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

NCT03611244 | Unknown

• 1 other identifier: 1806-171-955 SNUH
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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.

Conditions

Scoliosis Neuromuscular; Duchenne Muscular Dystrophy; Lordosis Lumbar

Outcome Measures

Primary Outcomes (1)

• Incidence of scoliosis

  Frequency of scoliosis more than 10 degrees on spine x-ray on supine position

  5 years after loss of ambulation

Secondary Outcomes (1)

• 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"

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Device: Portable seat device devised to maintain lumbar lordosis

Control group

NO INTERVENTION

Analysis of retrospective medical records who had not been applied portable seat device devised to maintain lumbar lordosis

Interventions

Portable seat device devised to maintain lumbar lordosis DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University

Seoul, 03080, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• You Gyoung Yi, M.D., MSc

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

You Gyoung Yi, M.D., MSc

CONTACT

82-10-9683-7582; lyk861124@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 2, 2018
• Study Start: August 7, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)