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

Capital Medical University

Status: Completed

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

Treatments: Device: Wearable Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06092138

XW-NS-NECKBRACE

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Wearable Device Group

Experimental group

Description:

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.

Treatment:

Device: Wearable Device

Traditional group

No Intervention group

Description:

The Traditional intervention group used traditional interventions, i.e., routine patient education, guidance on rehabilitation exercises, and tips on proper lifestyle habits.