Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569030
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Spinal Orthosis on Sagittal and Frontal Parameters in Adolescent Idiopathic Scoliosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SpinalOrthosis
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None