- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06314594
the Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis
March 11, 2024 updated by: Hangzhou Medical College
the Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis Based on Transformer Learning Algorithm
Based on the risk factors affecting adolescent scoliosis found in the previous social survey, this project adopts the paradigm based on transfer learning and semi-supervised learning, and uses mathematical methods such as multiple learning methods and Transformer image classification algorithms to develop and verify the early warning model and stepped treatment model of adolescent scoliosis, and conducts cost-effect analysis.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study intends to build a standard system for the prevention and treatment of scoliosis in adolescents, do a good job in school health education and prevention and control work in school, comprehensively strengthen the construction of the prevention and control system of spondylosis, improve the ability of professionals in medical institutions, and give full play to the role of home-school-medical in the prevention and control of abnormal spinal curvature in children Firstly, relying on the investigation report, we independently develop the software platform and physical device for measuring, preventing and correcting scoliosis.
Secondly, we use a series of prevention and control advantages to change from passive to active.
Based on the Internet and big data technology, we integrate Western medicine data management and monitoring technology to establish the characteristics of the disease General disease information (personal history, family history, solar terms, climate and environment detection indicators, etc.) as one of the health management platform, the management platform set up health archives disease risk early warning health intervention and health promotion education follow-up management system management data quality control review data analysis and visualization 9 modules, respectively set up a management platform patient-side physician side and management background 3 parts through sampling investigation clinical research, break the medical school barriers, to build a personalized step treatment model for adolescent scoliosis.
Study Type
Interventional
Enrollment (Estimated)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xinyun Dr LI, Doctor
- Phone Number: 8618069783240
- Email: lxyjasmine2010@163.com
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 311000
- Recruiting
- the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
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Contact:
- Xinyun Dr LI, Doctor
- Phone Number: 8618069783240
- Email: lxyjasmine2010@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Diagnosis of moderate to mild scoliosis (Cobb angle less than 45°), age 12-16 years, male or female, no psychiatric illness, normal communication, reading and writing
Exclusion Criteria:
- Patients with a clear history of triggers, such as diseases caused by trauma, surgery, etc., cognitive dysfunction, severe heart, liver, kidney and other organ dysfunction, malignant tumors, immune diseases and other malignant diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
Conventional treatment
|
|
Experimental: intervention
Using paradigms based on transfer learning and semi-supervised learning, using multiple learning methods, transformer image classification algorithms and other mathematical methods, an early warning model and stepped treatment model for adolescent scoliosis were developed and verified, and a cost-effectiveness analysis was conducted at the same time.
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Routine medical treatment mode and routine treatment plan, observation and intervention for 4 months.
Individualized step-by-step treatment model, after screening, the results are imported into the health management platform, and the optimal plan is obtained through data calculation, which is sent to the individual (family) or school, and corresponding treatment is carried out under the guidance of the platform, and observation and intervention 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Cobb angles
Time Frame: 4 months before the intervention and 4 months after the intervention
|
X-rays were used to check the number of Cobb angles before and 4 months after the intervention to observe the improvement of scoliosis
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4 months before the intervention and 4 months after the intervention
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Accuracy of new screening modalities
Time Frame: 4 months before and after the intervention, 4 months after the end of the intervention, and 8 months after the end of the intervention
|
The new screening method "general examination + forward flexion test + scoliosis measuring instrument" was used for examination, and the data results before and 4 months after intervention were compared with the X-ray examination results to verify its accuracy.
|
4 months before and after the intervention, 4 months after the end of the intervention, and 8 months after the end of the intervention
|
Hamilton Depression Volume
Time Frame: 4 months before and after the intervention, 4 months after the end of the intervention, and 8 months after the end of the intervention
|
Depression status was rated using the Hamilton Depression Rating Scale
|
4 months before and after the intervention, 4 months after the end of the intervention, and 8 months after the end of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xinyun Dr Li, doctor, hangzhou medical colleage
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2023
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 11, 2024
First Submitted That Met QC Criteria
March 11, 2024
First Posted (Actual)
March 18, 2024
Study Record Updates
Last Update Posted (Actual)
March 18, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024KY920
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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