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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06356350
Other study ID # IUC_jia_scoliosis_gait
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date November 1, 2024

Study information

Verified date April 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact Gökçe Leblebici, Pt, PhD
Phone 05397395718
Email leblebicigokce@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (1). These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA (2, 3). All these situations can lead to scoliosis, which we often encounter in children with JIA. Current studies describing various 3-dimension (3D) exercise methods (SEAS, Schroth, Dobomed, BSPTS, Side-shift, Lyon, etc.) effective on scoliosis (4). However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children with scoliosis diagnosed JIA.


Description:

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 (1). These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA (2, 3). All these situations can lead to scoliosis, which we often encounter in children with JIA. Current studies describing various 3-dimension (3D) exercise methods (SEAS, Schroth, Dobomed, BSPTS, Side-shift, Lyon, etc.) effective on scoliosis (4). However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children with scoliosis diagnosed JIA. Therefore, this study aimed to investigate the effects of two different exercise programs (conventional exercise program against the 3D exercises) on gait parameters in children with scoliosis diagnosed JIA. In this study, the participants will be evaluated and then they will be divided into two groups randomly. The first group will be administered as a conventional exercise group and the second one will be undergone as a 3d exercise group. After the interventions, they will be re-evaluted by the physiotherapist and the outcomes will be recorded.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Inclusion criteria was a diagnosis of JIA between the age of 8 and 16, Cobb angle > 10° and < 45° in spine X-ray, and skeletal maturity 0-4 in Risser scale. Exclusion Criteria: - Exclusion criteria were having an additional neurological or orthopedic diagnosis other than scoliosis accompanying JIA and affecting treatment results, having had any surgery on the spine, having lower extremity asymmetry, having received scoliosis treatment before, and being at a level that will not understand the questions asked.

Study Design


Intervention

Other:
Conventional exercises
Conventional exercises represent a contemporary physiotherapeutic approach incorporated into the conventional treatment of adolescent idiopathic scoliosis (AIS). Focusing on spinal stability and core strength training, these exercises aim to improve neuromuscular control, strength, and endurance in various muscles surrounding the spine, contributing to the correction and maintenance of proper posture.
3D exercises
3D 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 spinal deformities.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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. — View Citation

KISA, E. P., & OTMAN, A. S. (2020). Skolyoz odakli egzersizler-yedi büyük okulun kapsamli incelemesi. Süleyman Demirel Üniversitesi Saglik Bilimleri Dergisi, 11(2), 255-259.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ATR Angle of Trunk Rotation is the basic criterion to diagnose scoliosis. It will be evaluated using a scoliometer. The unit of the outcome is angle degree. immediately after intervention
Primary Cobb angle It is the angle that is defined as between the upper border of the upper vertebra and the lower borders of the lowest vertebra. Cobb angle will be measured using the SubrotoAngleAid application on x-ray. The unit of the outcome is angle degree. immediately after intervention
Primary 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
Primary 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
Primary 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
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