NCT06356350

Brief Summary

Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

April 4, 2024

Last Update Submit

November 13, 2024

Conditions

Keywords

juvenile idiopathic arthritisgaitexercisephysiotherapy

Outcome Measures

Primary Outcomes (3)

  • Maximum Loading

    It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is per cent.

    immediately after intervention

  • Center of mass displacement

    It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome is milimeter.

    immediately after intervention

  • Walking speed

    It will be obtained using the FreeMed baropodometry platform (the FreeStep v. 1.0. 3 88 software, Sensor Medica, Guidonia Montecelio, Roma, Italy). The unit of the outcome ia meter/second.

    immediately after intervention

Study Arms (2)

Core based exercise group

ACTIVE COMPARATOR

This group will be undergone core based exercises program

Other: Core based exercises

Neuromuscular exercises group

ACTIVE COMPARATOR

This group will be undergone conventional neuromuscular exercises program

Other: Conventional neuromuscular exercises

Interventions

Conventional neuromuscular exercises represent a contemporary physiotherapeutic approach. These exercises aim to improve neuromuscular control, strength, and endurance in various muscles surrounding the included joint, contributing to the correction and maintenance of proper posture.

Neuromuscular exercises group

Core based exercises increase overall mobility, relieve pain, improve posture, and support spinal alignment. Especially important for children who are still growing is to slow or stop the progression of deformities because of the asymmetrical loading pattern.

Core based exercise group

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having a diagnosis of oligoarticular JIA
  • Being between the age of 8 and 16
  • Having included knee joint.

You may not qualify if:

  • Having an additional neurological or orthopedic diagnosis other than JIA Affecting treatment results,
  • Having had any surgery on the spine or the extremity joints
  • Being at a level that will not understand the questions asked.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • Ombrello MJ, Arthur VL, Remmers EF, Hinks A, Tachmazidou I, Grom AA, Foell D, Martini A, Gattorno M, Ozen S, Prahalad S, Zeft AS, Bohnsack JF, Ilowite NT, Mellins ED, Russo R, Len C, Hilario MO, Oliveira S, Yeung RS, Rosenberg AM, Wedderburn LR, Anton J, Haas JP, Rosen-Wolff A, Minden K, Tenbrock K, Demirkaya E, Cobb J, Baskin E, Signa S, Shuldiner E, Duerr RH, Achkar JP, Kamboh MI, Kaufman KM, Kottyan LC, Pinto D, Scherer SW, Alarcon-Riquelme ME, Docampo E, Estivill X, Gul A; British Society of Pediatric and Adolescent Rheumatology (BSPAR) Study Group, Inception Cohort of Newly Diagnosed Patients with Juvenile Idiopathic Arthritis (ICON-JIA) Study Group, Childhood Arthritis Prospective Study (CAPS) Group, Randomized Placebo Phase Study of Rilonacept in sJIA (RAPPORT) Investigators, Sparks-Childhood Arthritis Response to Medication Study (CHARMS) Group, Biologically Based Outcome Predictors in JIA (BBOP) Group; Langefeld CD, Thompson S, Zeggini E, Kastner DL, Woo P, Thomson W. Genetic architecture distinguishes systemic juvenile idiopathic arthritis from other forms of juvenile idiopathic arthritis: clinical and therapeutic implications. Ann Rheum Dis. 2017 May;76(5):906-913. doi: 10.1136/annrheumdis-2016-210324. Epub 2016 Dec 7.

    PMID: 27927641BACKGROUND
  • Tokuda K, Anan M, Takahashi M, Sawada T, Tanimoto K, Kito N, Shinkoda K. Biomechanical mechanism of lateral trunk lean gait for knee osteoarthritis patients. J Biomech. 2018 Jan 3;66:10-17. doi: 10.1016/j.jbiomech.2017.10.016. Epub 2017 Nov 4.

    PMID: 29150344BACKGROUND
  • Ringold S, Wallace CA, Rivara FP. Health-related quality of life, physical function, fatigue, and disease activity in children with established polyarticular juvenile idiopathic arthritis. J Rheumatol. 2009 Jun;36(6):1330-6. doi: 10.3899/jrheum.081028. Epub 2009 May 1.

    PMID: 19411394BACKGROUND
  • KISA, E. P., & OTMAN, A. S. (2020). Skolyoz odaklı egzersizler-yedi büyük okulun kapsamlı incelemesi. Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi, 11(2), 255-259.

    BACKGROUND
  • Horng J, Liu XC, Thometz J, Tassone C, Duey-Holtz A. Evaluation of plantar pressures and center of pressure trajectories in Adolescent Idiopathic Scoliosis. Stud Health Technol Inform. 2021 Jun 28;280:131-135. doi: 10.3233/SHTI210451.

    PMID: 34190074BACKGROUND
  • Gao CC, Chern JS, Chang CJ, Lai PL, Lung CW. Center of pressure progression patterns during level walking in adolescents with idiopathic scoliosis. PLoS One. 2019 Apr 22;14(4):e0212161. doi: 10.1371/journal.pone.0212161. eCollection 2019.

    PMID: 31009471BACKGROUND
  • Zhu F, Hong Q, Guo X, Wang D, Chen J, Zhu Q, Zhang C, Chen W, Zhang M. A comparison of foot posture and walking performance in patients with mild, moderate, and severe adolescent idiopathic scoliosis. PLoS One. 2021 May 17;16(5):e0251592. doi: 10.1371/journal.pone.0251592. eCollection 2021.

    PMID: 33999943BACKGROUND

MeSH Terms

Conditions

Arthritis, JuvenileGait Disorders, NeurologicMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

April 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 10, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations