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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03611244
• Other study ID #: 1806-171-955 SNUH
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: December 2024

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: You Gyoung Yi, M.D., MSc
• Phone: 82-10-9683-7582
• Email: lyk861124[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 15 Years

Eligibility

Inclusion Criteria:

• Patients with the diagnosis of Duchenne muscular dystrophy diagnosed by genetic study were included.

1. Within 1 year after loss of ambulation (Vignos scale 7 points or more)

2. Condition without scoliosis

3. 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:

1. Patients who do not agree to participate in this study

2. Patients not taking steroids

3. Patient with scoliosis

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Lordosis
• Lordosis Lumbar
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Scoliosis
• Scoliosis Neuromuscular

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of scoliosis	Frequency of scoliosis more than 10 degrees on spine x-ray on supine position	5 years after loss of ambulation
Secondary	Incidence of scoliosis	Comparison of cobb's angle on spine x-ray on supine position	"Day 0", "Month 6" "Month 12" "Month 18" "Month 24" "Month 30" "Month 36" "Month 42" "Month 48" "Month 54" "Month 60"