Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device

  • STATUS
    Recruiting
  • End date
    Dec 22, 2024
  • participants needed
    98
  • sponsor
    Seoul National University Hospital
Updated on 22 January 2021
muscular dystrophy

Summary

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.

Description

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.

Details
Condition Muscular Dystrophy, Muscular Dystrophy, DUCHENNE MUSCULAR DYSTROPHY, Neuromuscular Scoliosis, Scoliosis Neuromuscular, Lordosis Lumbar
Treatment Portable seat device devised to maintain lumbar lordosis
Clinical Study IdentifierNCT03611244
SponsorSeoul National University Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients who do not agree to participate in this study
Patients not taking steroids
Patient with scoliosis
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