Gait Profile and Variables in Pediatric Rheumatic Disease Using a Smart Insole System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Juvenile Idiopathic Arthritis (JIA), Familial Mediterranean Fever (FMF ), Healthy Controls. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of Gait Profile and Variables of Children and Adolescents with Pediatric Rheumatic Disease Using a Smart Insole System
Overview
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.
Primary outcome measures
- Heel Strike Angle [Time frame: Baseline]
- Heel-Off Angle [Time frame: Baseline]
- Flat Foot [Time frame: Baseline]
- Step Length [Time frame: Baseline]
- Stance Duration [Time frame: Baseline]
- Percentage of swing time [Time frame: Baseline]
- Cadance [Time frame: Baseline]
- Walking speed [Time frame: Baseline]
- Double Support Time [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06705673 · digitsole