Individualized treatment approach for adolescent scoliosis
Official title: Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for Adolescent Idiopathic Scoliosis
Run by Hangzhou Medical College · NCT06314594 · Data updated 2026-11-12
This study is testing a new way to prevent and treat scoliosis in teenagers by using technology to create personalized treatment plans based on their specific risk factors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 16 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Hangzhou Medical College Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | March 26, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06314594 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adolescents aged 12 to 16 diagnosed with moderate to mild AIS and a Cobb angle of less than 45°.
✕Probably not a fit
Patients with severe scoliosis, cognitive impairments, or significant organ dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to develop a comprehensive prevention and treatment system for adolescent idiopathic scoliosis (AIS) by utilizing advanced mathematical methods and machine learning techniques. It focuses on creating an early warning model and a stepwise treatment model based on risk factors identified through social surveys. The study will also implement a software platform and physical devices for measuring and correcting scoliosis, integrating data management and monitoring technologies to enhance health education and intervention strategies. The goal is to shift from passive to active prevention and control of scoliosis in adolescents.
Why it matters
Potential benefit: If successful, this approach could significantly improve early detection and treatment of adolescent scoliosis, leading to better patient outcomes.
How similar studies have gone: While there have been studies on scoliosis treatment, this approach utilizing transfer learning and semi-supervised learning is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed diagnosis of mild-to-moderate Adolescent Idiopathic Scoliosis (AIS), with a Cobb angle of 10 degrees or greater and less than 45 degrees. 2. Age 12 to 16 years, targeting adolescents in the active pubertal growth phase, in whom conservative management (PSSE and bracing) is clinically prioritized. 3. Sufficient cognitive and communicative ability to understand the study procedures and use the platform. 4. Voluntary participation confirmed by signed guardian informed consent and adolescent participant assent. 5. Participants with prior conservative treatment (PSSE or bracing) are eligible provided the treatment regimen has been stable for at least 3 months prior to baseline assessment. Exclusion Criteria: 1. Secondary scoliosis caused by identifiable causes such as spinal trauma or prior spinal surgery. 2. Clinically significant severe functional impairment of heart, liver, or kidney organ function, defined as grade 3 or higher organ dysfunction according to CTCAE version 5.0. 3. Malignant tumours, autoimmune diseases, or other critical systemic illnesses that may interfere with trial outcomes. 4. Severe cognitive or psychiatric conditions, including diagnosed intellectual disability, psychotic disorders, or major depressive disorder under active psychiatric intervention, that prevent obtaining valid assent or completing study assessments.
Where it's running
-
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Xinyun Li, doctor — Hangzhou Medical College
- Study coordinator: Xinyun LI, Doctor
- Email: lxyjasmine2010@163.com
- Phone: 8618069783240
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Turkish version of the Scoliosis Misconception Scale for adolescents with AIS
This study tests a Turkish version of the Scoliosis Misconception Scale in 200 adolescents with AIS to see if the questions reliably measure misconceptions about scoliosis.
-
Hypnosis to reduce pain and nausea after scoliosis surgery in teens
Teens aged 12–18 undergoing scoliosis surgery will try preoperative hypnosis to see if it lowers pain, nausea, and opioid use after surgery.
-
Supervised vs. Home Schroth Exercises for Adolescent Idiopathic Scoliosis
This study tests whether supervised Schroth exercises work better than a home-based program for teens with AIS.
-
Sleep quality in adolescents with scoliosis
This study tests whether adolescents with idiopathic scoliosis have different sleep quality than healthy peers aged 10–18.
-
Schroth and Pilates for Adolescent Idiopathic Scoliosis
This study tests whether adding Pilates-based exercises to Schroth therapy helps teens with idiopathic scoliosis improve lung capacity, muscle strength, balance, posture, and quality of life.
-
Understanding Proteins and Skepsis Progression in Adolescent Scoliosis
Researchers will test blood protein markers to see if they can predict scoliosis progression in teens with AIS or neuromuscular scoliosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.