ClinicalTrials.gov record NCT06705673

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age6 years old to 18 years old
SexAll
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study records walking (gait) features in children and adolescents with Juvenile Idiopathic Arthritis (JIA) or Familial Mediterranean Fever (FMF) and in healthy peers using the Digitsole Pro® smart insole system. Measurements are taken during a single visit (target duration 1 day). The study will compare gait variables such as angles, step length, timing and speed between patient groups and healthy controls.

What it is studying. The study is testing whether the Digitsole Pro® smart insole can measure and describe gait variables (heel angles, step length, stance and swing timing, cadence, walking speed, double support time and related measures) in children and adolescents with JIA or FMF, and how those measurements compare with healthy peers.

What the researchers hope to learn. To collect and describe objective gait measurements in children with JIA and FMF using a smart insole system, and to compare those measurements with healthy children. The study aims to build knowledge about gait differences and the use of smart insoles for gait assessment in these pediatric rheumatic conditions.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants attend a single study visit (target duration: 1 day) to wear the Digitsole Pro® smart insoles while walking. The insoles record gait measures such as heel strike and heel-off angles, flat-foot, step length, stance and percentage swing time, cadence, walking speed, and double support time. No drugs or invasive procedures are listed; the visit focuses on walking assessments and recording insole data.

How the study is structured. Observational, cross-sectional cohort study. No treatments are given. Each participant has gait recorded once with the Digitsole Pro® smart insoles; data from the JIA group, the FMF group, and healthy controls are compared.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • No sites are listed on the registry yet. Where will the study take place?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Dec 2, 2024 (estimated)
Primary completion
Jan 6, 2025 (estimated)
Study completion
Feb 3, 2025 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Nov 26, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Istanbul University - Cerrahpasa
Principal investigator
Asya Albayrak, MSc
Istanbul Kent University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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