Adolescent Idiopathic ScoliosisNCT07246122
MRI-Guided Dynamic Support System for Scoliosis Correction
A study testing MRI-guided Dynamic Support System in people with Adolescent Idiopathic Scoliosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- MRI-guided Dynamic Support System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Jul 2023to 31 Dec 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 10-16 years
- Diagnosis: Adolescent idiopathic scoliosis (Cobb angle 10-25°)
- No prior spinal surgery or other orthopedic conditions
- Able to provide informed consent
- Risser sign 0-5
Who cannot join
- Age <10 or >16 years
- Cobb angle <10° or >25°
- History of spinal surgery or other spine disorders
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Tsim Sha Tsui, Kowloon
Joanne Yip, PhD, 27664848
About this study
Official title: MRI-Guided Dynamic Support System for Scoliosis Correction (MRI-DSS)
This prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). The system uses MRI-compatible air padding supports and programmable pneumatic control to apply and adjust corrective forces in real time. AIS patients underwent MRI-guided bracing, with Cobb angles and biomechanical parameters measured at each pressure level.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- MRI-guided Dynamic Support System
- Keywords
- MRI, Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided Dynamic Support SystemDevice
MRI-compatible pneumatic support system with customized padding inserted into the brace, used for image-guided adjustment of corrective pressure during MRI scanning
| Study group | Role | What they receive |
|---|---|---|
| AIS bracing group | Experimental | Moderate AIS patients wearing customized MRI compatible soft brace, supine position lie in the MRI device Receives: Device: MRI-guided Dynamic Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobb angle
degrees measured by MRI
Measured: baseline
Time to achieve target correction
measured in minutes
Measured: immediately after the intervention
Secondary outcomes (1)
Contact area and force distribution
measured by 3D MRI reconstruction
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start27 Jul 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Tong, PhD, Principal investigator, Chinese University of Hong KongJoanne Yip, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246122
- Sponsor's protocol ID
- HSEARS20230614001
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Guided Dynamic Support System for Scoliosis Correction (MRI-DSS)
- ClinicalTrials.gov ID
- NCT07246122
- Acronym / sponsor ID
- HSEARS20230614001
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- MRI, Scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Nov 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 prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). The system uses MRI-compatible air padding supports and programmable pneumatic control to apply and adjust corrective forces in real time. AIS patients underwent MRI-guided bracing, with Cobb angles and biomechanical parameters measured at each pressure level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIS bracing group | Experimental | Device: MRI-guided Dynamic Support SystemModerate AIS patients wearing customized MRI compatible soft brace, supine position lie in the MRI device |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 10-16 years
- Diagnosis: Adolescent idiopathic scoliosis (Cobb angle 10-25°)
- No prior spinal surgery or other orthopedic conditions
- Able to provide informed consent
- Risser sign 0-5
Key exclusion criteria (4 listed)
- Age <10 or >16 years
- Cobb angle <10° or >25°
- History of spinal surgery or other spine disorders
- Contraindications to MRI
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 |
|---|---|---|
| MRI-guided Dynamic Support SystemMRI-compatible pneumatic support system with customized padding inserted into the brace, used for image-guided adjustment of corrective pressure during MRI scanning | Device | AIS bracing group |
Primary outcome
Change in Cobb angle
Time frame: baseline
degrees measured by MRI
Time to achieve target correction
Time frame: immediately after the intervention
measured in minutes
1 secondary outcome
Contact area and force distribution
Time frame: immediately after the intervention
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 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Raymond Tong, PhD principal investigator
Chinese University of Hong Kong
Joanne Yip, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-guided Dynamic Support System in people with Adolescent Idiopathic Scoliosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Nov 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 Hong Kong. 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?
Contact Raymond Tong, PhD (39438454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cobb angle (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.