Intelligent nighttime brace with smart padding for treating scoliosis in adolescents
Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
This study is testing a new smart nighttime brace for teenagers with scoliosis to see if it can help correct their spine while they sleep without interfering with their daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 10 Years to 13 Years |
| Sex | Female |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05790031 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing an intelligent nighttime brace designed specifically for adolescents with idiopathic scoliosis. The brace incorporates customizable rigid components, a supporting air-belt for lumbar flexion, and a three-point pressure system to apply corrective forces while the patient sleeps. The innovative design aims to enhance compliance and effectiveness by adjusting pressure based on the user's sleeping posture. The goal is to provide a non-invasive treatment option that minimizes disruption to daily activities.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 10-13 with a Cobb angle between 10-25 degrees and no prior treatment for scoliosis.
Not a fit: Patients with a history of surgical or orthotic treatment for scoliosis or those with other musculoskeletal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of adolescent idiopathic scoliosis, potentially reducing the need for surgical interventions.
How similar studies have performed: While the efficacy of intelligent nighttime braces is still under investigation, similar approaches in scoliosis treatment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. between the ages of 10-13, 2. scoliosis with a Cobb angle larger between 10 -25 degrees; 3. No prior treatment 4. Pre-menarche or post- menarche by no more than 1 year 5. Ability to read and understand English or Chinese 6. Physical and mental ability to adhere to intelligent nighttime braces protocol Exclusion Criteria: 1. History of previous surgical or orthotic treatment for AIS 2. Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature 3. Contraindications for pulmonary and/ or exercise tests 4. Psychiatric disorders 5. Recent trauma
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, China (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: 852-27665111
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.