Idiopathic ScoliosisNCT05333796
The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography
A study testing gait with leg length discrepancy in people with Idiopathic Scoliosis, 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 back muscle activations on idiopathic scoliosis Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- gait with leg length discrepancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2022to 12 Dec 2023
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children (5 to 12 years old)
Who cannot join
- 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
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 back muscle activations on idiopathic scoliosis
Read the 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)
- Conditions
- Idiopathic Scoliosis
- Being tested
- gait with leg length discrepancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait with leg length discrepancyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children (5 to 12 years old) | Experimental | Not described Receives: Behavioral: gait with leg length discrepancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
surface electromyography
surface muscle contraction of bilateral back muscles
- bilateral spinal muscles on T6, T12, L3
- bilateral quadratus lumborum muscles
- bilateral iliopsoas muscles
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start30 May 2022
- Primary completion28 Feb 2023
- Study completion12 Dec 2023
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.
- 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
- 39 participants (actual)
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
- NCT05333796
- Sponsor's protocol ID
- B-2203-747-302
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography
- ClinicalTrials.gov ID
- NCT05333796
- Acronym / sponsor ID
- B-2203-747-302
- Conditions
- Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 19 Apr 2022 (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 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children (5 to 12 years old) | Experimental | Behavioral: gait with leg length discrepancy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children (5 to 12 years old)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| gait with leg length discrepancyAfter 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. | Behavioural | Healthy children (5 to 12 years old) |
Primary outcome
surface electromyography
Time frame: 20 minutes
surface muscle contraction of bilateral back muscles * bilateral spinal muscles on T6, T12, L3 * bilateral quadratus lumborum muscles * bilateral iliopsoas muscles
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 19 Apr 2024.
Related trials for Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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 gait with leg length discrepancy in people with Idiopathic Scoliosis, 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 5 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 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?
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?
surface electromyography (time frame: 20 minutes). 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.