Smart sensor-based responsive mattress for offloading and treating pressure sores.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pressure, stretch, moisture, and temperature readings from the patient and device sensors will be recorded, and the difference in readings with the actuation of the device will be evaluated, and iterative development of the device will be carried out based on them.
研究概览
简要总结
This is a prospective intervention trial with the hypothesis that a pixelated smart grid mattress enabled with small and large displacements for preventing the occurrence of pressure sores in bedridden patients. A prototype bed will be developed and tested and validated on healthy volunteers. The expected outcome is the demonstration of smart pixellated mattress/cushion which is programmable to offload the body at specific areas for the prevention of pressure ulcers and evaluate its performance through defined parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy ambulant volunteers.
排除标准
- •Persons disabilities or disorders affecting mobility.
- •Paraplegics/ quadriplegics
- •Persons suffering from decreased sensations anywhere on the body
- •Persons with wounds
- •Pregnant and lactating women.
结局指标
主要结局
Pressure, stretch, moisture, and temperature readings from the patient and device sensors will be recorded, and the difference in readings with the actuation of the device will be evaluated, and iterative development of the device will be carried out based on them.
时间窗: 1. Year 2 - Five live healthy subjects will be involved for 6 trial iterations. | 2. Year 3 – Five live healthy subjects will be involved for 4 trial iterations.
次要结局
未报告次要终点
研究者
Dr Joseph Thomas
Manipal Academy of Higher Education