Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device
Primary Purpose
Scoliosis Neuromuscular, Duchenne Muscular Dystrophy, Lordosis Lumbar
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Portable seat device devised to maintain lumbar lordosis
Sponsored by
About this trial
This is an interventional prevention trial for Scoliosis Neuromuscular
Eligibility Criteria
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
Sites / Locations
- Seoul National UniversityRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
Analysis of retrospective medical records who had not been applied portable seat device devised to maintain lumbar lordosis
Outcomes
Primary Outcome Measures
Incidence of scoliosis
Frequency of scoliosis more than 10 degrees on spine x-ray on supine position
Secondary Outcome Measures
Incidence of scoliosis
Comparison of cobb's angle on spine x-ray on supine position
Full Information
NCT ID
NCT03611244
First Posted
July 25, 2018
Last Updated
September 15, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03611244
Brief Title
Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Neuromuscular, Duchenne Muscular Dystrophy, Lordosis Lumbar
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Analysis of retrospective medical records who had not been applied portable seat device devised to maintain lumbar lordosis
Intervention Type
Device
Intervention Name(s)
Portable seat device devised to maintain lumbar lordosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of scoliosis
Description
Frequency of scoliosis more than 10 degrees on spine x-ray on supine position
Time Frame
5 years after loss of ambulation
Secondary Outcome Measure Information:
Title
Incidence of scoliosis
Description
Comparison of cobb's angle on spine x-ray on supine position
Time Frame
"Day 0", "Month 6" "Month 12" "Month 18" "Month 24" "Month 30" "Month 36" "Month 42" "Month 48" "Month 54" "Month 60"
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
You Gyoung Yi, M.D., MSc
Phone
82-10-9683-7582
Email
lyk861124@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Gyoung Yi, M.D., MSc
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-Ik Shin, PhD
Phone
+82-02-2072-3218
Email
hyungik1@snu.ac.kr
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You Gyoung Yi, M.D.
Phone
82-10-9683-7582
Email
lyk861124@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device
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