Clinical trial NCT06569030: Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis
Official title: Effect of Spinal Orthosis on Sagittal and Frontal Parameters in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
Scoliosis Brace
3D spine analysis
plantar pressure
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: EOS-imaging®
timeFrame: Change from Baseline of treatment at 3 and 6 months
measure: Spine Rotation Measurement
timeFrame: Change from Baseline of treatment at 3 and 6 months
measure: DIERS Formetric Pedoscan
timeFrame: Change from Baseline of treatment at 3 and 6 months
measure: Scoliosis Research Society (SRS-22 test)
timeFrame: Change from Baseline of treatment at 3 and 6 months
measure: Brace Questionnaire (BrQ)
timeFrame: Change from Baseline of treatment at 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Üniversitesi Maslak Hastanesi Omurga Sağlık Merkezi
Study officials:
affiliation: https://www.medipol.edu.tr/
name: Merve Yılmaz
role: STUDY_DIRECTOR
References: