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

Cervical Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092138
• Other study ID #: XW-NS-NECKBRACE
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: September 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Wanru Duan
• Phone: 010-13581803400
• Email: duanwanru[@]xwhosp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Cervical Spinal Stenosis
• Intervertebral Disc Displacement
• Ossification of Posterior Longitudinal Ligament
• Spinal Stenosis

Intervention

Device:
• Wearable Device
Whether to use wearable devices.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale	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.	Enrollment baseline,the first month, the second month, the third month
Primary	neck disability index	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.	Enrollment baseline,the first month, the second month, the third month
Primary	quality of life short form 12	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.	Enrollment baseline,the first month, the second month, the third month
Secondary	Change in muscle strength (grade)	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.	Enrollment baseline, the third month
Secondary	Change in muscle tone (grade)	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.	Enrollment baseline, the third month