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

November 25, 2024 updated by: Asya Albayrak, Istanbul University - Cerrahpasa

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nilay Arman, PhD
Phone Number: +905534558707
Email: nilayarman@iuc.edu.tr

Study Contact Backup

Name: Asena Yekdaneh, MSc
Phone Number: +905386594786
Email: asenayekdaneh@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Juvenile Idiopathic Arthritis 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 Patients diagnosed with FMF who are being followed at the Istanbul Medical Faculty Pediatric Rheumatology Clinic will be included in the study.
Healthy control For the healthy control group, healthy children and adolescents without any illnesses who volunteer to participate in the study will be included.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Investigators

Principal Investigator: Nilay Arman, PhD, Istanbul University - Cerrahpasa
Principal Investigator: Asena Yekdaneh, MSc, Fenerbahce University
Principal Investigator: Asya Albayrak, MSc, Istanbul University - Cerrahpasa
Principal Investigator: Fatma Gul Demirkan, Dr, Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Principal Investigator: Nuray Aktay Ayaz, Prof. Dr., Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 2, 2024

Primary Completion (Estimated)

January 6, 2025

Study Completion (Estimated)

February 3, 2025

Study Registration Dates

First Submitted

November 23, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)