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Juvenile Idiopathic ArthritisNCT06870045

Dynamic Gait Index as a Functional Gait Assessment Measure in Children With JIA

An observational study of Juvenile Idiopathic Arthritis and Childhood Rheumatic Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Juvenile idiopathic arthritis (JIA) is one of the most common chronic rheumatic diseases seen in childhood. Pain, joint swelling and loss of function caused by inflammation significantly reduce the patients' quality of life and lead to muscle weakness, limited range of motion and gait disorders. Read more about this study

Who is it for?
Ages 8 to 16 yearsHealthy volunteers can take part
What is being tested?
Physical examination and Dynamic Gait Index
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2025to Oct 2026
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 8 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Juvenile Idiopathic Arthritis

Who may be able to join

  • Study Group;
  • Having a JIA diagnosis according to ILAR criteria between the ages of 8-16,
  • Having unilateral knee joint involvement that will affect walking
  • Being compatible, volunteer and cooperative in the study Control Group;
  • Not having any neurological or orthopedic diagnosis
  • Being between the ages of 8-16
  • Being at a mental level that can understand the commands of the person performing the evaluation

Who cannot join

  • Study Group;
  • Having an additional neurological or orthopedic diagnosis accompanying JIA and affecting treatment results,
  • Having lower extremity asymmetry or active lower extremity involvement other than the knee joint that will affect walking.
  • Control Group;
  • -Having any health problem that may affect the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gökçe Leblebici, PhD contact

+905397395718

leblebicigokce@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul University-Cerrahpasa

    Istanbul, Turkey, 34862

    Gökçe Leblebici, Phd, 05397395718, leblebicigokce@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Validity and Reliability of Dynamic Walking Index in Childhood Rheumatic Diseases

Juvenile idiopathic arthritis (JIA) is one of the most common chronic rheumatic diseases seen in childhood. Pain, joint swelling and loss of function caused by inflammation significantly reduce the patients' quality of life and lead to muscle weakness, limited range of motion and gait disorders. Although there are various clinical assessment methods, there is no functional test in the current literature that evaluates walking in children with JIA.

The Dynamic Gait Index (DGI) is a functional walking scale that evaluates walking on level ground, walking while changing speed, walking with sideways head turns, walking with vertical head turns, walking with pivot turns, walking by jumping over obstacles, going around obstacles and climbing stairs. While the DGA is widely used in the clinical assessment of walking in older adults and other pediatric patient groups, it has not yet been investigated for the assessment of walking difficulties in children with JIA. This study aimed to determine whether the DYI is a usable tool for assessing walking in children with JIA.

Being tested
Physical examination, Dynamic Gait Index
Keywords
juvenile idiopathic arthritis, gait, dynamic gait index, childhood rheumatic diseases
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical examinationOther

    The physical examination will included Timed Up and Go Test (TUG), Walking speed, Wong-Baker FACES Pain Scale, Pediatric balance scale and CHAQ (Childhood Health Assessment Questionnaire).

  • Dynamic Gait IndexOther

    The DGI, whose validity and reliability will be investigated, consists of 8 items: walking on level ground, walking with changing speed, walking with sideways head turns, walking with vertical head turns, walking with pivot turns, walking over obstacles, going around obstacles, and climbing stairs. Performance on each item is rated on a 4-point scale ranging from 0 (severe impairment) to 3 (normal walking ability without a walking aid). The total score is 24. Scores below 19 indicate a risk of falling, while scores above 22 define safe ambulation.

Study groups in NCT06870045
Study groupRoleWhat they receive
Patient groupThis group will be created with children with juvenile idiopathic arthritis.
Receives: Other: Physical examination; Other: Dynamic Gait Index
Healthy control groupThis group will be created with age matched healthy volunteers.
Receives: Other: Dynamic Gait Index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dynamic Gait Index

    The DGI consists of 8 items: walking on level ground, walking with changing speed, walking with sideways head turns, walking with vertical head turns, walking with pivot turns, walking over obstacles, going around obstacles, and climbing stairs. Performance on each item is rated on a 4-point scale ranging from 0 (severe impairment) to 3 (normal ability to walk without a walking aid). The total score is 24. Scores below 19 indicate a risk of falling, while scores above 22 describe safe ambulation.

    Measured: Baseline and after 2 weeks from the baseline evaluation

  2. Walking speed

    For the walking speed assessment, participants will be asked to walk along a 10-meter walkway at their preferred speed. Before the test, participants will be asked to walk 5 laps on the walkway and will be allowed to get used to the environment. During the walk, a video recording will be made in order to calculate the walking speed. For each participant, a video recording will be made with a camera fixed on a tripod placed laterally. During the walk, the participant's walking speed will be evaluated with the Kinovea 2D motion analysis program (Kinovea 0.8.15., GPLv2 license, 2019). Participants will be asked to walk 7 laps along the walkway, and the average data of these laps and the time taken to walk the 10-meter walkway in each lap will be recorded.

    Measured: Baseline

  3. Timed Up and Go Test

    The TUG test measures the time it takes for a person to get up from an arm-supported chair, walk 3 m, walk back to the chair, and sit down. The person walks at the preferred speed in their usual shoes with or without a walking aid. The tester remains with the participants at all times to ensure safety. Before starting the movement, the movement is demonstrated and explained to the child. The time it takes to get up from the chair and sit back in it is recorded. The test is repeated twice and the fastest score is recorded. Times less than 10 seconds are considered normal, while times greater than 14 seconds are recorded as a high risk of falling.

