Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06705673

Gait Profile and Variables in 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Juvenile Idiopathic Arthritis (JIA) Arthritis Arthritis, Juvenile Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Familial Mediterranean Fever Familial Mediterranean Fever (FMF ) Genetic Diseases, Inborn Healthy Controls Hereditary Autoinflammatory Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Heel Strike Angle

    Time frame: Baseline

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

  2. Heel-Off Angle

    Time frame: Baseline

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

  3. Flat Foot

    Time frame: Baseline

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

  4. Step Length

    Time frame: Baseline

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

  5. Stance Duration

    Time frame: Baseline

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

  6. Percentage of swing time

    Time frame: Baseline

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

  7. Cadance

    Time frame: Baseline

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

  8. Walking speed

    Time frame: Baseline

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

  9. Double Support Time

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Asena Yekdaneh, MSc

CONTACT

[email protected]

+905386594786

Nilay Arman, PhD

CONTACT

[email protected]

+905534558707

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.