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Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis
Sponsor: Nippon Sigmax co., ltd.
Summary
Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate. Materials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤ 2, (3) Cobb angle between 25° and 40°, (4) age ≥ 10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.
Official title: Development and Short-Term Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis: Results From a Multicenter Prospective Observational Study of the First 60 Patients
Key Details
Gender
All
Age Range
10 Years - 15 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2019-12-24
Completion Date
2027-03
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
Spinal bracing
The semi-rigid spinal brace was developed to enhance patient compliance while maintaining effective curve correction. Patients were instructed to wear the brace for 18-20 h daily.
Locations (1)
Aizu Medical Center at Fukushima Medical University
Aizu-Wakamatsu, Fukushima, Japan