ClinicalTrials.gg
Not yet recruitingNCT06705673Updated Nov 26, 2024

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

An observational study in Juvenile Idiopathic Arthritis (JIA), Familial Mediterranean Fever (FMF ) and Healthy Controls, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Istanbul University - Cerrahpasa · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as not yet recruiting.

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
6 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Arthritis, Juvenile by Istanbul University - Cerrahpasa — 6 open to participants now, 6 under way, none of them phase 3. Arthritis, Juvenile · Istanbul University - Cerrahpasa.

Started
2024
with 5 others
Observational
5 of 13
4 open now
Registered
9th of 13
by date

Among the 13 studies in Arthritis, Juvenile by Istanbul University - Cerrahpasa, this one is one of 6 that started in 2024, is one of 5 observational ones, and was the 9th registered.

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

Browse Arthritis, Juvenile studies →

Open to participants now

6 of the 13 studies in Arthritis, Juvenile by Istanbul University - Cerrahpasa are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 69 Arthritis, Juvenile studies recruiting now, 13 (19%) set no upper age limit and 50 (72%) stop at 75 or younger; 65 take children under 18; 11 take healthy volunteers.

This study: 6 Years to 18 Years · all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

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

Keywords

  • Juvenile Idıopathic Arthritis
  • Familial Mediterranean Fever
  • Gait profile
  • Smart Insole System
  • Gait analysis
04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Heel Strike Angle

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

    Time frame: Baseline

  2. Heel-Off Angle

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

    Time frame: Baseline

  3. Flat Foot

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

    Time frame: Baseline

  4. Step Length

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

    Time frame: Baseline

  5. Stance Duration

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

    Time frame: Baseline

  6. Percentage of swing time

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

    Time frame: Baseline

  7. Cadance

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

    Time frame: Baseline

  8. Walking speed

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

    Time frame: Baseline

  9. Double Support Time

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2024; primary completion for Jan 2025, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2024
First posted
Nov 26, 2024
StartEst.
Dec 2, 2024
Primary completionEst.
Jan 6, 2025
CompletionEst.
Feb 3, 2025
Last update
Nov 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06705673
Responsible party
Asya Albayrak (MSc, Istanbul Kent University) — Principal investigator
First posted
Nov 26, 2024
Start date
Dec 2, 2024 (estimated)
Primary completion
Jan 6, 2025 (estimated)
Completion
Feb 3, 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Nilay Arman, PhD
Contact
nilayarman@iuc.edu.tr
+905534558707
Asena Yekdaneh, MSc
Contact
asenayekdaneh@gmail.com
+905386594786
Nilay Arman, PhD
principal investigator · Istanbul University - Cerrahpasa
Asena Yekdaneh, MSc
principal investigator · Fenerbahce University
Asya Albayrak, MSc
principal investigator · Istanbul University - Cerrahpasa
Fatma Gul Demirkan, Dr
principal investigator · Kanuni Sultan Suleyman Eğitim ve Araştırma Hastanesi
Nuray Aktay Ayaz, Prof. Dr.
principal investigator · Istanbul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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