Design of Protective Headgear for Patients Who Have Undergone a Craniectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Patient Satisfaction Survey
研究概览
简要总结
To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy
详细描述
After being given informed consent, all participants will undergo the fitting and trial of a specially designed head protection for 6 weeks. Week 1 participants will be assessed and clinical data obtained on participants condition with the head protection fitted during the same session. Participants will return after 3 weeks for review and adjustment and again at the 6 week interval where they will also be given a questionnaire to fill up regarding their use and comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible if they are 21 years or above and have had a DC >30 days, no wounds, able to understand simple commands and have a primary caregiver
排除标准
- •Exclusion criteria are patients with severe cognitive impairment, wounds, > unilateral DC, no caregiver
结局指标
主要结局
Patient Satisfaction Survey
时间窗: 6 weeks after receiving their head protection fitting
A survey to assess Satisfaction with device
次要结局
- Euro Quality of Life - 5 Dimensions (EQ-5D)(6 weeks after receiving their head protection fitting)