Back to resultsThe Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis
Primary Purpose
Neuromuscular Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
thoracolumbar brace (Flexpine brace)
Sponsored by
About this trial
This is an interventional prevention trial for Neuromuscular Scoliosis focused on measuring brace, neuromuscular disease, scoliosis
Eligibility Criteria
Inclusion Criteria:
- 20-45' degrees of cobb's angle in the neuromuscular disease
Exclusion Criteria:
- patient's who had spinal surgery
- less than 20 degree or more than 45 degree of cobb's angle
- acute lumbar pain
Sites / Locations
- Seoul national university bundang hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single-arm trials
Arm Description
longitudial study of the thoracolumbar brace in the neuromuscular scoliosis for 6 months
Outcomes
Primary Outcome Measures
change of the scoliosis
Cobb's angle in the whole spine anteroposterior view of X-ray before, immediately after, and 6-month after wearing FLEXpine brace
Secondary Outcome Measures
change of pain
pain scale checked through the visual analog scale
change of pulmonary function
assessed by spirometer of forced vical capacity
change of quality of life
Parents assessed the quality of life through the muscular dystrophy spine qusetionnaire
Full Information
NCT ID
NCT04012112
First Posted
June 5, 2019
Last Updated
July 21, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04012112
Brief Title
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis
Official Title
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis : A Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 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
No
5. Study Description
Brief Summary
In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Scoliosis
Keywords
brace, neuromuscular disease, 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
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single-arm trials
Arm Type
Experimental
Arm Description
longitudial study of the thoracolumbar brace in the neuromuscular scoliosis for 6 months
Intervention Type
Device
Intervention Name(s)
thoracolumbar brace (Flexpine brace)
Intervention Description
Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month
Primary Outcome Measure Information:
Title
change of the scoliosis
Description
Cobb's angle in the whole spine anteroposterior view of X-ray before, immediately after, and 6-month after wearing FLEXpine brace
Time Frame
6months
Secondary Outcome Measure Information:
Title
change of pain
Description
pain scale checked through the visual analog scale
Time Frame
6months
Title
change of pulmonary function
Description
assessed by spirometer of forced vical capacity
Time Frame
6 months
Title
change of quality of life
Description
Parents assessed the quality of life through the muscular dystrophy spine qusetionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20-45' degrees of cobb's angle in the neuromuscular disease
Exclusion Criteria:
patient's who had spinal surgery
less than 20 degree or more than 45 degree of cobb's angle
acute lumbar pain
Facility Information:
Facility Name
Seoul national university bundang hospital
City
Seongnam-si
State/Province
Bundang
ZIP/Postal Code
13364
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis
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