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

NCT06705673 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-11-26

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Nilay Arman, PhD · Istanbul University - Cerrahpasa

  • Asena Yekdaneh, MSc · Fenerbahce University

  • Asya Albayrak, MSc · Istanbul University - Cerrahpasa

  • Fatma Gul Demirkan, Dr · Kanuni Sultan Suleyman Eğitim ve Araştırma Hastanesi

  • Nuray Aktay Ayaz, Prof. Dr. · Istanbul University

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2025-01-06
Completion
2025-02-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06705673 on ClinicalTrials.gov