Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Instant spinal correction
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. Spinal 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; however, its efficacy is still controversial. Functional intimate apparel 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 functional intimate apparel as a treatment option for adolescents with early scoliosis.
This project aims to combine clinical experience with textiles and materials sciences to research and develop a functional intimate apparel 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 a functional intimate apparel to wear for 8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography and sonography.
详细描述
This project aims to combine clinical experience with textiles and materials sciences to research and develop a functional intimate apparel for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.
The design of functional intimate apparel will incorporate different mechanisms, such as a) compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket lining with the principle of the 3-point pressure system, d) axial rotation or coupled motion by using a system with uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure.
In this study, the eligible subjects will be given a functional intimate apparel to wear for 8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography and sonography.
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
- 是
入选标准
- •Aged 10 to 13 years
- •Diagnosis of AIS in early stage
- •Primary Cobb angle 15-35 degrees
- •Pre-menarche or post- menarche 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 functional intimate apparel 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
Instant spinal correction
时间窗: 2 hours after wearing the functional intimate apparel
Measure lateral curvature of vertebra under x-ray. The instant effectiveness of the functional intimate apparel will be evaluated through radiography.
Six-month spinal control
时间窗: 6 months
Measure the lateral curvature by Scolioscan. The changes of spinal deformity over a period of 6 months will be evaluated through the sonography.
次要结局
- Contour control(6 months)
- Interface pressure of the functional intimate apparel(2 hours after wearing the functional intimate apparel and 6 months)
- Health-related quality of life (SRS-22)(6 months)
- Back muscle activity(6 months)
- Patients' perception of self-image (TAPS)(6 months)
- Health-related quality of life (EQ-5D-5L)(6 months)
研究者
Joanne Yip
Assistant Professor
The Hong Kong Polytechnic University