Adolescent Idiopathic Scoliosis (AIS)NCT07045337
Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol
A study testing Hybrid Bracing and Conventional fulltime Underarm Bracing in people with Adolescent Idiopathic Scoliosis (AIS), run by Chinese University of Hong Kong at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Hybrid Bracing and Conventional fulltime Underarm Bracing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol: A Randomized-Controlled Trial
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).
Read the detailed description
Scoliosis is a complex three-dimensional spinal deformity and AIS is the commonest with a high prevalence of 2-4%. If left untreated, AIS can progress resulting in significant health problems including back degeneration and negative body images.
Bracing, such as Underarm Brace(UAB) used in our center, is indicated for skeletally immature patients with Cobb angle>20°. Another bracing system is a nighttime Lateral Bending Brace(LBB) designed in a bending position opposite to the convexity of the curve thus resulting in its overcorrection. If AIS becomes severe despite bracing, ultra-major surgery is indicated aiming at bony fusion of the deformed segment with instrumentation. It is therefore important to maximize treatment effectiveness with bracing to control curve progression and to avoid the need for surgery. In-brace Correction(IBC) is the percentage reduction in Cobb angle with bracing.
Studies have reported IBC is an important determinant of brace effectiveness. For enhancement of IBC, we put forward the Hybrid Bracing Protocol(HyBP) combining the use of daytime UAB and nighttime LBB. To be best of our knowledge, HyBP has never been reported in the literature. Our pilot study on 8 patients treated with HyBP and 8 Cobb-matched historical controls treated with fulltime UAB showed very promising results with IBC of 42.1±22.0% and 22.1±14.9% in the HyBP and control group respectively. We therefore propose a formal prospective rater-blinded randomized controlled trial on 120 skeletally immature AIS female subjects with single thoracolumbar or lumbar curve newly prescribed with bracing. They are randomly allocated to the HyBP Group or the Conventional Brace Group (CB Group). The primary objective is to determine if the HyBP Group has better treatment effect in terms of In-brace Correction (IBC) when compared with the CB group at 3-month and 18-month after bracing. This is a 3-year study proposal representing the first phase of a project, to be followed by the second phase of the project when all subjects of the entire cohort will be assessed on curve outcome at time of completion of bracing and at 2 years post-bracing. This study will carry significant clinical impacts in that, if proven useful, the HyBP can be used for enhancement of treatment outcomes with bracing, thus preventing the scoliotic spine from deterioration and to avoid the need for surgery.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Hybrid Bracing, Conventional fulltime Underarm Bracing
- Keywords
- Adolescent Idiopathic Scoliosis, Bracing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid BracingOther
Hybrid Bracing includes daytime Underarm Brace(UAB) and nighttime Lateral Bending Brace(LBB)
Conventional fulltime Underarm BracingOther
Conventional group includes fulltime Underarm Brace (UAB) only.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Bracing | Experimental | Hybrid Bracing Protocol (HyBP) combining the use of daytime Underarm Brace (UAB) and a nighttime Lateral Bending Brace Receives: Other: Hybrid Bracing |
| Conventional fulltime underarm bracing (UAB) | Active comparator | Conventional group uses fulltime underarm bracing (UAB) Receives: Other: Conventional fulltime Underarm Bracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity
Secondary outcomes (2)
Curve progression
To determine if the HyBP has better treatment outcomes in terms of control of curve progression when compared with the conventional fulltime UAB
Measured: From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity
Quality of life questionnaires
To determine if the HyBP has better outcomes when compared with the conventional fulltime UAB in terms of quality of life as assessed by SRS-22r, Spinal Appearance Questionnaire and the Brace Questionnaire
Measured: From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jan 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsz-ping Lam, Chinese University of Hong Kong
- Investigators
- Adam Yiu Chung Lau, FRCSEd (Orth), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045337
- Sponsor's protocol ID
- GRF 14119721
- Other IDs
- 14119721
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy
Publications
Lau AYC, Kee HM, Yang KG, Kwan ECK, Hung ALH, Lee WYW, Wong MS, Cheng JCY, Lam TP. Full-time bracing versus hybrid bracing in adolescent idiopathic scoliosis: study protocol for a randomised controlled trial. Trials. 2026 May 19;27(1):483. doi: 10.1186/s13063-026-09787-0.
