Effect of spinal orthosis on scoliosis parameters in adolescents
Effect of Spinal Orthosis on Sagittal and Frontal Parameters in Adolescent Idiopathic Scoliosis
This study is testing whether a special back brace can help teenagers with scoliosis improve their spine shape over a few months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Istanbul Medipol University Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06569030 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Chêneau spinal orthosis on the three-dimensional correction of scoliosis in adolescents aged 10-18 years. It aims to evaluate the effects of this orthosis on sagittal and frontal parameters over a follow-up period of 3 and 6 months. Participants will undergo radiographic assessments using a low-dose EOS imaging device to analyze changes in their spinal curvature and lower extremity alignment. The study seeks to fill the gap in existing research regarding the effectiveness of conservative treatment methods for adolescent idiopathic scoliosis.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-18 years with a Cobb angle between 15-45° who are using a Chêneau spinal orthosis for the first time.
Not a fit: Patients with neurological problems, a history of surgery, or significant lower extremity length differences may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for more effective non-surgical treatment options for adolescents with scoliosis.
How similar studies have performed: While there is limited research on the specific effects of Chêneau spinal orthosis, similar studies on spinal orthoses have shown varying degrees of success in treating scoliosis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul
- Acıbadem Üniversitesi Maslak Hastanesi Omurga Sağlık Merkezi — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Merve Yılmaz
- Email: merve.yilmaz2@medipol.edu.tr
- Phone: 533 122 64 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.