    Measured: Baseline

  4. Wong-Baker FACES Pain Scale

    The Wong-Baker FACES Pain Scale is a pain rating scale used to show children their pain intensity levels. On this scale, a person who feels happy indicates that they feel no pain (no pain), while a person who feels sad indicates that they feel a little or a lot of pain, Face 0 is very happy because they feel no pain. Face 10 visually represents severe pain that leads to crying. Participants will be asked to choose the face that best describes their pain from the scale before and after taping to assess pain.

    Measured: Baseline

  5. Pediatric Balance Scale

    To detect balance loss in children, the Pediatric Balance Scale, which is a modified version of the Berg balance scale and is used to assess functional balance skills in school-aged children, will be applied. The scale consists of 14 items, scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56. The Pediatric Balance Scale is designed for use in school-aged children with mild to moderate motor impairments. Pilot testing was conducted on children aged 5 to 15 years.

    Measured: Baseline

Secondary outcomes (1)
  1. Childhood Health Assessment Questionnarie

    The questionnaire consists of two different sections, the disability index and the discomfort index. The disability index consists of 8 parameters including dressing and personal care, standing up, eating, walking, hygiene, reaching out, holding and activities. All of these areas were assessed in 3 components. 1) How much difficulty they had in performing which daily functions 2) Whether they used special devices for daily functions 3) Whether they needed help from someone else in these activities were asked from each patient. There are 4 different possibilities for answers: 0 = no difficulty, 1 = with some difficulty, 2 = with great difficulty, 3 = unable. Discomfort was assessed by measuring pain with a 15 cm visual analog scale. The parents of the patients were asked to rate how much pain their child had in the past week and to give a score between 0 and 100. Similarly, they are asked to score between 0 and 100 on how much they have been affected by the disease since its onset

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start1 Feb 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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
Prospective
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06870045
Sponsor's protocol ID
dyi_jia
Status last verified
Jun 2026
First submitted
5 Mar 2025
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ozdogan H, Ruperto N, Kasapcopur O, Bakkaloglu A, Arisoy N, Ozen S, Ugurlu U, Unsal E, Melikoglu M; Paediatric Rheumatology International Trials Organisation. The Turkish version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ). Clin Exp Rheumatol. 2001 Jul-Aug;19(4 Suppl 23):S158-62.

    PubMed 11510322
  • Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.

    PubMed 17057441
  • Balsalobre-Fernandez C, Tejero-Gonzalez CM, del Campo-Vecino J, Bavaresco N. The concurrent validity and reliability of a low-cost, high-speed camera-based method for measuring the flight time of vertical jumps. J Strength Cond Res. 2014 Feb;28(2):528-33. doi: 10.1519/JSC.0b013e318299a52e.

    PubMed 23689339
  • Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9.

    PubMed 20003121
  • Williams EN, Carroll SG, Reddihough DS, Phillips BA, Galea MP. Investigation of the timed 'up & go' test in children. Dev Med Child Neurol. 2005 Aug;47(8):518-24. doi: 10.1017/s0012162205001027.

    PubMed 16108451
  • Lubetzky-Vilnai A, Jirikowic TL, McCoy SW. Investigation of the Dynamic Gait Index in children: a pilot study. Pediatr Phys Ther. 2011 Fall;23(3):268-73. doi: 10.1097/PEP.0b013e318227cd82.

    PubMed 21829122
  • Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. doi: 10.1093/ptj/77.8.812.

    PubMed 9256869
  • Jonsdottir J, Cattaneo D. Reliability and validity of the dynamic gait index in persons with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1410-5. doi: 10.1016/j.apmr.2007.08.109.

    PubMed 17964880
  • Hall CD, Herdman SJ. Reliability of clinical measures used to assess patients with peripheral vestibular disorders. J Neurol Phys Ther. 2006 Jun;30(2):74-81. doi: 10.1097/01.npt.0000282571.55673.ed.

    PubMed 16796772
  • Chiu YP, Fritz SL, Light KE, Velozo CA. Use of item response analysis to investigate measurement properties and clinical validity of data for the dynamic gait index. Phys Ther. 2006 Jun;86(6):778-87.

    PubMed 16737403
  • Herman T, Inbar-Borovsky N, Brozgol M, Giladi N, Hausdorff JM. The Dynamic Gait Index in healthy older adults: the role of stair climbing, fear of falling and gender. Gait Posture. 2009 Feb;29(2):237-41. doi: 10.1016/j.gaitpost.2008.08.013. Epub 2008 Oct 8.

    PubMed 18845439
  • Martini A. Systemic juvenile idiopathic arthritis. Autoimmun Rev. 2012 Nov;12(1):56-9. doi: 10.1016/j.autrev.2012.07.022. Epub 2012 Aug 2.

    PubMed 22884552
  • Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8.

    PubMed 17336654
  • Martini A, Lovell DJ, Albani S, Brunner HI, Hyrich KL, Thompson SD, Ruperto N. Juvenile idiopathic arthritis. Nat Rev Dis Primers. 2022 Jan 27;8(1):5. doi: 10.1038/s41572-021-00332-8.

    PubMed 35087087

Questions about this trial

What is this clinical trial studying?

An observational study of Juvenile Idiopathic Arthritis and Childhood Rheumatic Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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 Gökçe Leblebici, PhD (+905397395718, leblebicigokce@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamic Gait Index (time frame: Baseline and after 2 weeks from the baseline evaluation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06870045, which also lists 14 linked publications.

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 2 Jun 2026.

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