Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Immediate in-brace correction of spinal curve
研究概览
简要总结
This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects:
- To assess the efficacy in spinal correction
- To evaluate the improvement made to the body appearance of AIS subjects
- To evaluate the impacts on the quality of life (QoL) of AIS subjects
All participants will be fitted with an Ergonomic Brace and required to wear it during the days of experiment only. The ongoing treatment with hard brace will not be substituted with the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.
详细描述
- To assess the efficacy in spinal correction
The efficacy of the Ergonomic Brace refers to the magnitude of spinal correction that could be obtained for patients with AIS. The assessments in this study focus on two aspects, which are i) the in-brace correction and ii) the interface pressure. In-brace correction is used to judge the quality of bracing and also a prognostic indicator for the long-term treatment outcome. Clinical parameters such as Cobb angle, vertebral rotation and trunk listing will be measured with radiographs by a single observer. Interface pressure in this study refers to the pressure between the brace and the trunk of subject. The purpose is to assess the time response of trunk to the intervention of the Ergonomic Brace, and correlation will also be made with the extent of spinal correction. 2. To evaluate the improvement made to the body appearance of AIS subjects
The trunk aesthetic profile of AIS subjects are being affected by spinal deformities. Surface topography of the subjects will be captured by 3D body scanner, and followed by the evaluation of body aesthetics through the trunk asymmetry scales called POTSI and ATSI index. The purpose is to compare the surface topography change before and after wearing the Ergonomic Brace. 3. To evaluate the impacts on the QoL of AIS subjects
Bracing can negatively affect the QoL of patients with AIS. The Chinese version of Brace Questionnaire (BrQ) will be adopted in this study to compare the impact of hard brace and Ergonomic Brace on the QoL of AIS subjects. Difficulties experienced by AIS subjects during bracing will be highlighted and used for future improvements in scoliosis brace design.
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
- •Age 10 or older when brace is prescribed
- •Risser 0 to 2
- •Primary curve angles 25° to 40°
- •Female, who were either pre-menarche or less than 1 year of post-menarche
- •Undergoing hard brace treatment
排除标准
- •Low risk of curve progression
- •Non-idiopathic scoliosis (e.g. congenital, neuromuscular deformities)
结局指标
主要结局
Immediate in-brace correction of spinal curve
时间窗: 2 hours
Cobb angle: more than/equal to 40% correction (lumbar/thoracolumbar curve); slightly less than/close to 40% correction (thoracic curve)
次要结局
- Immediate in-brace correction of vertebral rotation assessed by the Global Torsion Index(2 hours)
- Improvement in trunk asymmetry assessed by the ATSI index(0 and 6 month)
- Improvement in trunk asymmetry assessed by the POTSI index(0 and 6 month)
- Immediate in-brace correction of trunk listing assessed by the plumb line method(2 hours)
研究者
Joanne Yip
Assistant Professor
The Hong Kong Polytechnic University