Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03611244
Status:
RECRUITING
Last Update Posted:
2018-09-18
First Post:
2018-07-25
Brief Title:
Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Childrens 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None