Adolescent Idiopathic Scoliosis (AIS)NCT07040150
Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Nippon Sigmax co., ltd. at 1 site in Japan.
Trial summary
Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Spinal bracing
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 24 Dec 2019to Mar 2027
- Phase
- Observational
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Conducted at seven medical institutions in Japan.
Who may be able to join
- diagnosed AIS
- Risser sign ≤ 2
- Cobb angle between 25° and 40°
- age ≥ 10 years
- single-curve pattern (thoracic or thoracolumbar/ lumbar)
- premenarchial or less than one year post-menarche.
Who cannot join
- Patients who do not meet the SRS criteria for orthosis suitability
- Patients with a history of spinal surgery
Trial locations and contacts
1 site in 1 country.
Japan1 site
Aizu Medical Center at Fukushima Medical University
Aizu-Wakamatsu, Fukushima, 969-3492
About this study
Official title: Development and Short-Term Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis: Results From a Multicenter Prospective Observational Study of the First 60 Patients
Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate.
Materials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤ 2, (3) Cobb angle between 25° and 40°, (4) age ≥ 10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Spinal bracing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal bracingDevice
The semi-rigid spinal brace was developed to enhance patient compliance while maintaining effective curve correction. Patients were instructed to wear the brace for 18-20 h daily.
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearing time
Measured: 180 days from registration
Secondary outcomes (3)
Initial correction rate
Measured: Immediately after registration
Correction rate after 180 days or more
Measured: 180 days or more from registration
Treatment success rate
Measured: 2 years or more from registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start24 Dec 2019
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nippon Sigmax co., ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040150
- Sponsor's protocol ID
- AMEC brace study
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not be sharing individual participant data (IPD) due to privacy concerns.
Publications
Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2068-75; discussion 2076-7. doi: 10.1097/01.brs.0000178819.90239.d0.
PubMed 16166897Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
PubMed 24047455Hirata K, Shirado O, Suzuki N, Iida T, Inoue M, Inage K, Katayanagi J, Matsumoto K, Nikaido T, Abe M, Endo T. Development and short-term evaluation of a novel semi-rigid brace for adolescent idiopathic scoliosis: Results from a multicenter prospective observational study of the first 60 patients. Prosthet Orthot Int. 2026 Feb 17. doi: 10.1097/PXR.0000000000000519. Online ahead of print.
PubMed 41700840
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Short-Term Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis: Results From a Multicenter Prospective Observational Study of the First 60 Patients
- ClinicalTrials.gov ID
- NCT07040150
- Acronym / sponsor ID
- AMEC brace study
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nippon Sigmax co., ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Jun 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.
Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate.
Materials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤ 2, (3) Cobb angle between 25° and 40°, (4) age ≥ 10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Conducted at seven medical institutions in Japan.
Key inclusion criteria (6 listed)
- diagnosed AIS
- Risser sign ≤ 2
- Cobb angle between 25° and 40°
- age ≥ 10 years
- single-curve pattern (thoracic or thoracolumbar/ lumbar)
Key exclusion criteria (2 listed)
- Patients who do not meet the SRS criteria for orthosis suitability
- Patients with a history of spinal surgery
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 |
|---|---|---|
| Spinal bracingThe semi-rigid spinal brace was developed to enhance patient compliance while maintaining effective curve correction. Patients were instructed to wear the brace for 18-20 h daily. | Device | – |
Primary outcome
Wearing time
Time frame: 180 days from registration
3 secondary outcomes
Initial correction rate
Time frame: Immediately after registration
Correction rate after 180 days or more
Time frame: 180 days or more from registration
Treatment success rate
Time frame: 2 years or more from registration
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 1 Jul 2025.
- Background: PubMed 16166897Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2068-75; discussion 2076-7. doi: 10.1097/01.brs.0000178819.90239.d0.
- Background: PubMed 24047455Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
- Derived from this study: PubMed 41700840Hirata K, Shirado O, Suzuki N, Iida T, Inoue M, Inage K, Katayanagi J, Matsumoto K, Nikaido T, Abe M, Endo T. Development and short-term evaluation of a novel semi-rigid brace for adolescent idiopathic scoliosis: Results from a multicenter prospective observational study of the first 60 patients. Prosthet Orthot Int. 2026 Feb 17. doi: 10.1097/PXR.0000000000000519. Online ahead of print.
- Individual participant dataSharing planned: No. The investigators will not be sharing individual participant data (IPD) due to privacy concerns.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Nippon Sigmax co., ltd. at 1 site in Japan.
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 2 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 1 Jul 2025. 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 Japan. 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?
Wearing time (time frame: 180 days from registration). 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 NCT07040150, which also lists 3 linked publications.
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 1 Jul 2025.