Flexible bracing for adolescents with idiopathic scoliosis
Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis
This study is testing new flexible braces with special features to see if they can help teenagers with scoliosis feel better and improve their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 10 Years to 15 Years |
| Sex | Female |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04116723 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of flexible braces designed with artificial hinge bones and corrective straps to treat adolescents with idiopathic scoliosis. The study employs advanced AI and machine learning techniques to develop a biomechanical computational model that recommends modifications to brace designs. Effectiveness will be assessed through low-dose X-ray radiography at various treatment stages, and a polynomial scoring system will evaluate the similarity of AI-designed braces to those created by experts. The goal is to enhance the therapeutic outcomes for patients with scoliosis.
Who should consider this trial
Good fit: Ideal candidates are teenagers diagnosed with adolescent idiopathic scoliosis, with Cobb's angles between 20 to 45 degrees and immature skeletons.
Not a fit: Patients with contraindications for x-ray exposure or those with other musculoskeletal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective non-invasive treatments for adolescents with scoliosis, potentially reducing the need for surgical interventions.
How similar studies have performed: While the use of AI and machine learning in brace design is a novel approach, traditional bracing methods have shown varying degrees of success in managing scoliosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Teenagers diagnosed with adolescent idiopathic scoliosis * Cobb's angle between 20 to 45 degrees * Immature skeletons (Risser grade 0-2) * Types of scoliosis are classified by the Lenke classification system * Have received rigid brace treatment Exclusion Criteria: * Contraindications for x-ray exposure * Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature * History of previous surgical treatment for AIS * Contraindications for pulmonary and/ or exercise tests * Psychiatric disorders * Recent trauma * Recent traumatic (emotional) event
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.