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

November 25, 2024 updated by: Asya Albayrak, Istanbul University - Cerrahpasa

Investigation of Gait Profile and Variables of Children and Adolescents with 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heel Strike Angle
Time Frame: Baseline
Monopedal parameters of walking such as heel strike will be assessed with Digitsole Pro.
Baseline
Heel-Off Angle
Time Frame: Baseline
Monopedal parameters of walking such as heel-off will be assessed with Digitsole Pro.
Baseline
Flat Foot
Time Frame: Baseline
Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.
Baseline
Step Length
Time Frame: Baseline
Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.
Baseline
Stance Duration
Time Frame: Baseline
Monopedal parameters of walking such as stance duration time will be assessed with Digitsole Pro.
Baseline
Percentage of swing time
Time Frame: Baseline
Monopedal parameters of walking such as percentage of swing time will be assessed with Digitsole Pro.
Baseline
Cadance
Time Frame: Baseline
Bipedal parameters of walking such as cadance will be assessed with Digitsole Pro.
Baseline
Walking speed
Time Frame: Baseline
Bipedal parameters of walking such as walking speed (km/h) will be assessed with Digitsole Pro.
Baseline
Double Support Time
Time Frame: Baseline
Bipedal parameters of walking such as double support time will be assessed with Digitsole Pro.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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 Süleyman Eğitim ve Araştırma Hastanesi
  • Principal Investigator: Nuray Aktay Ayaz, Prof. Dr., Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • digitsole

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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