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Brace Efficiency and Generalized Joint Hypermobility

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06021314
Enrollment
22
Registered
2023-09-01
Start date
2023-08-01
Completion date
2024-08-01
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypermobility, Joint, Scoliosis Idiopathic

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?

Interventions

OTHERBrace

Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis

Sponsors

Gulhane School of Medicine
CollaboratorOTHER
Baskent University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change of in-brace scoliosis angleMeasurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace useCobb 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 HypermobilityAfter 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.

Secondary

MeasureTime frameDescription
Change of in-brace global cronal balanceMeasurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace useThe 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.
Change of in-brace vertebral rotationMeasurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace useThe 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.
Brace compliancein-brace condition at the 4th week of the brace useDaily usage hours and total brace usage time will be questioned retrospectively at the 4th week of brace use.
Change of in-brace apical translationMeasurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace useThe 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.
Change of in-brace spinal heightMeasurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace useThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026