Scoliosis IdiopathicNCT06021314
Brace Efficiency and Generalized Joint Hypermobility
An observational study of Scoliosis Idiopathic and Hypermobility, Joint, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis and who use braces due to brace indication. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Hypermobility, Joint
- What is being tested?
- Brace
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Aug 2024
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants who were diagnosed with adolescent idiopathic scoliosis and planned to use a cheneau type scoliosis brace.
Who may be able to join
- Being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis.
- Having a standing posterior-anterior radiograph before and during the brace use.
- Having a curve of 20 degree and above according to the Cobb angle.
- Confirmation of participation.
Who cannot join
- Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis
The goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis and who use braces due to brace indication.
The main questions it aims to answer are:
- Does Generalized Joint Hypermobility have an effect on the amount of in-brace improvement achieved in children using braces?
- Does Generalized Joint Hypermobility have an effect on the change in the numerical variables related to scoliosis recorded in the out-brace measurement at the end of 6 months?
- Conditions
- Scoliosis Idiopathic, Hypermobility, Joint
- Being tested
- Brace
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BraceOther
Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Idiopathic Scoliosis | Not described Receives: Other: Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of in-brace scoliosis angle
"Cobb angle" will be taken as reference to determine the scoliosis angle. For Cobb angle measurement, the angle between the upper border of the upper vertebra and the lower border of the lowest vertebra will be calculated.
In order to determine change of scoliosis angle with brace use, the x-ray image taken just before starting to use the brace and the x-ray image taken while the brace is on the participant (in-brace condition) at the 4th week of brace usage will be evaluated. The difference between the two measurements will be recorded as change of in-brace scoliosis angle.
Measured: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Generalised Joint Hypermobility
A nine-degree "Beighton scale" will be used to determine the occurrence of generalized joint hypermobility. Additionally, a five-part questionnaire by Hakim and Graham will be used. Obtaining 4 or more points on Beighton scale and simultaneously at least 2 points in the ques-tionnaire by Hakim and Graham will be adopted as a criterion for generalized joint hypermobility diagnosis.
Measured: After participant being included in the study, latest at the 4th week of the brace use.
Secondary outcomes (5)
Change of in-brace vertebral rotation
The evaluation of vertebral rotation on radiographs will be made using the Raimondi method regolo (Marrapese Editore-Demi S.r.1., Rome). In roimondi method; through the offset shadow, the widths of the vertebral body are measured in millimeters. The width of each vertebra is determined on the anterior-posterior X-ray at the most narrow spot, the so called vertebral waist. The convex-sided pedicle is marked and bisected longitudinally by a line. In order to determine the pedicle offset, the distance of this bisecting line to the convexsided waist of the vertebral body is evaluated. The value of vertebral rotation is obtained by inserting the width and the pedicle offset in the Raimondi method regolo. The difference between the two measurements will be recorded as in-brace improvement at scoliosis angle.
Measured: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Change of in-brace spinal height
The distance between T1-S1 vertebral bodies in the x-ray image will be recorded in mm to determine the spinal height. The difference between the two measurements will be recorded as change of in-brace spinal height.
Measured: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Change of in-brace global cronal balance
The distance between T the midpoint of the C7 vertebra and the central sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace global cronal balance.
Measured: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Change of in-brace apical translation
The distance between the center of apical vertebra in the major curve and the sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace apical translation.
Measured: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Brace compliance
Daily usage hours and total brace usage time will be questioned retrospectively at the 4th week of brace use.
Measured: in-brace condition at the 4th week of the brace use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane School of Medicine
- Responsible party
- Principal investigator, Senay Cerezci Duygu, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021314
- Sponsor's protocol ID
- 2022-374
- Status last verified
- Aug 2024
- First submitted
- 8 Mar 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerezci-Duygu S, Yagci G, Nurdogan K, Demirkiran HG. Bracing Outcomes in Adolescent Idiopathic Scoliosis: The Role of Generalised Joint Hypermobility. J Paediatr Child Health. 2025 Sep;61(9):1423-1430. doi: 10.1111/jpc.70127. Epub 2025 Jun 26.
PubMed 40568822
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06021314
- Acronym / sponsor ID
- 2022-374
- Conditions
- Scoliosis Idiopathic, Hypermobility, Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Gulhane School of Medicine
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 1 Sep 2023 (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.
The goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis and who use braces due to brace indication.
The main questions it aims to answer are:
- Does Generalized Joint Hypermobility have an effect on the amount of in-brace improvement achieved in children using braces?
- Does Generalized Joint Hypermobility have an effect on the change in the numerical variables related to scoliosis recorded in the out-brace measurement at the end of 6 months?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Idiopathic Scoliosis | – | Other: Brace |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants who were diagnosed with adolescent idiopathic scoliosis and planned to use a cheneau type scoliosis brace.
Key inclusion criteria (4 listed)
- Being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis.
- Having a standing posterior-anterior radiograph before and during the brace use.
- Having a curve of 20 degree and above according to the Cobb angle.
- Confirmation of participation.
Key exclusion criteria (1 listed)
- Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BraceCheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis | Other | Adolescent Idiopathic Scoliosis |
Primary outcome
Change of in-brace scoliosis angle
Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
"Cobb angle" will be taken as reference to determine the scoliosis angle. For Cobb angle measurement, the angle between the upper border of the upper vertebra and the lower border of the lowest vertebra will be calculated. In order to determine change of scoliosis angle with brace use, the x-ray image taken just before starting to use the brace and the x-ray image taken while the brace is on the participant (in-brace condition) at the 4th week of brace usage will be evaluated. The difference between the two measurements will be recorded as change of in-brace scoliosis angle.
Generalised Joint Hypermobility
Time frame: After participant being included in the study, latest at the 4th week of the brace use.
A nine-degree "Beighton scale" will be used to determine the occurrence of generalized joint hypermobility. Additionally, a five-part questionnaire by Hakim and Graham will be used. Obtaining 4 or more points on Beighton scale and simultaneously at least 2 points in the ques-tionnaire by Hakim and Graham will be adopted as a criterion for generalized joint hypermobility diagnosis.
5 secondary outcomes
Change of in-brace vertebral rotation
Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Change of in-brace spinal height
Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Change of in-brace global cronal balance
Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Change of in-brace apical translation
Time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Brace compliance
Time frame: in-brace condition at the 4th week of the brace use
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 25 Feb 2025.
- Derived from this study: PubMed 40568822Cerezci-Duygu S, Yagci G, Nurdogan K, Demirkiran HG. Bracing Outcomes in Adolescent Idiopathic Scoliosis: The Role of Generalised Joint Hypermobility. J Paediatr Child Health. 2025 Sep;61(9):1423-1430. doi: 10.1111/jpc.70127. Epub 2025 Jun 26.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Idiopathic and Hypermobility, Joint, run by Baskent 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 1 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 25 Feb 2025. 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?
Change of in-brace scoliosis angle (time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use). 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?
On the ClinicalTrials.gov record for NCT06021314, which also lists 1 linked publication.
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 25 Feb 2025.