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NCT Number: NCT06870045

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

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey, 34862, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gökçe Leblebici, Phd

CONTACT

[email protected]

05397395718

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

physical examination

Other

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 Index

Other

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.

Primary outcomes

  1. Dynamic Gait Index

    Time frame: Baseline and after 2 weeks from the baseline evaluation

    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.

  2. Walking speed

    Time frame: Baseline

    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.

  3. Timed Up and Go Test

    Time frame: Baseline

    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.

  4. Wong-Baker FACES Pain Scale

    Time frame: Baseline

    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.

  5. Pediatric Balance Scale

    Time frame: Baseline

    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.

Secondary outcomes

  1. Childhood Health Assessment Questionnarie

    Time frame: Baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Gökçe Leblebici, PhD

CONTACT

[email protected]

+905397395718

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Istanbul Medeniyet University
  • Medipol University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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