Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device Devised to Maintain Lumbar Lordosis : 5 Year Follow up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 3
- 主要终点
- Incidence of scoliosis
研究概览
简要总结
This study will be conducted without blind method. The portable seat device devised to maintain lumbar lordosis will be made within 1 year after the loss of ambulation in the participants with Duchenne muscular dystrophy with prospective design.
In the control group, the presence of scoliosis will be calculated 5 years after the loss of ambulation in participants with Duchenne muscular dystrophy through analysis of retrospective medical records who had not been applied the portable seat device.
详细描述
In the retrospective data of Seoul National University Children's Hospital, the incidence of 5-year scoliosis in the control group in the past using steroids alone was 70% in patients with confirmed Duchenne muscular dystrophy. When applying the portable seat device (experimental group), the incidence of scoliosis is expected to decrease to 50% (ie, 35% because of 50% of 70%) compared with using steroid alone.
In this study, investigators will enroll 70 control subjects who did not use the portable seat device through retrospective data. The number of subjects required to show the difference between the significance level of 5% and the power of 80% was 19, and 28 participants with DMD are required considering 30% dropout rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with the diagnosis of Duchenne muscular dystrophy diagnosed by genetic study were included.
- •Within 1 year after loss of ambulation (Vignos scale 7 points or more)
- •Condition without scoliosis
- •Conditions that do not have physical (eg, cerebral palsy) and mental (eg, moderate or higher intellectual disability) comorbid conditions that will affect the use of postural seat device.
排除标准
- •Patients who do not agree to participate in this study
- •Patients not taking steroids
- •Patient with scoliosis
研究组 & 干预措施
Experimental group
When loss of ambulation was observed in patients with Duchenne muscular dystrophy, portable seat device devised to maintain lumbar lordosis were applied within 1 year, and then compliance with the the device were evaluated at 6-month intervals for 5 years.
干预措施: Portable seat device devised to maintain lumbar lordosis (Device)
Control group
Analysis of retrospective medical records who had not been applied portable seat device devised to maintain lumbar lordosis
结局指标
主要结局
Incidence of scoliosis
时间窗: 5 years after loss of ambulation
Frequency of scoliosis more than 10 degrees on spine x-ray on supine position
次要结局
- Incidence of scoliosis("Day 0", "Month 6" "Month 12" "Month 18" "Month 24" "Month 30" "Month 36" "Month 42" "Month 48" "Month 54" "Month 60")
研究者
Hyung-ik Shin
Associate professor
Seoul National University Hospital