NCT03611244

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Male
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Scoliosis Neuromuscular
• Duchenne Muscular Dystrophy
• Lordosis Lumbar

Interventions

Type	Name	Description
DEVICE	Portable seat device devised to maintain lumbar lordosis	The posterior lumbar spine pads are used to maintain lumbar lordosis and fix it with the shoulder strap so that the hip does not slip forward (so that it does not become a sacral sitting posture). The seat is equipped with a 5 cm air filled villus cushion to relieve pressure on the ischial tuberosity when sitting for a long time. The portable seat device can be moved so that the DMD can sit on the device even when sitting in a wheelchair or a chair for home, school, or outdoors, so that the lumbar lordosis can be constantly maintained.

Timeline

• Start date: 2018-08-07
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2018-08-02
• Last updated: 2018-09-18

Locations

2 sites across 1 country: South Korea