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Search / Trial NCT06569030

Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis

Launched by ISTANBUL MEDIPOL UNIVERSITY HOSPITAL · Aug 21, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Adolescent Idiopathic Scoliosis Scoliosis Brace 3 D Spine Analysis Plantar Pressure

ClinConnect Summary

This clinical trial is studying the effects of a special back brace called the Chêneau spinal orthosis on adolescents with a condition known as adolescent idiopathic scoliosis (AIS), which causes an abnormal curve of the spine. The researchers want to see how wearing this brace for at least 18 hours a day can help improve the shape of the spine and how it affects the body over time. The study will follow participants for three and six months to gather information on these changes.

To be eligible for this trial, participants should be between 10 and 18 years old and have a spinal curve measured by something called the Cobb angle, which should be between 15 and 45 degrees. They should also be using the Chêneau brace for the first time, and their skeletal maturity should be less than or equal to a Risser score of 3. The trial is open to anyone who meets these criteria, but those with certain conditions, like previous surgeries or significant leg length differences, cannot participate. If you or someone you know qualifies, this study could provide helpful insights into scoliosis treatment.

Gender

ALL

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

About Istanbul Medipol University Hospital

Istanbul Medipol University Hospital is a leading healthcare institution in Turkey, renowned for its commitment to advanced medical research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its state-of-the-art facilities and a multidisciplinary team of experts to facilitate innovative studies across various medical fields. With a strong emphasis on patient safety and ethical standards, Istanbul Medipol University Hospital strives to contribute to the advancement of medical knowledge and the development of effective treatments, ensuring high-quality care and improved health outcomes for patients.

Locations

Istanbul, , Turkey

Patients applied

0 patients applied

Trial Officials

Merve Yılmaz

Study Director

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported