Edge Computing Platform for Spine Health Risk Management Based on IoT Technology

Not Applicable

Recruiting

• Conditions: Cervical Disc Herniation; Cervical Spinal Stenosis; Ossification of Posterior Longitudinal Ligament; Neckbrace Device
• Interventions: Device: Wearable Device

• Registration Number: NCT06092138
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-10-18
• Study Start: 2023-10-20
• Study First Posted: 2023-10-23
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wearable Device Group	Wearable Device	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.

Primary Outcome Measures

Name	Time	Method
neck disability index	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	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	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 Outcome Measures

Name	Time	Method
Change in muscle strength (grade)	Enrollment baseline, the third month	Change in muscle strength (grade) = Muscle strength at the third month - Muscle strength at enrollment.; Muscle strength is graded from 0 to 5, with higher grades indicating better motor function of the extremities.; Muscle strength is evaluated by experienced physicians.
Change in muscle tone (grade)	Enrollment baseline, the third month	Change in muscle tone (grade) = Muscle tone at enrollment -Muscle tone at the third month.; Muscle tone is graded into 6 grades, with higher grades indicating worse motor function of the extremities.; Muscle tone is evaluated by experienced physicians.

Trial Locations

Locations (1)

Edge Computing Platform for Spine Health Risk Management; 🇨🇳 Beijing, Beijing, China