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Clinical Trials in China / NCT07045337
Active, not recruiting Not applicable

Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol

NCT07045337 · tracked via the Priya Life Science China tracker
Sponsor
Chinese University of Hong Kong
Phase
Not applicable
Started
2022-01-01
Last updated
2026-10-23

Condition(s) studied

Adolescent Idiopathic Scoliosis (AIS)

Investigational drug(s) / intervention(s)

Hybrid BracingConventional fulltime Underarm Bracing

Hybrid Bracing: Hybrid Bracing includes daytime Underarm Brace(UAB) and nighttime Lateral Bending Brace(LBB)

Conventional fulltime Underarm Bracing: Conventional group includes fulltime Underarm Brace (UAB) only.

Study summary

This is a prospective randomized controlled trial investigating the therapeutic effect of the Hybrid Bracing Protocol (HyBP) over the Conventional Brace in enhancing In-brace Correction (IBC) for adolescent idiopathic scoliosis(AIS).

Eligibility

Sex
FEMALE
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Females with AIS diagnosed after detailed clinical and radiological evaluation by an experienced orthopaedic surgeon and 2. having a single lumbar or thoracolumbar curve with Cobb angle between 20° - 40° and 3. age 10 years and older when bracing is prescribed and 4. Risser 0 to 2 and 5. either pre-menarchal or less than 1 year post-menarchal and 6. with no prior treatment for scoliosis Exclusion Criteria: 1. presenting with associated musculoskeletal, neurological or other conditions possibly responsible for the curvature 2. with previous surgical or orthotic treatment or 3. physical or mental disability that prevent patients from complying with the bracing protocol

Primary outcome measure(s)

  • In-brace Correction (IBC) — From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity
    Although bracing is considered to be useful, its effectiveness hinges on various factors one of which is the in-brace curve correction, ie In-brace Correction (IBC). IBC is defined as the percentage of Cobb angle change during an X-ray with the brace fitted on the patient.

Trial sites (1)

FacilityCityRegionStatus
Prince of Wales Hospital Hong Kong China

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Other trials for the same condition

AI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis Active, not recruiting
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System Active, not recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS Recruiting
Support System Design for Adolescent Scoliosis Orthosis Wear Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07045337 on ClinicalTrials.gov ↗ ← All trials in China