Back to resultsEdge Computing Platform for Spine Health Risk Management Based on IoT Technology
Primary Purpose
Cervical Disc Herniation, Cervical Spinal Stenosis, Ossification of Posterior Longitudinal Ligament
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wearable Device
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Disc Herniation focused on measuring Rehabilitation, Neckbrace Device, Cervical Diesase
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Wearable Device Group
Traditional group
Arm 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.
The Traditional intervention group used traditional interventions, i.e., routine patient education, guidance on rehabilitation exercises, and tips on proper lifestyle habits.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT06092138
First Posted
September 27, 2023
Last Updated
October 18, 2023
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT06092138
Brief Title
Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
Official Title
Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation, Cervical Spinal Stenosis, Ossification of Posterior Longitudinal Ligament, Neckbrace Device
Keywords
Rehabilitation, Neckbrace Device, Cervical Diesase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wearable Device Group
Arm Type
Experimental
Arm 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.
Arm Title
Traditional group
Arm Type
No Intervention
Arm Description
The Traditional intervention group used traditional interventions, i.e., routine patient education, guidance on rehabilitation exercises, and tips on proper lifestyle habits.
Intervention Type
Device
Intervention Name(s)
Wearable Device
Intervention Description
Whether to use wearable devices.
Primary Outcome Measure Information:
Title
visual analogue scale
Description
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.
Time Frame
Enrollment baseline，the first month, the second month, the third month
Title
neck disability index
Description
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.
Time Frame
Enrollment baseline，the first month, the second month, the third month
Title
quality of life short form 12
Description
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.
Time Frame
Enrollment baseline，the first month, the second month, the third month
Secondary Outcome Measure Information:
Title
Change in muscle strength (grade)
Description
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.
Time Frame
Enrollment baseline, the third month
Title
Change in muscle tone (grade)
Description
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.
Time Frame
Enrollment baseline, the third month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanru Duan
Phone
010-13581803400
Email
duanwanru@xwhosp.org
12. IPD Sharing Statement
Learn more about this trial
Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
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