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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07040150

Enrollment

Registered

2025-06-27

Start date

2019-12-24

Completion date

2027-03-31

Last updated

2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis (AIS)

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.

Interventions

DEVICESpinal 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Wearing time	180 days from registration

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026