Back to resultsThe Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
flexible thoracolumbar brace
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Palsy focused on measuring Cerebral palsy, Brace, Scoliosis
Eligibility Criteria
Inclusion Criteria:
- GMFCS level III, IV, V of the Cerebral palsy
- 20-45 degree of Cobb's angle
Exclusion Criteria:
- less than 20 degree or more than 45 degree of Cobb's angle
- Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
- Acute lumbar pain
- Fixed scoliosis
Sites / Locations
- Seoul national university bundang hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prospective, single-arm trial
Arm Description
Outcomes
Primary Outcome Measures
Change of scoliosis
Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace
Secondary Outcome Measures
Pain of the back (thorax)
Patients check the scale through the visual analog scale
change of quality of life (aspect of the parents)
Parent of the patients assessed "caregiver experience with neuromuscular disease" before and 6-month after wearing FLEXpine brace
Full Information
NCT ID
NCT04012125
First Posted
June 5, 2019
Last Updated
July 20, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04012125
Brief Title
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
Official Title
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (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 Scoliosis in Cerebral Palsy, Prospective, Randomized, Open-label Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Brace, Scoliosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective, single-arm trial
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
flexible thoracolumbar brace
Intervention Description
Subjects would wear the flexible thoracolumbar brace over 18 hours a day
Primary Outcome Measure Information:
Title
Change of scoliosis
Description
Cobb's angle in the whole spine anteroposterior view of X-ray, before and immediately after, and 6months after wearing FLEXpine brace
Time Frame
6months
Secondary Outcome Measure Information:
Title
Pain of the back (thorax)
Description
Patients check the scale through the visual analog scale
Time Frame
6 months
Title
change of quality of life (aspect of the parents)
Description
Parent of the patients assessed "caregiver experience with neuromuscular disease" before and 6-month after wearing FLEXpine brace
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
GMFCS level III, IV, V of the Cerebral palsy
20-45 degree of Cobb's angle
Exclusion Criteria:
less than 20 degree or more than 45 degree of Cobb's angle
Neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis
Acute lumbar pain
Fixed scoliosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUSEOK RYU, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul national university bundang hospital
City
Seongnam-si
State/Province
Bundang-gu
ZIP/Postal Code
13354
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
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