- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03497520
The Effect of Asymmetric Spinal Stabilization Exercise on Scoliosis
April 18, 2024 updated by: Ju Seok Ryu, Seoul National University Hospital
The purpose of this study is to evaluate the effect of asymmetric spinal stabilization exercise on scoliosis
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
- Design: Prospective study
- Setting: hospital rehabilitation department
- Intervention: Participants are educated asymmetric spinal stabilization exercise along scoliosis curve patterns, including the location of apex and the direction of convexity. After performing asymmetric spinal stabilization exercise, participants are compared the main outcome measures.
- Main outcome measures: Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jusuk Ryu, M.D. PhD
- Phone Number: +82-31-787-7739
- Email: jseok337@snu.ac.kr
Study Contact Backup
- Name: Yulhyun Park, M.D.
- Email: yulhyunp@gmail.com
Study Locations
-
-
Gyeonggi-do
-
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- who have idiopathic scoliosis, showing at Cobb's angle over 10 degrees 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 10 degrees, over 40 degrees
- Patients complaining of acute low back pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: scoliosis patients
scoliosis patients who have cobb angle over 10 degree perform asymmetric spinal stabilization exercise
|
The patients were educated to strengthening weakness side of spinal muscle, as asymmetric spinal stabilization exercise(ASSE)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cobb angle
Time Frame: through study completion, an average of 6 months
|
measure lateral curve of vertebra on spine x-ray AP view
|
through study completion, an average of 6 months
|
Apical vertebral rotation
Time Frame: through study completion, an average of 1 year
|
angle of trunk rotation in Adam's test
|
through study completion, an average of 1 year
|
surface electromyography
Time Frame: through study completion, an average of 6 months
|
surface muscle contraction of bilateral spinal muscle on T7, T12, L3
|
through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scoliosis Research Society-22(SRS-22) quastionnaire
Time Frame: through study completion, an average of 1 year
|
five different factors (pain, self-image/appearance, function/activity, mental health, and satisfaction with management, 5 = best; 1 = worst)the minimum and maximum score range is from 5 to 25
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jusuk Ryu, M.D. PhD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2018
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 29, 2018
First Submitted That Met QC Criteria
April 12, 2018
First Posted (Actual)
April 13, 2018
Study Record Updates
Last Update Posted (Estimated)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1701/377-305
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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