Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- neck disability index
研究概览
简要总结
This project proposes to monitor the spinal posture of a person at rest and in motion in real time through a sensor device that contains spinal health monitoring as its core. By calibrating the five core planes on the spine and using AI algorithms to train the model, the relationship between the core plane data and spine health is established.This project will output medical-grade and consumer-grade wearable spine healthcare and monitoring products, establish an interactive platform to connect the wearer, the data terminal and the professional medical team, so that patients can easily get professional health advice and reminders during home healthcare and rehabilitation; and through the collection of spine health data, establish a national spine health database.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 60 years.
- •Degenerative diseases of the cervical spine such as cervical disc herniation, cervical stenosis, ossification of the posterior longitudinal ligament, etc., but surgery is not considered for the time being.
- •Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.
排除标准
- •Age less than 18 years or more than 60 years.
- •Life expectancy less than 1 year.
- •Suffering from severe dementia (MMSE score less than 18).
- •Suffering from other serious medical conditions.
- •Inability to sign informed consent.
结局指标
主要结局
neck disability index
时间窗: Enrollment baseline，the first month, the second month, the third month
The NDI consists of 10 items, including two parts: neck pain and related symptoms and activities of daily living. Each item has a minimum score of 0 and a maximum score of 5, with higher scores indicating more severe dysfunction.
visual analogue scale
时间窗: Enrollment baseline，the first month, the second month, the third month
Evaluate the efficacy of the device in reducing patients' pain. A score of 0 indicates no pain and a score of 10 represents the most severe pain that is unbearable.
quality of life short form 12
时间窗: Enrollment baseline，the first month, the second month, the third month
Evaluate the efficacy of the device in improving patients' quality of life.The maximum value of physical score is 56.58 and the maximum value of mental score is 60.76. A higher score indicates a better quality of life.
次要结局
- Change in muscle strength (grade)(Enrollment baseline, the third month)
- Change in muscle tone (grade)(Enrollment baseline, the third month)