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

NCT ID: NCT06092138

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wearable Device

Intervention Type: DEVICE

Whether to use wearable devices.

Traditional group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wearable Device

Whether to use wearable devices.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Edge Computing Platform for Spine Health Risk Management

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

XW-NS-NECKBRACE

Identifier Type: -

Identifier Source: org_study_id