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

NCT07040150 | Active Not Recruiting

• 1 other identifier: AMEC brace study
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Wearing time

  180 days from registration

Secondary Outcomes (3)

• Initial correction rate

  Immediately after registration

• Correction rate after 180 days or more

  180 days or more from registration

• Treatment success rate

  2 years or more from registration

Interventions

Spinal bracing DEVICE

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.

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Conducted at seven medical institutions in Japan.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nippon Sigmax co., ltd.: lead

Study Sites (1)

Aizu Medical Center at Fukushima Medical University

Aizu-Wakamatsu, Fukushima, 969-3492, Japan

Location

Related Publications (2)

• 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.

  PMID: 16166897 BACKGROUND

• 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.

  PMID: 3913566 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: June 27, 2025
• Study Start: December 24, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)