Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Investigate the in-brace Cobb angle
研究概览
简要总结
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.
详细描述
The design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as
- compression and pulling forces through a customizable rigid brace
- lumbar flexion by using a supporting air-belt.
- three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction
- adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users
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
- •between the ages of 10-13,
- •scoliosis with a Cobb angle larger between 10 -25 degrees;
- •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 intelligent nighttime braces protocol
排除标准
- •History of previous surgical or orthotic treatment for AIS
- •Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- •Contraindications for pulmonary and/ or exercise tests
- •Psychiatric disorders
- •Recent trauma
结局指标
主要结局
Investigate the in-brace Cobb angle
时间窗: 2 hours and 6 months after wearing the brace
1. Number of Participants Maintaining Cobb Angle Stability (\<5° Increase) After Wearing the Brace for 2 Hours, as Measured by Spine X-ray (AP View).
次要结局
- Contour control(6 months)
- Force measurements and monitoring(6 months)
- Health-related quality of life (SRS-22)(6 months)
研究者
Joanne Yip
Professor
The Hong Kong Polytechnic University