Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis
NCT Number: NCT06569030
Acronym: SpinalOrthosis
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adolescent Idiopathic Scoliosis
Interventions: BIOLOGICAL: spinal orthoses
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-18
Completion Date: 2026-07-21

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.

Primary Outcome Measures: 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