Duchenne Muscular Dystrophy Clinical Trial
Official title:
Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device Devised to Maintain Lumbar Lordosis : 5 Year Follow up Study
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.
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.
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