NCT04664231

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

November 29, 2020

Last Update Submit

February 17, 2022

Conditions

Keywords

scoliosisJuvenile idiopathic arthritisAwarenessspine

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Patient awareness forms

    Baseline

Study Arms (2)

Children with JIA

Children with JIA coming to clinic

Healthy Children

Healthy Children in the school

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children with juvenile idiopathic arthritis

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eylül Pınar Kısa

Istanbul, 34720, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ScoliosisArthritis, Juvenile

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • KISA

    Biruni University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 11, 2020

Study Start

January 1, 2021

Primary Completion

May 15, 2021

Study Completion

May 30, 2021

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations