NCT07040150

Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Nippon Sigmax co., ltd. · Industry
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Idiopathic Scoliosis (AIS)

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2019-12-24
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-06-27
• Last updated: 2025-07-01

Locations

1 site across 1 country: Japan