Idiopathic ScoliosisNCT03675984
Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)
A study testing asymmetrical stabilization exercise in people with Idiopathic Scoliosis, run by Ju Seok Ryu at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 30 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- asymmetrical stabilization exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2016to 7 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- X-ray shows a cobb angle of 10 degrees or higher.
- Patients 8 and older.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Kyungji-do, 13620
About this study
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.
Read the 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
- Conditions
- Idiopathic Scoliosis
- Being tested
- asymmetrical stabilization exercise
- Keywords
- surface EMG, cobb angle, exercise, Spinal Curvatures
- Medical subject headings
- Motor Activity, Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asymmetrical stabilization exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| asymmetrical stabilization exercise group | Experimental | 'asymmetrical stabilization exercise' patient learn asymmetrical stabilization exercise according to the asymmetrical paraspinal muscles weakness and curve type Receives: Behavioral: asymmetrical stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Scoliosis Research Society-22(SRS-22)
questionnaire for evaluating quality of life in patients with idiopathic scoliosis
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start22 Dec 2016
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Annual evaluation after educating asymmetrical stabilization exercise. Cohort study.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ju Seok Ryu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ju Seok Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675984
- Sponsor's protocol ID
- B-1701/378-103
- Status last verified
- Jul 2020
- First submitted
- 10 Sep 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)
- ClinicalTrials.gov ID
- NCT03675984
- Acronym / sponsor ID
- B-1701/378-103
- Conditions
- Idiopathic Scoliosis
- Keywords
- surface EMG, cobb angle, exercise, Spinal Curvatures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ju Seok RyuUniversity, hospital or other
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Annual evaluation after educating asymmetrical stabilization exercise. Cohort study.
| Arm | Type | Receives |
|---|---|---|
| asymmetrical stabilization exercise group | Experimental | Behavioral: asymmetrical stabilization exercise'asymmetrical stabilization exercise' patient learn asymmetrical stabilization exercise according to the asymmetrical paraspinal muscles weakness and curve type |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- X-ray shows a cobb angle of 10 degrees or higher.
- Patients 8 and older.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| asymmetrical stabilization exerciseExercise 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. | Behavioural | asymmetrical stabilization exercise group |
Primary outcome
Cobb angle
Time frame: through study completion, an average of 6 months
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
1 secondary outcome
Scoliosis Research Society-22(SRS-22)
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asymmetrical stabilization exercise in people with Idiopathic Scoliosis, run by Ju Seok Ryu at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020; AzTrials last refreshed its copy on 4 Nov 2026.