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

NCT06705673 | Not Yet Recruiting

• 1 other identifier: digitsole
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Heel Strike Angle

  Monopedal parameters of walking such as heel strike will be assessed with Digitsole Pro.

  Baseline

• Heel-Off Angle

  Monopedal parameters of walking such as heel-off will be assessed with Digitsole Pro.

  Baseline

• Flat Foot

  Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.

  Baseline

• Step Length

  Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.

  Baseline

• Stance Duration

  Monopedal parameters of walking such as stance duration time will be assessed with Digitsole Pro.

  Baseline

• Percentage of swing time

  Monopedal parameters of walking such as percentage of swing time will be assessed with Digitsole Pro.

  Baseline

• Cadance

  Bipedal parameters of walking such as cadance will be assessed with Digitsole Pro.

  Baseline

• Walking speed

  Bipedal parameters of walking such as walking speed (km/h) will be assessed with Digitsole Pro.

  Baseline

• Double Support Time

  Bipedal parameters of walking such as double support time will be assessed with Digitsole Pro.

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Arthritis, Juvenile; Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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 Suleyman Eğitim ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

• Nuray Aktay Ayaz, Prof. Dr.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilay Arman, PhD

CONTACT

+905534558707; nilayarman@iuc.edu.tr

Asena Yekdaneh, MSc

CONTACT

+905386594786; asenayekdaneh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: December 2, 2024
• Primary Completion: January 6, 2025
• Study Completion: February 3, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share