Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis

NCT06569030 | Completed

• 1 other identifier: mervearslann
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent Idiopathic Scoliosis; Scoliosis Brace; 3D spine analysis; plantar pressure

Outcome Measures

Primary Outcomes (5)

• EOS-imaging®

  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.

  Change from Baseline of treatment at 3 and 6 months

• Spine Rotation Measurement

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

  Change from Baseline of treatment at 3 and 6 months

• DIERS Formetric Pedoscan

  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.

  Change from Baseline of treatment at 3 and 6 months

• Scoliosis Research Society (SRS-22 test)

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

  Change from Baseline of treatment at 3 and 6 months

• Brace Questionnaire (BrQ)

  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.

  Change from Baseline of treatment at 3 and 6 months

Study Arms (1)

Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis

OTHER

Biological: spinal orthoses

Interventions

spinal orthoses BIOLOGICAL

Evaluation of scoliosis treatment in people using spinal orthoses

Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Using a foot orthosis
• Neurological problem
• Surgery history
• Lower extremity length difference greater than 1 cm

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Acıbadem Üniversitesi Maslak Hastanesi Omurga Sağlık Merkezi

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Merve Yılmaz

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant (Orthotist and Prosthetist)

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 23, 2024
• Study Start: November 21, 2024
• Primary Completion: July 20, 2025
• Study Completion: December 30, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)