Clinical trial Recruiting at 1 site Interventional Ages 12 to 16

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 typeInterventional
Ages12 Years to 16 Years
SexAll
Enrollment76 (estimated)
SponsorHangzhou Medical College
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedMarch 26, 2025
Main results expectedNovember 30, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 27, 2026
Trial IDNCT06314594 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.