PubMed 42152027
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT07045337
- Acronym / sponsor ID
- GRF 14119721
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Adolescent Idiopathic Scoliosis, Bracing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Scoliosis is a complex three-dimensional spinal deformity and AIS is the commonest with a high prevalence of 2-4%. If left untreated, AIS can progress resulting in significant health problems including back degeneration and negative body images.
Bracing, such as Underarm Brace(UAB) used in our center, is indicated for skeletally immature patients with Cobb angle>20°. Another bracing system is a nighttime Lateral Bending Brace(LBB) designed in a bending position opposite to the convexity of the curve thus resulting in its overcorrection. If AIS becomes severe despite bracing, ultra-major surgery is indicated aiming at bony fusion of the deformed segment with instrumentation. It is therefore important to maximize treatment effectiveness with bracing to control curve progression and to avoid the need for surgery. In-brace Correction(IBC) is the percentage reduction in Cobb angle with bracing.
Studies have reported IBC is an important determinant of brace effectiveness. For enhancement of IBC, we put forward the Hybrid Bracing Protocol(HyBP) combining the use of daytime UAB and nighttime LBB. To be best of our knowledge, HyBP has never been reported in the literature. Our pilot study on 8 patients treated with HyBP and 8 Cobb-matched historical controls treated with fulltime UAB showed very promising results with IBC of 42.1±22.0% and 22.1±14.9% in the HyBP and control group respectively. We therefore propose a formal prospective rater-blinded randomized controlled trial on 120 skeletally immature AIS female subjects with single thoracolumbar or lumbar curve newly prescribed with bracing. They are randomly allocated to the HyBP Group or the Conventional Brace Group (CB Group). The primary objective is to determine if the HyBP Group has better treatment effect in terms of In-brace Correction (IBC) when compared with the CB group at 3-month and 18-month after bracing. This is a 3-year study proposal representing the first phase of a project, to be followed by the second phase of the project when all subjects of the entire cohort will be assessed on curve outcome at time of completion of bracing and at 2 years post-bracing. This study will carry significant clinical impacts in that, if proven useful, the HyBP can be used for enhancement of treatment outcomes with bracing, thus preventing the scoliotic spine from deterioration and to avoid the need for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Bracing | Experimental | Other: Hybrid BracingHybrid Bracing Protocol (HyBP) combining the use of daytime Underarm Brace (UAB) and a nighttime Lateral Bending Brace |
| Conventional fulltime underarm bracing (UAB) | Active comparator | Other: Conventional fulltime Underarm BracingConventional group uses fulltime underarm bracing (UAB) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid BracingHybrid Bracing includes daytime Underarm Brace(UAB) and nighttime Lateral Bending Brace(LBB) | Other | Hybrid Bracing |
| Conventional fulltime Underarm BracingConventional group includes fulltime Underarm Brace (UAB) only. | Other | Conventional fulltime underarm bracing (UAB) |
Primary outcome
In-brace Correction (IBC)
Time frame: 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.
2 secondary outcomes
Curve progression
Time frame: From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity
Quality of life questionnaires
Time frame: From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 42152027Lau AYC, Kee HM, Yang KG, Kwan ECK, Hung ALH, Lee WYW, Wong MS, Cheng JCY, Lam TP. Full-time bracing versus hybrid bracing in adolescent idiopathic scoliosis: study protocol for a randomised controlled trial. Trials. 2026 May 19;27(1):483. doi: 10.1186/s13063-026-09787-0.
- Individual participant dataSharing planned: No. Patient privacy
Related trials for Adolescent Idiopathic Scoliosis (AIS)
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Yiu Chung Lau, FRCSEd (Orth) principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Bracing and Conventional fulltime Underarm Bracing in people with Adolescent Idiopathic Scoliosis (AIS), run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-brace Correction (IBC) (time frame: From date of randomization, assessed up to 2 years after bracing stopped at skeletal maturity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.