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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04664231
Other study ID # Pre-PHD thesis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date May 30, 2021

Study information

Verified date February 2022
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood. While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. Secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in children with JIA and to evaluate families' awareness of scoliosis.


Description:

Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood. While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. Secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in children with JIA and to evaluate families' awareness of scoliosis. aged 4-16 years will include in the study. Trunk rotation measure with scoliometer by applying forward bending test. Children with more than 5 rotations will send to the X-ray. 28 questions will asked, which evaluate the demographic characteristics of children, their educational status, their participation in sports activities, and the physical appearance of families about their children. These questions will asked if the parents had heard of scoliosis before, where they heard it, and whether anyone had scoliosis in the family. Families who complained of posture disorder will asked which shoulder is high without looking at their children and whether they see any height when they leaned forward and the pain situation in their children. Statistical analysis of the data using the SPSS 24.0 (Statistical Package for Social Sciences) program. In all analyzes, p≤0.05 consider statistically significant.


Recruitment information / eligibility

Status Completed
Enrollment 257
Est. completion date May 30, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 16 Years
Eligibility Inclusion Criteria: - Having been diagnosed with rheumatology age between 6-16, - to be diagnosed at least 6 months ago; - ability to walk independently; ability to read and write in Turkish; able to follow simple instructions - no pathology in visual ability and hearing Exclusion Criteria: - a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder); - severe musculoskeletal, neurological or cardiovascular disorders that limit mobility; - use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines - participate in scoliosis rehabilitation in the lasts 6-months.

Study Design


Locations

Country Name City State
Turkey Eylül Pinar Kisa I?stanbul

Sponsors (2)

Lead Sponsor Collaborator
Biruni University Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assesment of angle of trunk rotation Angle of trunk rotation (ATR) will be evaluated with Scoliometer.It is an easy-to-use, reliable, practical specially designed inclinometer for scoliometer. The evaluation will be done with Adam's Bend test, in the standing forward bending position. Child's feet will be positioned parallel to each other. The physiotherapist who measures to adjust the distance between the feet, by placing one foot between the two feet of the child, by moving the scoliometer from the beginning of the thoracic to the sacrum, the largest measured angle of rotation will be recorded. Baseline
Primary Radiological imaging Radiological imaging shows vertebrae' lateral tilt degree. It calculated with Cobb angle method. The Cobb angle provides information about the degree of scoliosis.i It is accepted as a clinical evaluation method used in giving information about scoliosis and determining the effectiveness of treatment and prognosis of scoliosis. Baseline
Secondary Patient awareness forms It will be created to obtain sociodemographic information and personal data about the disease. In this context, gender, age, height, weight, occupation, educational status, dominant side, affected side (s) and patient history, disease duration, time spend at the desk and sports activity will be questioned in detail. For family Scoliosis Awareness, Have you heard of scoliosis?, Is there a family?, Are the child's shoulder heights equal? (Say without looking), Which one is high? When you bend forward, do you see an asymmetry on the back?, Is there any pain? questions will ask Baseline
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