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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06314594
Other study ID # 2024KY920
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2023
Est. completion date December 1, 2026

Study information

Verified date March 2024
Source Hangzhou Medical College
Contact Xinyun Dr LI, Doctor
Phone 8618069783240
Email lxyjasmine2010@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date December 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional treatment
Routine medical treatment mode and routine treatment plan, observation and intervention for 4 months.
Behavioral:
intervention treatment
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.

Locations

Country Name City State
China the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College. Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Hangzhou Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Cobb angles X-rays were used to check the number of Cobb angles before and 4 months after the intervention to observe the improvement of scoliosis 4 months before the intervention and 4 months after the intervention
Primary Accuracy of new screening modalities 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
Primary Hamilton Depression Volume 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
See also
  Status Clinical Trial Phase
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Completed NCT05381896 - The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis. N/A
Recruiting NCT05454800 - Effects of Physical Activity Counseling in Patients With Adolescent Idiopathic Scoliosis N/A