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

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ClinicalTrials.gov Identifier: NCT03611244
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hyung-ik Shin, 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.


Condition or disease Intervention/treatment Phase
Scoliosis Neuromuscular Duchenne Muscular Dystrophy Lordosis Lumbar Device: Portable seat device devised to maintain lumbar lordosis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: You Gyoung Yi, M.D., MSc 82-10-9683-7582 lyk861124@gmail.com

Locations
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Korea, Republic of
Seoul National University Recruiting
Seoul, Korea, Republic of, 03080
Contact: Hyung-Ik Shin, PhD    +82-02-2072-3218    hyungik1@snu.ac.kr   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: You Gyoung Yi, M.D.    82-10-9683-7582    lyk861124@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: You Gyoung Yi, M.D., MSc Seoul National University Hospital

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Responsible Party: Hyung-ik Shin, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03611244     History of Changes
Other Study ID Numbers: 1806-171-955 SNUH
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Dystrophy, Duchenne
Muscular Dystrophies
Scoliosis
Lordosis
Swayback
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Spinal Curvatures
Spinal Diseases
Bone Diseases
Genetic Diseases, X-Linked
Deficiency Diseases
Malnutrition
Nutrition Disorders
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents