Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis

NCT ID: NCT06569030

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2025-12-30

Brief Summary

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It has been observed that there are insufficient studies on whether the conservative treatment of AIS with Chêneau spinal orthosis provides 3D correction on the scoliotic curve and its effect on the spine and lower extremity parameters. The aim of this study is to investigate the effect of Chêneau spinal orthosis application on sagittal and frontal parameters at 3 and 6 months follow-up in adolescent idiopathic scoliosis.

Detailed Description

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Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine that is commonly seen in individuals aged 10-18 years, and spinal orthosis application, one of the conservative treatment methods, is widely preferred today. Lyon, Milwaukee, Gensingen, Boston and Rigo System Chêneau spinal orthoses are among the most frequently preferred today. Rigo system Chêneau (RCS) spinal orthosis aims to correct scoliosis in 3D in sagittal, transverse and coronal planes. Studies have indicated that spinal orthosis application may have limited corrective effect on sagittal and transverse planes scoliotic curvature. In order to obtain the most effective result in spinal orthosis application, it is important to fully understand the connection mechanisms between different planes and their relationship with the lower extremity. It has been observed that studies on whether conservative treatment of spinal orthosis in adolescent idiopathic scoliosis (AIS) can provide 3D correction on the scoliotic curve and its effect on spine and lower extremity parameters are insufficient. AIS individuals who will undergo Chêneau type spinal orthosis application that meets the inclusion criteria will be included in the study. Demographic information of the participants will be obtained with a patient information form and a scoliosis assessment form. Radiographs are planned to be obtained using an EOS (EOS-imaging®, Paris, France) imaging device, which is a low-dose imaging device that provides simultaneous anterior-posterior and lateral views while standing. Spine and lower extremity parameters will be evaluated from the obtained images. Plantar pressure and balance assessment is planned to be performed with a DIERS Pedoscan device connected to the DIERS Formetric system. SRS-22 (Scoliosis Research Society-22) questionnaire is planned to be used in the assessment of the quality of life of the individuals. Brace Questionnaire is planned to be used in the assessment of spinal orthosis satisfaction. All data will be evaluated by statistical analysis methods.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis

Group Type OTHER

spinal orthoses

Intervention Type BIOLOGICAL

Evaluation of scoliosis treatment in people using spinal orthoses

Interventions

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spinal orthoses

Evaluation of scoliosis treatment in people using spinal orthoses

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 10-18 years old
* Cobb angle: 15-45°
* Individuals with AIS who will be using a Chêneau type spinal orthosis for the first time • Spinal orthosis recommended for at least 18 hours per day
* Risser ≤ 3

Exclusion Criteria

* Using a foot orthosis
* Neurological problem
* Surgery history
* Lower extremity length difference greater than 1 cm
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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merve yılmaz

Research Assistant (Orthotist and Prosthetist)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Yılmaz

Role: STUDY_DIRECTOR

https://www.medipol.edu.tr/

Locations

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Acıbadem Üniversitesi Maslak Hastanesi Omurga Sağlık Merkezi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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mervearslann

Identifier Type: -

Identifier Source: org_study_id

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