Brace Efficiency and Generalized Joint Hypermobility

Scoliosis Idiopathic Clinical Trial

Official title:

Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021314
• Other study ID #: 2022-374
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: August 2023
• Source: Baskent University
• Contact: Senay Cerezci Duygu
• Phone: +905369128768
• Email: senaycerezci[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypermobility, Joint
• Joint Instability
• Scoliosis
• Scoliosis Idiopathic

Intervention

Other:
• Brace
Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis

Locations

Country	Name	City	State
Turkey	Senay Cerezci Duygu	Ankara	Keçiören

Sponsors (2)

Lead Sponsor	Collaborator
Baskent University	Universtiy of Health Sciences - Gülhane Faculty of Health Sciences

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Secondary	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.	Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Secondary	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.	Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Secondary	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.	Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
Secondary	Brace compliance	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