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

NCT ID: NCT06705673

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-02-03

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Healthy control

For the healthy control group, healthy children and adolescents without any illnesses who volunteer to participate in the study will be included.

No interventions assigned to this group

Eligibility Criteria

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

• 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

• History of trauma or surgery affecting the musculoskeletal system in the last 6 months
• Hearing or visual problems
• Acute pain for any reason

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Asya Albayrak

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilay Arman, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Asena Yekdaneh, MSc

Role: PRINCIPAL_INVESTIGATOR

Fenerbahce University

Asya Albayrak, MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Fatma Gul Demirkan, Dr

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Eğitim ve Araştırma Hastanesi

Nuray Aktay Ayaz, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Central Contacts

Nilay Arman, PhD

Role: CONTACT

nilayarman@iuc.edu.tr

+905534558707

Asena Yekdaneh, MSc

Role: CONTACT

asenayekdaneh@gmail.com

+905386594786

Other Identifiers

digitsole

Identifier Type: -

Identifier Source: org_study_id