Juvenile Idiopathic Arthritis (JIA)NCT06705673
Gait Profile and Variables in Pediatric Rheumatic Disease Using a Smart Insole System
An observational study of Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF ), run by Istanbul University - Cerrahpasa.
Trial summary
In pediatric rheumatic diseases, joint swelling, effusion, tenderness, and painful restriction of joint movement, particularly in weight-bearing joints, frequently alter walking function. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA), Familial Mediterranean Fever (FMF ), Healthy Controls
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2024to 3 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of trauma or surgery affecting the musculoskeletal system in the last 6 months
- Hearing or visual problems
- Acute pain for any reason
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- 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
- Medical subject headings
- Arthritis, Juvenile, Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Heel Strike Angle
Monopedal parameters of walking such as heel strike will be assessed with Digitsole Pro.
Measured: Baseline
Heel-Off Angle
Monopedal parameters of walking such as heel-off will be assessed with Digitsole Pro.
Measured: Baseline
Flat Foot
Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.
Measured: Baseline
Step Length
Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.
Measured: Baseline
Stance Duration
Monopedal parameters of walking such as stance duration time will be assessed with Digitsole Pro.
Measured: Baseline
Percentage of swing time
Monopedal parameters of walking such as percentage of swing time will be assessed with Digitsole Pro.
Measured: Baseline
Cadance
Bipedal parameters of walking such as cadance will be assessed with Digitsole Pro.
Measured: Baseline
Walking speed
Bipedal parameters of walking such as walking speed (km/h) will be assessed with Digitsole Pro.
Measured: Baseline
Double Support Time
Bipedal parameters of walking such as double support time will be assessed with Digitsole Pro.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start2 Dec 2024 (estimated)
- Primary completion6 Jan 2025 (estimated)
- Study completion3 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asya Albayrak, Istanbul Kent University
- Investigators
- Nilay Arman, PhD, Principal investigator, Istanbul University - CerrahpasaAsena Yekdaneh, MSc, Principal investigator, Fenerbahce UniversityAsya Albayrak, MSc, Principal investigator, Istanbul University - CerrahpasaFatma Gul Demirkan, Dr, Principal investigator, Kanuni Sultan Suleyman Eğitim ve Araştırma HastanesiNuray Aktay Ayaz, Prof. Dr., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705673
- Sponsor's protocol ID
- digitsole
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Gait Profile and Variables of Children and Adolescents with Pediatric Rheumatic Disease Using a Smart Insole System
- ClinicalTrials.gov ID
- NCT06705673
- Acronym / sponsor ID
- digitsole
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 6 Jan 2025 (estimated)
- Study completion
- 3 Feb 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- Aged 6-18 years
- Diagnosed with JIA or FMF at least 6 months ago at the Istanbul Medical Faculty Pediatric Rheumatology Clinic
- Aged 6-18 years
- Willing to participate in the study
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heel Strike Angle
Time frame: Baseline
Monopedal parameters of walking such as heel strike will be assessed with Digitsole Pro.
Heel-Off Angle
Time frame: Baseline
Monopedal parameters of walking such as heel-off will be assessed with Digitsole Pro.
Flat Foot
Time frame: Baseline
Monopedal parameters of walking such as Flat-Foot (FFI) will be assessed with Digitsole Pro.
Step Length
Time frame: Baseline
Monopedal parameters of walking such as step length in meters will be assessed with Digitsole Pro.
Stance Duration
Time frame: Baseline
Monopedal parameters of walking such as stance duration time will be assessed with Digitsole Pro.
Percentage of swing time
Time frame: Baseline
Monopedal parameters of walking such as percentage of swing time will be assessed with Digitsole Pro.
Cadance
Time frame: Baseline
Bipedal parameters of walking such as cadance will be assessed with Digitsole Pro.
Walking speed
Time frame: Baseline
Bipedal parameters of walking such as walking speed (km/h) will be assessed with Digitsole Pro.
Double Support Time
Time frame: Baseline
Bipedal parameters of walking such as double support time will be assessed with Digitsole Pro.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nilay Arman, PhD principal investigator
Istanbul University - Cerrahpasa
Asena Yekdaneh, MSc principal investigator
Fenerbahce University
Asya Albayrak, MSc principal investigator
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF ), run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilay Arman, PhD (+905534558707, nilayarman@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heel Strike Angle (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.