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

Not yet recruiting

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

• Registration Number: NCT06705673
• Lead Sponsor: Istanbul University - Cerrahpasa

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2024-12-02
• Primary Completion: 2025-01-06
• Study Completion: 2025-02-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
Walking speed	Baseline	Bipedal parameters of walking such as walking speed (km/h) 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.
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.
Step Length	Baseline	Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.
Cadance	Baseline	Bipedal parameters of walking such as cadance will be assessed with Digitsole Pro.
Flat Foot	Baseline	Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.