Clinical trial NCT06705673: Gait Profile and Variables in Pediatric Rheumatic Disease Using a Smart Insole System
Official title: Investigation of Gait Profile and Variables of Children and Adolescents with Pediatric Rheumatic Disease Using a Smart Insole System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Juvenile Idiopathic Arthritis (JIA)
Familial Mediterranean Fever (FMF )
Healthy Controls
Keywords: Juvenile Idıopathic Arthritis
Familial Mediterranean Fever
Gait profile
Smart Insole System
Gait analysis
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


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

Primary outcomes:
measure: Heel Strike Angle
timeFrame: Baseline
measure: Heel-Off Angle
timeFrame: Baseline
measure: Flat Foot
timeFrame: Baseline
measure: Step Length
timeFrame: Baseline
measure: Stance Duration
timeFrame: Baseline
measure: Percentage of swing time
timeFrame: Baseline
measure: Cadance
timeFrame: Baseline
measure: Walking speed
timeFrame: Baseline
measure: Double Support Time
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Nilay Arman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fenerbahce University
name: Asena Yekdaneh, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Asya Albayrak, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kanuni Sultan Suleyman Eğitim ve Araştırma Hastanesi
name: Fatma Gul Demirkan, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Nuray Aktay Ayaz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: