Scoliosis IdiopathicNCT03497520
The Effect of Asymmetric Spinal Stabilization Exercise on Scoliosis
A study testing asymmetric spinal stabilization exercise in people with Scoliosis Idiopathic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of asymmetric spinal stabilization exercise on scoliosis Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- asymmetric spinal stabilization exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2018to Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- who have idiopathic scoliosis, showing at Cobb's angle over 10 degrees on X-ray
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
The purpose of this study is to evaluate the effect of asymmetric spinal stabilization exercise on scoliosis
Read the 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
- Conditions
- Scoliosis Idiopathic
- Being tested
- asymmetric spinal 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.
asymmetric spinal stabilization exerciseBehavioural
The patients were educated to strengthening weakness side of spinal muscle, as asymmetric spinal stabilization exercise(ASSE)
- before teach ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity
- after perform ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity
| Study group | Role | What they receive |
|---|---|---|
| scoliosis patients | Experimental | scoliosis patients who have cobb angle over 10 degree perform asymmetric spinal stabilization exercise Receives: Behavioral: asymmetric spinal stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
cobb angle
measure lateral curve of vertebra on spine x-ray AP view
Measured: through study completion, an average of 6 months
Apical vertebral rotation
angle of trunk rotation in Adam's test
Measured: through study completion, an average of 1 year
surface electromyography
surface muscle contraction of bilateral spinal muscle on T7, T12, L3
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Scoliosis Research Society-22(SRS-22) quastionnaire
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start29 Mar 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Hospital
- Investigators
- Jusuk Ryu, M.D. PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497520
- Sponsor's protocol ID
- B-1701/377-305
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Asymmetric Spinal Stabilization Exercise on Scoliosis
- ClinicalTrials.gov ID
- NCT03497520
- Acronym / sponsor ID
- B-1701/377-305
- Conditions
- Scoliosis Idiopathic
- Keywords
- surface EMG, cobb angle, exercise, Spinal Curvatures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Apr 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.
The purpose of this study is to evaluate the effect of asymmetric spinal stabilization exercise on scoliosis
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| scoliosis patients | Experimental | Behavioral: asymmetric spinal stabilization exercisescoliosis patients who have cobb angle over 10 degree perform asymmetric spinal stabilization exercise |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- who have idiopathic scoliosis, showing at Cobb's angle over 10 degrees on X-ray
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| asymmetric spinal stabilization exerciseThe patients were educated to strengthening weakness side of spinal muscle, as asymmetric spinal stabilization exercise(ASSE) * before teach ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity * after perform ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity | Behavioural | scoliosis patients |
Primary outcome
cobb angle
Time frame: through study completion, an average of 6 months
measure lateral curve of vertebra on spine x-ray AP view
Apical vertebral rotation
Time frame: through study completion, an average of 1 year
angle of trunk rotation in Adam's test
surface electromyography
Time frame: through study completion, an average of 6 months
surface muscle contraction of bilateral spinal muscle on T7, T12, L3
1 secondary outcome
Scoliosis Research Society-22(SRS-22) quastionnaire
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jusuk Ryu, M.D. PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asymmetric spinal stabilization exercise in people with Scoliosis Idiopathic, run by Seoul National University Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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?
Results are not available in the source record.
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). The study lists 3 primary outcomes in all. 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 19 Apr 2024.