Back to resultsThe Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
Primary Purpose
Scoliosis Idiopathic
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
scoliosis brace
Sponsored by
About this trial
This is an interventional health services research trial for Scoliosis Idiopathic
Eligibility Criteria
Inclusion Criteria:
- who have idiopathic scoliosis, showing at Cobb's angle over 20 degrees,less than 45 on X-ray
Exclusion Criteria:
- Patients who underwent spinal surgery
- Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
- Patients observed with Cobb's angle less than 20 degrees, over 45 degrees
- Patients complaining of acute low back pain
- Patients with cognitive impairment, severe mental illness, and inability to communicate
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
scoliosis patients
Arm Description
scoliosis patients who have cobb angle over 20 degree wear scoliosis brace for six months
Outcomes
Primary Outcome Measures
cobb angle
measure lateral curve of vertebra on spine x-ray AP view
Secondary Outcome Measures
Full Information
NCT ID
NCT03676712
First Posted
September 17, 2018
Last Updated
July 20, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03676712
Brief Title
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
Official Title
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment of subjects was not successful.
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)
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
Yes
5. Study Description
Brief Summary
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
scoliosis patients
Arm Type
Experimental
Arm Description
scoliosis patients who have cobb angle over 20 degree wear scoliosis brace for six months
Intervention Type
Device
Intervention Name(s)
scoliosis brace
Intervention Description
Wear at least 18 hours a day
Primary Outcome Measure Information:
Title
cobb angle
Description
measure lateral curve of vertebra on spine x-ray AP view
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
who have idiopathic scoliosis, showing at Cobb's angle over 20 degrees,less than 45 on X-ray
Exclusion Criteria:
Patients who underwent spinal surgery
Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
Patients observed with Cobb's angle less than 20 degrees, over 45 degrees
Patients complaining of acute low back pain
Patients with cognitive impairment, severe mental illness, and inability to communicate
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
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