Back to resultsDevelopment of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)
Primary Purpose
Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
asymmetrical stabilization exercise
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Scoliosis focused on measuring surface EMG, cobb angle, exercise, Spinal Curvatures
Eligibility Criteria
Inclusion Criteria:
- X-ray shows a cobb angle of 10 degrees or higher.
- Patients 8 and older.
Exclusion Criteria:
- Patients with spinal surgery
- Patients with scoliosis caused by cerebral palsy, muscle paralysis, polio, congenital spinal cord abnormalities, etc.
- Cobb angle less than 10 degrees and more than 40 degrees
- Patients with acute back pain
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
asymmetrical stabilization exercise group
Arm Description
'asymmetrical stabilization exercise' patient learn asymmetrical stabilization exercise according to the asymmetrical paraspinal muscles weakness and curve type
Outcomes
Primary Outcome Measures
Cobb angle
the angle of curvature be measured by drawing lines parallel to the upper border of the upper vertebral body and the lower border of the lowest vertebra of the structural curve on plain radiography
Secondary Outcome Measures
Scoliosis Research Society-22(SRS-22)
questionnaire for evaluating quality of life in patients with idiopathic scoliosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03675984
Brief Title
Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)
Official Title
Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 22, 2016 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ju Seok Ryu
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
There has been much effort in recent years to better understand the causes of idiopathic scoliosis (IS). Some studies suggested muscle imbalance as a cause of scoliosis based on asymmetric muscular activation. Surface electromyography can evaluate asymmetrical muscular weakness. Therefore, the peak amplitude values can be used to compare the side to side differences in paraspinal muscles. From these findings the investigators improve the exercise method of IS according to muscle weakness and curve pattern.
Detailed Description
Design: Prospective study Setting: hospital rehabilitation department the investigators will check the muscular activation at bilateral paraspinal muscles with surface electromyography and curve type with simple radiography.
Intervention: After that the investigators educate asymmetrical stabilization exercise according to muscle weakness and curve pattern.
Main outcome measures: Cobb angle
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
Keywords
surface EMG, cobb angle, exercise, Spinal Curvatures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Annual evaluation after educating asymmetrical stabilization exercise. Cohort study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
asymmetrical stabilization exercise group
Arm Type
Experimental
Arm Description
'asymmetrical stabilization exercise' patient learn asymmetrical stabilization exercise according to the asymmetrical paraspinal muscles weakness and curve type
Intervention Type
Behavioral
Intervention Name(s)
asymmetrical stabilization exercise
Intervention Description
Exercise is combined to form an appropriate combination of motion (Side-lying, Bird-dog, Prone arm lift, Prone leg lift) according to the curve pattern and muscle weakness of each patient's.
Primary Outcome Measure Information:
Title
Cobb angle
Description
the angle of curvature be measured by drawing lines parallel to the upper border of the upper vertebral body and the lower border of the lowest vertebra of the structural curve on plain radiography
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Scoliosis Research Society-22(SRS-22)
Description
questionnaire for evaluating quality of life in patients with idiopathic scoliosis
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
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
X-ray shows a cobb angle of 10 degrees or higher.
Patients 8 and older.
Exclusion Criteria:
Patients with spinal surgery
Patients with scoliosis caused by cerebral palsy, muscle paralysis, polio, congenital spinal cord abnormalities, etc.
Cobb angle less than 10 degrees and more than 40 degrees
Patients with acute back pain
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Kyungji-do
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)
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