Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effectiveness of posture correction girdle
研究概览
简要总结
Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spine curvature increases in youths as puberty progresses. Generally, only observation is suggested for adolescents with early scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. Flexible brace treatment is an alternative option; however, its efficacy is still controversial. Posture correction girdle with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. A scientific approach should be used to design and develop posture correction girdle as a treatment option for adolescents with early scoliosis.
详细描述
The design of posture correction girdle will incorporate different mechanisms, such as
- compression and pulling forces through a close fit of the intimate apparel
- lumbar flexion by using a supporting belt
- transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system
- axial rotation or coupled motion by using a system with uneven straps, and
- an active mechanism that aims to shift the trunk away from areas of pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Diagnosis of AIS
- •Cobb's angle 10˚-20˚
- •Risser grade ≤ 2
- •No prior treatment
- •Pre-menarche or post- menarche by no more than 1 year
- •Ability to read and understand English or Chinese
- •Physical and mental ability to adhere to anisotropic textile braces protocol
排除标准
- •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
Effectiveness of posture correction girdle
时间窗: 6 months
The spinal curve progression is said to be under control if the increase in the Cobb's angle is \<5°
次要结局
- Posture improvement(6 months)
研究者
Joanne Yip
Professor
The Hong Kong Polytechnic University