Monitoring pressure for scoliosis brace treatment
Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
This study is testing a new way to measure pressure from a scoliosis brace on teenagers to see if it can help improve comfort and treatment results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 10 Years to 15 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Tsim Sha Tsui, Kolwoon) |
| Trial ID | NCT03716843 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adolescents with idiopathic scoliosis, aiming to develop a dynamic pressure monitoring system to improve brace treatment outcomes. By integrating fiber optic sensors into a specially designed undergarment, the study will measure pressure distribution and dynamics between the body and the thoraco-lumbo-sacral orthosis (TLSO) brace. The goal is to enhance understanding of how pressure affects treatment efficacy and patient comfort, ultimately leading to better compliance and outcomes. The study involves collaboration among experts in various fields, including engineering and orthopedics.
Who should consider this trial
Good fit: Ideal candidates are teenagers aged 10 to 16 diagnosed with adolescent idiopathic scoliosis and a Cobb's angle between 25 to 45 degrees.
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 significantly reduce discomfort and complications associated with brace treatment, improving adherence and treatment outcomes for adolescents with scoliosis.
How similar studies have performed: While the integration of dynamic pressure monitoring in brace treatment is a novel approach, similar studies have shown promise in improving treatment adherence and outcomes in other orthopedic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Teenagers diagnosed with adolescent idiopathic scoliosis * Cobb's angle between 25 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
Tsim Sha Tsui, Kolwoon
- The Hong Kong Polytechnic University — Tsim Sha Tsui, Kolwoon, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Joanne Yip, PhD — The Hong Kong Polytechnic University
- Study coordinator: Joanne Yip, PhD
- Email: joanne.yip@polyu.edu.hk
- Phone: 852-27664848
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.