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

NCT06092138 | Completed

• 1 other identifier: XW-NS-NECKBRACE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Rehabilitation; Neckbrace Device; Cervical Diesase

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Change in muscle strength (grade)

  Enrollment baseline, the third month

• Change in muscle tone (grade)

  Enrollment baseline, the third month

Study Arms (2)

Wearable Device Group

EXPERIMENTAL

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.

Device: Wearable Device

Traditional group

NO INTERVENTION

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

Interventions

Wearable Device DEVICE

Whether to use wearable devices.

Wearable Device Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Edge Computing Platform for Spine Health Risk Management

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ossification of Posterior Longitudinal Ligament

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 23, 2023
• Study Start: October 20, 2023
• Primary Completion: October 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)