Study of Posture Correction Girdle of Adolescents With Early Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression of the spinal curve
研究概览
简要总结
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.
This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.
In this study, the eligible subjects will be given tailor-made posture correction girdles to wear it 8 hours daily. Monitoring and observation will be provided during the six months girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.
详细描述
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation.
This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.
The eligible subjects will be given tailor-made posture correction girdles. Monitoring and observation will be provided during the girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 13 Years(Child)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 10 to 13 years
- •Diagnosis of AIS in early stage
- •Primary Cobb angle equals to or less than 20 degrees
- •Pre-menarchal or post-menarchal by no more than 1 year
- •Ability to read and understand English or Chinese
- •At high risk for curve progression
- •Skeletally immature (Risser grade 0, 1, or 2)
- •Physical and mental ability to adhere to posture correction girdle protocol
排除标准
- •Contraindications for x-ray exposure
- •Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- •History of previous surgical or orthotic treatment for AIS
- •Contraindications for pulmonary and / or exercise tests
- •Psychiatric disorders
- •Recent trauma
- •Recent traumatic (emotional) event
结局指标
主要结局
Progression of the spinal curve
时间窗: From baseline to 6 months
No progression of the spinal curve (no increase of Cobb angle) by radiographic measures.
次要结局
- Progression of the spinal curve(From baseline to 6 months)
- Posture improvement(From baseline to 6 months)
研究者
Joanne Yip
Lecturer
The Hong Kong Polytechnic University
