Safety and Efficacy of 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
- 2
- 主要终点
- Progression of the spinal curve
研究概览
简要总结
One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological concerns into consideration.
详细描述
The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials:
- axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk,
- 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining,
- pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands,
- derotation between the pelvis and shoulders with uneven straps, and
- an active mechanism with sensors added to the brace to maintain correct posture.
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 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 10 to 14 years
- •Diagnosis of AIS
- •a Cobb's angle between 20 to 30 degrees
- •a Risser grade of the iliac crest of ≤ 2
- •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
- •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: 18 months
The spinal curve is said to be under control if the increase in the Cobb's angle is \<5°
次要结局
- Posture improvement(18 months)
研究者
Joanne Yip
Professor
The Hong Kong Polytechnic University