NCT05388422已完成不适用
Physical Measurement in Patients With Severe Cerebral Palsy Using 3D Scanner and Improvement of Manufacturing Techniques for Hip Dislocation Prevention Assistive Devices
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Migration index
研究概览
简要总结
The aim of this study is to improve the manufacturing techniques of hip brace in preventing progressive hip displacement in patients with severe cerebral palsy, through the measurement of patient's physical size using a 3D scanner.
详细描述
- Design : Prospective Study
- Setting: Hospital rehabilitation department and Home
- Intervention: Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
- Main outcome measure 1) Primary outcome: right, left, both hip MI 2) Secondary outcomes: the hip and knee joint range of motion (ROM), pain intensity, satisfaction and discomfort score for the hip brace, quality of life (QOL) of the patients and their caregivers, and the wearability test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of cerebral palsy
- •age 1-15 years
- •GMFCS Level IV, V
- •quadriplegia, or diplegia for more than 6 months
- •Patients who have written consent with permission from the child and caregiver.
排除标准
- •Patients who did not agree to participate in the study
- •Patients who refused the examination
- •Patients who had hip surgery experience
- •Patients who were scheduled to undergo surgery during the clinical study
- •Patients who could not be measured with a 3D scanner
结局指标
主要结局
Migration index
时间窗: 1 weeks
Hip AP radiography
次要结局
- Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)(1 weeks)
- Likert scale (score)(1 weeks)
- Range of motion of hip joint(1 weeks)
- wearability test(1 weeks)
- Visual analog scale (Pain index)(1 weeks)
研究者
Ju Seok Ryu
Professor
Seoul National University Hospital
研究点 (2)
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