Innovative textile braces for treating adolescent scoliosis
Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
NA · The Hong Kong Polytechnic University · NCT02589106
This study is testing new textile braces for teenagers with scoliosis to see if they can help straighten their spines and improve their overall comfort and confidence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | Female |
| Sponsor | The Hong Kong Polytechnic University (other) |
| Locations | 2 sites (Hong Kong, Guangdong and 1 other locations) |
| Trial ID | NCT02589106 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on developing anisotropic textile braces designed to treat adolescent idiopathic scoliosis (AIS) by providing a combination of rigid, semi-rigid, and flexible support. The braces aim to correct spinal deformities and reduce curve progression while addressing the aesthetic and psychological concerns of young patients. The design incorporates various mechanisms, including axial elongation, 3-point pressure, and active posture maintenance through integrated sensors. The study will evaluate the effectiveness of these braces in a controlled setting with adolescent participants.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 10 to 14 years diagnosed with adolescent idiopathic scoliosis and a Cobb's angle between 20 to 30 degrees.
Not a fit: Patients with other musculoskeletal conditions or those who have undergone previous treatments for scoliosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and acceptable non-invasive treatment option for adolescents with scoliosis.
How similar studies have performed: While there have been various approaches to scoliosis treatment, the specific use of anisotropic textile braces represents a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 10 to 14 years * Diagnosis of AIS * a Cobb's angle between 20 to 30 degrees * a Risser grade of the iliac crest of ≤ 2 * Pre-menarche or post- menarche by no more than 1 year * Ability to read and understand English or Chinese * Physical and mental ability to adhere to anisotropic textile braces protocol 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 or orthotic 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, Guangdong and 1 other locations
- The Hong Kong Polytechnic University — Hong Kong, Guangdong, China (RECRUITING)
- The Hong Kong Polytechnic University — Hong Kong, China (RECRUITING)
Study contacts
- Study coordinator: Joanne Yip, PhD
- Email: tcjyip@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.
Conditions: Scoliosis, Anisotropic Textile Braces