ScoliosisScoliosisNCT04664231
Spine Deformities in Juvenile Idiopathic Arthritis
An observational study of Scoliosis and Juvenile Idiopathic Arthritis, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Scoliosis, Juvenile Idiopathic Arthritis, Awareness
- How many people
- 257 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children with juvenile idiopathic arthritis
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of the Scoliosis of Children With Juvenile Idiopathic Arthritis and Awareness of the Parents Related to Scoliosis
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.
Read the detailed 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.
- Conditions
- Scoliosis, Juvenile Idiopathic Arthritis, Awareness
- Keywords
- scoliosis, Juvenile idiopathic arthritis, Awareness, spine
- Medical subject headings
- Scoliosis, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with JIA | Children with JIA coming to clinic | |
| Healthy Children | Healthy Children in the school |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2021
- Primary completion15 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Eylül Pınar KISA, Biruni University
- Investigators
- KISA, Study director, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664231
- Sponsor's protocol ID
- Pre-PHD thesis
- Acronym
- Scoliosis
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Scoliosis of Children With Juvenile Idiopathic Arthritis and Awareness of the Parents Related to Scoliosis
- ClinicalTrials.gov ID
- NCT04664231
- Acronym / sponsor ID
- Scoliosis / Pre-PHD thesis
- Conditions
- Scoliosis, Juvenile Idiopathic Arthritis, Awareness
- Keywords
- scoliosis, Juvenile idiopathic arthritis, Awareness, spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with JIA | – | –Children with JIA coming to clinic |
| Healthy Children | – | –Healthy Children in the school |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with juvenile idiopathic arthritis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assesment of angle of trunk rotation
Time frame: Baseline
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.
Radiological imaging
Time frame: Baseline
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.
1 secondary outcome
Patient awareness forms
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KISA study director
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Juvenile Idiopathic Arthritis, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of angle of trunk rotation (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.