NCT07246122

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Jul 2023Dec 2027

Study Start

First participant enrolled

July 27, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

4.4 years

First QC Date

July 29, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

MRIScoliosis

Outcome Measures

Primary Outcomes (2)

  • Change in Cobb angle

    degrees measured by MRI

    baseline

  • Time to achieve target correction

    measured in minutes

    immediately after the intervention

Secondary Outcomes (1)

  • Contact area and force distribution

    immediately after the intervention

Study Arms (1)

AIS bracing group

EXPERIMENTAL

Moderate AIS patients wearing customized MRI compatible soft brace, supine position lie in the MRI device

Device: MRI-guided Dynamic Support System

Interventions

MRI-compatible pneumatic support system with customized padding inserted into the brace, used for image-guided adjustment of corrective pressure during MRI scanning

AIS bracing group

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Age \<10 or \>16 years
  • Cobb angle \<10° or \>25°
  • History of spinal surgery or other spine disorders
  • Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Tsim Sha Tsui, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Raymond Tong, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • Joanne Yip, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

Joanne Yip, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2025

First Posted

November 24, 2025

Study Start

July 27, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations