Active — Not RecruitingNot Applicable

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

China120 participantsStarted 2022-01-01

Plain-language 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).

Who can participate

Age range10 Years – 18 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

In-brace Correction (IBC)

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

Trial details

NCT IDNCT07045337

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Adolescent Idiopathic Scoliosis (AIS) trials