- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06021314
Brace Efficiency and Generalized Joint Hypermobility
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?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Senay Cerezci Duygu
- Phone Number: +905369128768
- Email: senaycerezci@gmail.com
Study Locations
-
-
Keçiören
-
Ankara, Keçiören, Turkey
- Recruiting
- Senay Cerezci Duygu
-
Contact:
- Senay Cerezci Duygu
- Phone Number: 05369128768
- Email: senaycerezci@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adolescent Idiopathic Scoliosis
|
Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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
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.
|
After participant being included in the study, latest at the 4th week of the brace use.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
Daily usage hours and total brace usage time will be questioned retrospectively at the 4th week of brace use.
|
in-brace condition at the 4th week of the brace use
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-374
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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