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Clinical Trials/NCT06569030
NCT06569030
Completed
Not Applicable

Effect of Spinal Orthosis on Sagittal and Frontal Parameters in Adolescent Idiopathic Scoliosis

Istanbul Medipol University Hospital1 site in 1 country30 target enrollmentNovember 21, 2024

Overview

Phase
Not Applicable
Intervention
spinal orthoses
Conditions
Adolescent Idiopathic Scoliosis
Sponsor
Istanbul Medipol University Hospital
Enrollment
30
Locations
1
Primary Endpoint
EOS-imaging®
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 21, 2024
End Date
December 30, 2025
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

merve yılmaz

Research Assistant (Orthotist and Prosthetist)

Istanbul Medipol University Hospital

Eligibility Criteria

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

Arms & Interventions

Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis

Intervention: spinal orthoses

Outcomes

Primary Outcomes

EOS-imaging®

Time Frame: Change from Baseline of treatment at 3 and 6 months

Radiographs were 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 in the standing position. Spine and lower extremity parameters will be evaluated from the obtained image. Spine parameters; cervical lordosis ( C1C3, C2C6, C3C7), pelvic oblique, pelvic coronal obliquity angle, thoracolumbar kyphosis, lumbar lordosis, pelvic incidence, pelvic tilt, sacral slope, sagittal vertical angle, coronal vertical angle will be evaluated. Lower Extremity Parameters; hip-knee-ankle angle, medial proximal femoral angle, mechanical lateral distal femoral angle, medial proximal tibial angle, lateral distal tibial angle, lower extremity length, femur length, tibia length, recurvation angle of the knee joint will be measured.

DIERS Formetric Pedoscan

Time Frame: Change from Baseline of treatment at 3 and 6 months

Plantar Pressure and Balance Assessment It is planned to be performed with the DIERS Pedoscan device connected to the DIERS Formetric system in plantar pressure and balance assessment. DIERS Pedoscan allows the assessment of foot pressure distribution while standing. It is preferred for measuring plantar pressure changes during the individual's bipedal static stance and walking. There are static, dynamic, postural balance analysis methods in pedobarographic assessment. Numerical data is obtained for foot analysis with these methods.

Brace Questionnaire (BrQ)

Time Frame: Change from Baseline of treatment at 3 and 6 months

Evaluation of Spinal Orthosis Satisfaction Brace Questionnaire (BrQ) is a questionnaire used to measure the effect of brace treatment on quality of life in adolescent idiopathic scoliosis.

Spine Rotation Measurement

Time Frame: Change from Baseline of treatment at 3 and 6 months

Trunk Rotation Measurement: Scoliometer; is used during the person's "Adam's Forward Bend Test" to determine the trunk rotation angle.

Scoliosis Research Society (SRS-22 test)

Time Frame: Change from Baseline of treatment at 3 and 6 months

assessment of quality of life SRS-22 is a scale used to assess the quality of life in individuals with spinal deformity.

Study Sites (1)

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