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 range

10 Years – 18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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