The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography
Primary Purpose
Idiopathic Scoliosis
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gait with leg length discrepancy
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Scoliosis
Eligibility Criteria
Inclusion Criteria:
- Healthy children (5 to 12 years old)
Exclusion Criteria:
- Children with leg length discrepancy over 0.5cm
- Children complaining of acute low back pain
- Children with spinal scoliosis
- Children with cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
- Children who underwent spinal surgery
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy children (5 to 12 years old)
Arm Description
Outcomes
Primary Outcome Measures
surface electromyography
surface muscle contraction of bilateral back muscles
bilateral spinal muscles on T6, T12, L3
bilateral quadratus lumborum muscles
bilateral iliopsoas muscles
Secondary Outcome Measures
Full Information
NCT ID
NCT05333796
First Posted
April 12, 2022
Last Updated
April 16, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05333796
Brief Title
The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography
Official Title
The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
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
The purpose of this study is to evaluate the effect of back muscle activations on idiopathic scoliosis
Detailed Description
Design: Prospective study
Setting: hospital rehabilitation department
Intervention: Participants were asked to walk with a surface electromyography(EMG) attached to their back muscles. After repeating the same process with different leg lengths discrepancy (0cm, 0.5cm, 1cm), participants are compared the main outcome measures.
Main outcome measures: surface electromyography(EMG)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy children (5 to 12 years old)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
gait with leg length discrepancy
Intervention Description
After attaching the surface electromyography(EMG) to bilateral back muscles, participants walk at a comfortable speed. The investigators will evaluate the effects of leg length discrepancy on the back muscle activation during gait.
Primary Outcome Measure Information:
Title
surface electromyography
Description
surface muscle contraction of bilateral back muscles
bilateral spinal muscles on T6, T12, L3
bilateral quadratus lumborum muscles
bilateral iliopsoas muscles
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy children (5 to 12 years old)
Exclusion Criteria:
Children with leg length discrepancy over 0.5cm
Children complaining of acute low back pain
Children with spinal scoliosis
Children with cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
Children who underwent spinal surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jusuk Ryu, M.D. PhD
Phone
+82-31-787-7739
Email
jseok337@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwoon Lim, M.D.
Email
jlovej71@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jusuk Ryu, M.D. PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jusuk Ryu, M.D, PhD
Phone
+82-31-787-7739
Email
jseok337@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jiwoon Lim, M.D
Phone
+82-31-787-7739
Email
jlovej71@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography
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