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Completed

NCT Number: NCT06092138

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

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.

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Key information

Conditions

Cervical Disc Herniation Bone Diseases Cervical Spinal Stenosis Musculoskeletal Diseases Neckbrace Device Ossification of Posterior Longitudinal Ligament Ossification, Heterotopic Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edge Computing Platform for Spine Health Risk Management

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

wearable device

Device

Whether to use wearable devices.

Primary outcomes

  1. visual analogue scale

    Time frame: 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.

  2. neck disability index

    Time frame: 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.

  3. quality of life short form 12

    Time frame: 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 outcomes

  1. Change in muscle strength (grade)

    Time frame: 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.

  2. Change in muscle tone (grade)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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