跳至主要内容
临床试验/NCT07246122
NCT07246122招募中不适用

MRI-Guided Dynamic Support System for Scoliosis Correction (MRI-DSS)

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Change in Cobb angle

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

AIS bracing group

Experimental

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

干预措施: MRI-guided Dynamic Support System (Device)

结局指标

主要结局

Change in Cobb angle

时间窗: baseline

degrees measured by MRI

Time to achieve target correction

时间窗: immediately after the intervention

measured in minutes

次要结局

  • Contact area and force distribution(immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raymond KY Tong

Professor

Chinese University of Hong Kong

研究点 (1)

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