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

NCT ID: NCT07040150

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-24
• Study Completion Date: 2027-03-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• diagnosed AIS
• Risser sign ≤ 2
• Cobb angle between 25° and 40°
• age ≥ 10 years
• single-curve pattern (thoracic or thoracolumbar/ lumbar)
• premenarchial or less than one year post-menarche.

Exclusion Criteria

• Patients who do not meet the SRS criteria for orthosis suitability
• Patients with a history of spinal surgery

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nippon Sigmax co., ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aizu Medical Center at Fukushima Medical University

Aizu-Wakamatsu, Fukushima, Japan

Countries

Japan

References

Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2068-75; discussion 2076-7. doi: 10.1097/01.brs.0000178819.90239.d0.

Reference Type: BACKGROUND

PMID: 16166897 (View on PubMed)

Struhl K, Chen W, Hill DE, Hope IA, Oettinger MA. Constitutive and coordinately regulated transcription of yeast genes: promoter elements, positive and negative regulatory sites, and DNA binding proteins. Cold Spring Harb Symp Quant Biol. 1985;50:489-503. doi: 10.1101/sqb.1985.050.01.061. No abstract available.

Reference Type: BACKGROUND

PMID: 3913566 (View on PubMed)

Other Identifiers

AMEC brace study

Identifier Type: -

Identifier Source: org_study_id