Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Perceived brace comfort
研究概览
简要总结
Scoliosis bracing is an effective treatment method for idiopathic scoliosis, but only if worn consistently for many hours a day. Unsurprisingly, brace discomfort is a significant deterrent against treatment adherence. For decades, custom braces for idiopathic scoliosis have been fabricated using one of three materials - copolymer, polypropylene, or polyethylene. The application of the biomechanical principles behind bracing have improved over the years, but the materials have not. The investigators' goal is to expand fabrication options by testing a 3D-printed scoliosis brace with variable flexibility. The aim is to improve patients' perceived brace comfort.
After optimizing the brace design, the investigators will collect patient feedback about the design from currently braced participants. These participants understand what a standard brace feels like and will provide impactful feedback.
详细描述
After optimizing the brace design, the investigators will collect patient feedback about the design from currently braced participants. Once a participant enrolls in the study, the 3D printed brace will be made using the exact same shape as their current brace. The standard fabrication process includes the following:
- Certified orthotist completes a full evaluation
- Taking a scan of the patient's body
- Modifying, or editing, the patient's body shape using Computer-Aided-Design and applying corrective pressures against the apex of the scoliotic curve
- Carving a positive foam model of the modified shape and thermoforming the polypropylene plastic over the positive foam model
These steps were already completed to make the participant's current brace, which has been deemed acceptable by their medical team, including the PI and Dr. Timothy Borden. To reduce the number of variables present, the 3D printed brace will be made using the exact same shape as their current brace. The only difference is the fabrication technique (step 4). Instead of carving a foam mode and thermoforming, the exact brace shape will be directly 3D printed. Therefore, no additional x-rays, scans, or measurements are required from the participants. The standard fabrication process and research activities are outlined in attachment titled "Fabrication Process Outline."
Once the 3D printed brace has been fabricated, the participant will come in to be fit with the brace. A standard fitting involves trimming the brace, adding straps, heating and flaring to improve comfort, and potentially adding padding. The PI is a scoliosis bracing specialist and will be the lead orthotist during the fitting process to ensure that best practices are followed.
Following the fitting, the participant will provide test out the 3D printed brace for comfort by performing a series of tasks. The activities will include the following: sitting in a chair, picking an item up from the floor while standing, picking an item up from the floor while sitting, stepping onto a stool, jogging in place for 10s, performing the hula hoop Wii-fit game, lying down on an exam table, and donning shoes. All data collection will take place via the survey platform Qualtrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
- •Have a Cobb angle between 20-40 degrees
- •Are between ages 8-18
- •Present as Risser 2+ on x-ray
- •Currently wear a traditionally fabricated scoliosis brace
- •Have good brace adherence in current brace (self-reported to be 75% of prescribed time)
- •Be an established patient of Align Clinic and Dr. Timothy Borden
- •Speak English (survey and semi-structured interview will only be available in English)
- •Assent and receive parental consent
排除标准
- •Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis
- •Have a Cobb angle outside the range of 20-40 degrees
- •Present as Risser 0 or 1
- •Do not currently wear a traditionally fabricated scoliosis brace
- •Have poor adherence in their current brace
- •Do not speak English
- •Are not willing participate in the study
研究组 & 干预措施
3D-printed brace
Enrolled participants will be fit with a 3D printed brace. The brace will be made using the exact same shape as their current brace. The fitting procedures will also remain the same.
干预措施: 3D-printed scoliosis brace (Device)
结局指标
主要结局
Perceived brace comfort
时间窗: Comparing baseline comfort measures at enrollment (current brace) to comfort measures in 3D-printed brace at fitting (roughly 4 weeks after enrollment)
Participants will complete a series of tasks (sitting down, putting shoes on, stepping onto stool, etc.) in their current brace and in the 3D-printed scoliosis brace. Each task will be completed three times and researchers will be blinded to participant responses. A Wilcoxon signed-rank test will compare 3D printed brace comfort to baseline measures.
次要结局
- Semi-structured interview(Conducted at one-week follow-up appointment)
研究者
Megan Elizabeth Castille
Assistant Professor
Baylor College of Medicine