An Innovative Body-Mapping Tank Top Equipped With Biofeedback System for Adolescents With Early Scoliosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Progression of the spinal curve
研究概览
简要总结
Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature on spine. Spine curvature increases in youths as puberty progresses. The recommended treatment for AIS is different depends on the spine deformity condition. For mild scoliosis (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid plastic material restrict nearly all movements of the wearers, which caused irritation. Flexible brace is an alternative option, however, the efficiency of such treatment is questionable in terms of controlling the spine curvature progression.
Biofeedback has proven to be effective for a number of physical, psychological and psychophysical problems. The basic aim of biofeedback therapy is to support a patient in realizing his/her self-ability to control specific psychophysiological processes.
In this study, a biofeedback embedded tank-top with a specialized design for adolescents as a treatment option for AIS patients by monitoring the daily posture of the wearers.
详细描述
This project aims to combine the clinical experience with textiles and biofeedback mechanism to research and develop a biofeedback embedded tank-top for AIS. 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 biofeedback tank-top to wear it 8 hours daily. Monitor, observation and additional posture training sessions will be provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top will be evaluated by pre-and post- treatment ultrasonic imaging device (for measuring the angle of the spine), electromyography muscle signal assessment and clinical photographs assessment.
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 between 10 -20 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
Progression of the spinal curve
时间窗: From baseline to 6 months
No progression of the spinal curve (evaluated by pre-and post- treatment ultrasonic imaging device)
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
Assistant Professor
The Hong Kong Polytechnic University