Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Orthotist Adjustment Questionnaire
研究概览
简要总结
The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace.
Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.
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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of Adolescent Idiopathic Scoliosis
- •Risser 0-2
- •Cobb Angle between 20 and 40 degrees
- •Prescription for a brace
- •Able to understand French or English
排除标准
- •Grade II or higher Spondylolisthesis
- •Neuromuscular disease
- •Past spinal surgery
结局指标
主要结局
Orthotist Adjustment Questionnaire
时间窗: 30 minutes
Questionnaire given to the orthotist after the testing period. Data about the number of adjustment and his experience working with the brace will be recorded.
Participant Questionnaire
时间窗: 30 minutes
Questionnaire given to the participant after the testing period. Data about the experience, impressions about the brace and the comfort will be recorded.
次要结局
未报告次要终点
研究者
Hubert Labelle, MD
Orthopeadic Surgeon
St. Justine's Hospital