baseline	Bipedal parameters of walking such as double support time will be assessed with Digitsole Pro.
Walking speed	Baseline	Bipedal parameters of walking such as walking speed (km/h) will be assessed with Digitsole Pro.

Contacts

Primary ContactNilay Arman, PhD

nilayarman@iuc.edu.tr+905534558707

Backup ContactAsena Yekdaneh, MSc

asenayekdaneh@gmail.com+905386594786

Outcome results