Effect of Spinal Orthosis on Sagittal and Frontal Parameters in Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EOS-imaging®
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Using a foot orthosis
- •Neurological problem
- •Surgery history
- •Lower extremity length difference greater than 1 cm
研究组 & 干预措施
Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis
干预措施: spinal orthoses (Biological)
结局指标
主要结局
EOS-imaging®
时间窗: Change from Baseline of treatment at 3 and 6 months
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.
DIERS Formetric Pedoscan
时间窗: Change from Baseline of treatment at 3 and 6 months
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.
Brace Questionnaire (BrQ)
时间窗: Change from Baseline of treatment at 3 and 6 months
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.
Spine Rotation Measurement
时间窗: Change from Baseline of treatment at 3 and 6 months
Trunk Rotation Measurement: Scoliometer; is used during the person's "Adam's Forward Bend Test" to determine the trunk rotation angle.
Scoliosis Research Society (SRS-22 test)
时间窗: Change from Baseline of treatment at 3 and 6 months
assessment of quality of life SRS-22 is a scale used to assess the quality of life in individuals with spinal deformity.
次要结局
未报告次要终点
研究者
merve yılmaz
Research Assistant (Orthotist and Prosthetist)
Istanbul Medipol University Hospital