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

Not Applicable

Recruiting

• Conditions: Lordosis Lumbar; Scoliosis Neuromuscular; Duchenne Muscular Dystrophy
• Interventions: Device: Portable seat device devised to maintain lumbar lordosis

• Registration Number: NCT03611244
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2018-08-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-15
• Last Update Posted: 2018-09-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Portable seat device devised to maintain lumbar lordosis	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.

Primary Outcome Measures

Name	Time	Method
Incidence of scoliosis	5 years after loss of ambulation	Frequency of scoliosis more than 10 degrees on spine x-ray on supine position

Secondary Outcome Measures

Name	Time	Method
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"	Comparison of cobb's angle on spine x-ray on supine position

Trial Locations

Locations (2)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of