- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06314594
Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management Platform
The Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xinyun Dr LI, Doctor
- Phone Number: 8618069783240
- Email: lxyjasmine2010@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 311000
- Recruiting
- the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
-
Contact:
- Xinyun Dr LI, Doctor
- Phone Number: 8618069783240
- Email: lxyjasmine2010@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The diagnosis of moderate and mild AIS, with a Cobb angle measuring less than 45°;
- The age range of 12 to 16 years old;
- Participants are required to have no history of mental illness, possess normal communication skills, and be proficient in reading and writing;
- Signed informed consent by the patient or their family.
Exclusion Criteria:
Patients who fulfill any of the following conditions will be excluded a clear history of inducement, such as diseases caused by trauma, surgery, cognitive impairment, severe dysfunction of heart, liver, kidney and other organs, and malignant tumors, immune diseases and other malignant diseases.
Study Plan
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.
|
Patients will randomly assigned to routine treatment group (control group) and individualized treatment model group (intervention group).
All patients will observed and intervened for 4 months.
Patients in the control treatment group will follow the treatment plan in the 2016SOSORT guidelines
Patients will be input into the health management platform. The optimal treatment scheme will be then determined through data calculation and sent to individuals (or their families) or schools for implementation under the guidance of the platform. It is important to note that the specific treatment plan varied from person to person. Patients were observed and intervened for a period of 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
|
4 months before the intervention and 4 months after the intervention
|
|
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
Sponsor
Investigators
- Principal Investigator: Xinyun Dr Li, doctor, hangzhou medical colleage
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024KY920
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Adolescent Idiopathic Scoliosis (AIS)
-
University of Colorado, DenverRecruitingAdolescent Idiopathic Scoliosis (AIS) | Neuromuscular ScoliosisUnited States
-
University College, LondonShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University and other collaboratorsNot yet recruitingAdolescent Idiopathic Scoliosis (AIS)
-
Beni-Suef UniversityCompletedAdolescent Idiopathic Scoliosis (AIS)Egypt
-
Istituto Scientifico Italiano Colonna VertebraleActive, not recruitingAdolescent Idiopathic Scoliosis (AIS)Italy
-
National Scoliosis CenterCompletedAdolescent Idiopathic Scoliosis (AIS) | Neuromuscular Scoliosis | Juvenile Idiopathic Scoliosis | Infantile Idiopathic Scoliosis | Ealy Onset ScoliosisUnited States
-
Shanghai Jiao Tong University School of MedicineRecruitingAdolescent Idiopathic Scoliosis (AIS) | AdherenceChina
-
Ankara City Hospital BilkentCompletedAdolescent Idiopathic Scoliosis (AIS)Turkey (Türkiye)
-
Şahide Eda ArtuçNot yet recruitingAdolescent Idiopathic Scoliosis (AIS) | Exercise (EX)Turkey (Türkiye)
-
Gözde Yagci (Gür)RecruitingAdolescent Idiopathic Scoliosis (AIS)Turkey (Türkiye)
-
Jinan University GuangzhouGuangzhou Women and Children's Medical CenterActive, not recruitingAdolescent Idiopathic Scoliosis (AIS)China
Clinical Trials on Conventional treatment
-
Qinhuangdao Hospital of Traditional Chinese MedicineShandong Public Health Clinical Center; Weifang Hospital of Traditional Chinese... and other collaboratorsRecruitingCognitive Impairment | Intracerebral HemorrhageChina
-
University of AarhusGCP-unit at Aarhus University Hospital, Aarhus, Denmark; Danish Classical Homeopathy... and other collaboratorsCompleted
-
Aveiro UniversityFundação para a Ciência e a TecnologiaCompletedLower Respiratory Tract InfectionsPortugal
-
Psicofarma, S.A. De C.V.Recruiting
-
Shanghai Mental Health CenterActive, not recruitingMood Disorders in Children and AdolescentsChina
-
Riphah International UniversityCompletedOverweight | Low Back Pain, MechanicalPakistan
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCompleted
-
Aveiro UniversityRecruiting
-
Daping Hospital and the Research Institute of Surgery...RecruitingAcute Respiratory Distress Syndrome (ARDS) | Red Blood Cells(RBC)China
-
Kutahya Health Sciences UniversityRecruiting