跳至主要内容
临床试验/NCT04012112
NCT04012112已完成不适用

The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis : A Longitudinal Study

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
change of the scoliosis

研究概览

简要总结

In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.

研究设计

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

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 20-45' degrees of cobb's angle in the neuromuscular disease

排除标准

  • patient's who had spinal surgery
  • less than 20 degree or more than 45 degree of cobb's angle
  • acute lumbar pain

结局指标

主要结局

change of the scoliosis

时间窗: 6months

Cobb's angle in the whole spine anteroposterior view of X-ray before, immediately after, and 6-month after wearing FLEXpine brace

次要结局

  • change of pain(6months)
  • change of pulmonary function(6 months)
  • change of quality of life(6 months)

研究者

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

Ju Seok Ryu

associate professor

Seoul National University Hospital

研究点 (2)

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