NCT06870045|Recruiting
Dynamic Gait Index as a Functional Gait Assessment Measure in Children With JIA
Investigation of Validity and Reliability of Dynamic Walking Index in Childhood Rheumatic Diseases
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Investigation of Validity and Reliability of Dynamic Walking Index in Childhood Rheumatic Diseases
Sponsor study identifier
observational
52
1 country
1
Study Start
February 1, 2025
Actual (reported)Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2025
Actual (reported)March 5, 2025
Actual (reported)March 11, 2025
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline and after 2 weeks from the baseline evaluation
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.
Baseline
Childhood Health Assessment Questionnarie
Baseline
This group will be created with children with juvenile idiopathic arthritis.
This group will be created with age matched healthy volunteers.
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).
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.
Juvenile Idiopathic Arthritis
Istanbul University-Cerrahpasa
Istanbul, Turkey, 34862, Turkey (Türkiye)
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.
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.
First Submitted
March 5, 2025
First Posted
March 11, 2025
Study Start
February 1, 2025
Actual (reported)Primary Completion
September 2026
Estimated (date passed)Immersive Virtual Reality Exergaming Program in Adolescents Diagnosed With Juvenile Idiopathic Arthritis
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.
Baseline
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.
Baseline
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.
Baseline
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 2, 2026
Record last verified: 2026-06
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