Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in Cobb angle
研究概览
简要总结
Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AIS diagnosis
- •Risser 0-2
- •Primary curve angles 20 degrees - 40 degrees
- •If female, either premenarchal or less than 18 months postmenarchal.
排除标准
- •Patients with a pre-existing cardiovascular condition
- •Patients with a symptom of a neurological disorder
- •Patients with any other disorder of the musculoskeletal system affecting the lower limbs
- •Pregnancy
结局指标
主要结局
Change in Cobb angle
时间窗: Baseline, 1 year, 2 years
Radiographics will be gathered and analyzed to observe changes between time points. All out-of-brace radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.
次要结局
- Treatment failure rate(Baseline, 1 year, 2 years)
- Quality of Life (QoL) - SRS-22r(Baseline, 1 year, 2 years)
- Quality of Life (QoL) - MOBI(1 year, 2 years)
- Immediate in-brace Cobb angle(5 minutes after brace fitting)
研究者
Hubert Labelle, MD
Orthopedist, researcher
St. Justine's Hospital