Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- neck disability index
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Wearable Device Group
The Wearable Device Group uses wearable devices to perform rehabilitation exercises using the provided strategies. It includes the application of IoT technology to build a cloud platform combining software and hardware, using the spine sensors described in this project to collect behavioral data (it is recommended that they be worn during working hours every day for no less than 7 hours/week), and using end-to-end AI algorithms for health monitoring; the visualized data is synchronized to the spine health platform for real-time viewing and analysis by both doctors and patients. Through cell phone software and internet platform, spine health files are established to realize convenient and efficient communication between patients and professional doctors.
Intervention: Wearable Device (Device)
Traditional group
The Traditional intervention group used traditional interventions, i.e., routine patient education, guidance on rehabilitation exercises, and tips on proper lifestyle habits.
Outcomes
Primary Outcomes
neck disability index
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Change in muscle strength (grade)(Enrollment baseline, the third month)
- Change in muscle tone (grade)(Enrollment baseline, the third month)