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

NCT07045337 | Active Not Recruiting DMC

• 2 other identifiers: GRF 1411972114119721
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Keywords

Adolescent Idiopathic Scoliosis; Bracing

Outcome Measures

Primary Outcomes (1)

• In-brace Correction (IBC)

  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.

  From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity

Secondary Outcomes (2)

• Curve progression

  From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity

• Quality of life questionnaires

  From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity

Study Arms (2)

Hybrid Bracing

EXPERIMENTAL

Hybrid Bracing Protocol (HyBP) combining the use of daytime Underarm Brace (UAB) and a nighttime Lateral Bending Brace

Other: Hybrid Bracing

Conventional fulltime underarm bracing (UAB)

ACTIVE COMPARATOR

Conventional group uses fulltime underarm bracing (UAB)

Other: Conventional fulltime Underarm Bracing

Interventions

Hybrid Bracing OTHER

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

Hybrid Bracing

Conventional fulltime Underarm Bracing OTHER

Conventional group includes fulltime Underarm Brace (UAB) only.

Conventional fulltime underarm bracing (UAB)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females with AIS diagnosed after detailed clinical and radiological evaluation by an experienced orthopaedic surgeon and
• having a single lumbar or thoracolumbar curve with Cobb angle between 20° - 40° and
• age 10 years and older when bracing is prescribed and
• Risser 0 to 2 and
• either pre-menarchal or less than 1 year post-menarchal and
• with no prior treatment for scoliosis

You may not qualify if:

• presenting with associated musculoskeletal, neurological or other conditions possibly responsible for the curvature
• with previous surgical or orthotic treatment or
• physical or mental disability that prevent patients from complying with the bracing protocol

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Study Officials

• Adam Yiu Chung Lau, FRCSEd (Orth)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 1, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)