Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03611244|
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : September 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Scoliosis Neuromuscular Duchenne Muscular Dystrophy Lordosis Lumbar||Device: Portable seat device devised to maintain lumbar lordosis||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Experimental group
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
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.
No Intervention: Control group
Analysis of retrospective medical records who had not been applied portable seat device devised to maintain lumbar lordosis
- Incidence of scoliosis [ Time Frame: 5 years after loss of ambulation ]Frequency of scoliosis more than 10 degrees on spine x-ray on supine position
- Incidence of scoliosis [ Time Frame: "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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611244
|Contact: You Gyoung Yi, M.D., MScfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University||Recruiting|
|Seoul, Korea, Republic of, 03080|
|Contact: Hyung-Ik Shin, PhD +82-02-2072-3218 email@example.com|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: You Gyoung Yi, M.D. 82-10-9683-7582 firstname.lastname@example.org|
|Principal Investigator:||You Gyoung Yi, M.D., MSc||Seoul National University Hospital|