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

NCT07040150 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-07-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nippon Sigmax co., ltd.

    lead INDUSTRY

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-24
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040150 on ClinicalTrials.gov