Brace Efficiency and Generalized Joint Hypermobility
Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis
1 other identifier
observational
22
1 country
1
Brief 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. 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2023
Shorter than P25 for all trials
1 active site
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
March 8, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedFebruary 25, 2025
August 1, 2024
1 year
March 8, 2023
February 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
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
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
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
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
Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Brace compliance
in-brace condition at the 4th week of the brace use
Study Arms (1)
Adolescent Idiopathic Scoliosis
Interventions
Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis
Eligibility Criteria
Participants who were diagnosed with adolescent idiopathic scoliosis and planned to use a cheneau type scoliosis brace.
You may qualify if:
- 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.
You may not qualify if:
- Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baskent Universitylead
- Gulhane School of Medicinecollaborator
Study Sites (1)
Senay Cerezci Duygu
Ankara, Keçiören, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 40568822DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Prof.
Study Record Dates
First Submitted
March 8, 2023
First Posted
September 1, 2023
Study Start
August 1, 2023
Primary Completion
July 31, 2024
Study Completion
August 1, 2024
Last Updated
February 25, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share