Spastic Cerebral Palsy (sCP)NCT07777809
Bilateral Asymmetry of Respiratory Muscle Activity During Breathing in Children With Spastic Cerebral Palsy
An observational study of Spastic Cerebral Palsy (sCP), run by Sahmyook University at 1 site in South Korea.
Trial summary
This observational cross-sectional study investigates the bilateral asymmetry of respiratory muscle activity during breathing in children with spastic cerebral palsy (CP). Children with CP often exhibit structural deformities, which may lead to impaired chest mobility and asymmetric respiratory function. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- Surface Electromyography (sEMG) assessment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 4 to 12 years diagnosed with spastic cerebral palsy who are receiving treatment at a local outpatient rehabilitation center (Easy Rehabilitation Medicine Clinic, Yongin-si, Gyeonggi-do, Republic of Korea).
Who may be able to join
- Children with Gross Motor Function Classification System (GMFCS) Level I or II
- Children with sufficient cognitive ability to understand instructions and voluntarily perform tasks
- Children with a Trunk Appearance Clinical Evaluation (TRACE) score of 4 or higher out of a total of 12 points
Who cannot join
- Children who have undergone orthopedic surgery of the spine or lower extremities, or received botulinum toxin injection treatment within the past 6 months
- Children with acute or chronic respiratory diseases, such as asthma or acute pneumonia
- Children with severe cardiac disorders, intellectual disabilities, or visual and auditory impairments that may interfere with the experiment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Easy Rehabilitation Medicine Clinic
Yongin-si, Gyeonggi-do
jemin Yoo, +82 9936-9957, +82 9936-9957, jemin9957@naver.com
jemin Yoo
About this study
Official title: A Cross-Sectional Study on Bilateral Asymmetry of Respiratory Muscle Activity During Breathing in Children With Spastic Cerebral Palsy: Surface Electromyography Analysis
This observational cross-sectional study investigates the bilateral asymmetry of respiratory muscle activity during breathing in children with spastic cerebral palsy (CP). Children with CP often exhibit structural deformities, which may lead to impaired chest mobility and asymmetric respiratory function. The primary objective is to objectively evaluate the imbalance in the activation of bilateral respiratory muscles (intercostal, external oblique, and sternocleidomastoid) using non-invasive surface electromyography (sEMG). Muscle activity will be measured during resting breathing and active breathing tasks. The findings aim to provide clinical evidence for developing selective respiratory muscle training programs for this population.
Read the detailed description
Children with spastic cerebral palsy frequently experience abnormal muscle tone and motor control issues, leading to structural deformities like scoliosis and pelvic asymmetry. These structural changes can restrict chest wall mobility and cause inefficient, asymmetrical breathing patterns. While ultrasound is often used to assess diaphragm function, it has limitations in evaluating functional respiratory pressure differences based on gross motor function levels and requires high cognitive cooperation. Therefore, this study utilizes surface electromyography (sEMG) to quantify the muscle activation (Root Mean Square, RMS) of respiratory and accessory muscles. The study involves children aged 4 to 12 years with spastic CP. Measurements are conducted in a seated position under two main conditions: 30 seconds of resting breathing and an active breathing task involving blowing a pinwheel or bubbles. An Asymmetry Index (AI) will be calculated to compare the degree of bilateral muscle activation imbalance across the different breathing conditions.
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- Surface Electromyography (sEMG) assessment
- Keywords
- Surface Electromyography, Respiratory Muscle, Asymmetry
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Electromyography (sEMG) assessmentDiagnostic test
Measuring the bilateral activation of respiratory muscles (intercostal, external oblique, and sternocleidomastoid) using sEMG under two conditions: 30 seconds of resting breathing and active breathing tasks (blowing a pinwheel or bubbles).
| Study group | Role | What they receive |
|---|---|---|
| Spastic Cerebral Palsy Group | Children aged 4 to 12 years with spastic cerebral palsy, GMFCS level I-II, and TRACE score of 4 or higher. Receives: Diagnostic Test: Surface Electromyography (sEMG) assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Mean Square (RMS) of Respiratory Muscle Activity
Muscle activation amplitude of the intercostal, external oblique, and sternocleidomastoid muscles measured using surface electromyography (sEMG). The raw sEMG signals are full-wave rectified and smoothed using a 50ms moving window to calculate the RMS values during resting and active breathing tasks.
Measured: Up to 30 minutes (measured once during the single-day assessment session)
Asymmetry Index (AI) of Respiratory Muscle Activation
The asymmetry index will be calculated using the Root Mean Square (RMS) values obtained from surface electromyography (sEMG) . The formula used is (Right RMS - Left RMS) / (Right RMS + Left RMS) X 100 . The index evaluates the percentage of imbalance between the right and left respiratory muscles (intercostal, external oblique, and sternocleidomastoid) during resting breathing and active breathing tasks.
Measured: Up to 30 minutes (measured once during the single-day assessment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral Palsy (sCP)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoo jemin, Sahmyook University
- Investigators
- jemin Yoo, Principal investigator, Sahmyook UniversitySeungwon Lee, Study director, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777809
- Sponsor's protocol ID
- SYU 2026-06-016-001
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not yet been finalized. Future data sharing will depend on the specific requirements of the target journal where the study results will be submitted. If sharing becomes necessary, only fully de-identified data (e.g., sEMG measurements) will be provided upon reasonable request. Any data sharing will be strictly subject to additional review and approval by the Sahmyook University Institutional Review Board to protect the privacy and confidentiality of the pediatric participants with spastic cerebral palsy.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study on Bilateral Asymmetry of Respiratory Muscle Activity During Breathing in Children With Spastic Cerebral Palsy: Surface Electromyography Analysis
- ClinicalTrials.gov ID
- NCT07777809
- Acronym / sponsor ID
- SYU 2026-06-016-001
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- Surface Electromyography, Respiratory Muscle, Asymmetry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Aug 2026 (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.
This observational cross-sectional study investigates the bilateral asymmetry of respiratory muscle activity during breathing in children with spastic cerebral palsy (CP). Children with CP often exhibit structural deformities, which may lead to impaired chest mobility and asymmetric respiratory function. The primary objective is to objectively evaluate the imbalance in the activation of bilateral respiratory muscles (intercostal, external oblique, and sternocleidomastoid) using non-invasive surface electromyography (sEMG). Muscle activity will be measured during resting breathing and active breathing tasks. The findings aim to provide clinical evidence for developing selective respiratory muscle training programs for this population.
Detailed description
Children with spastic cerebral palsy frequently experience abnormal muscle tone and motor control issues, leading to structural deformities like scoliosis and pelvic asymmetry. These structural changes can restrict chest wall mobility and cause inefficient, asymmetrical breathing patterns. While ultrasound is often used to assess diaphragm function, it has limitations in evaluating functional respiratory pressure differences based on gross motor function levels and requires high cognitive cooperation. Therefore, this study utilizes surface electromyography (sEMG) to quantify the muscle activation (Root Mean Square, RMS) of respiratory and accessory muscles. The study involves children aged 4 to 12 years with spastic CP. Measurements are conducted in a seated position under two main conditions: 30 seconds of resting breathing and an active breathing task involving blowing a pinwheel or bubbles. An Asymmetry Index (AI) will be calculated to compare the degree of bilateral muscle activation imbalance across the different breathing conditions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic Cerebral Palsy Group | – | Diagnostic Test: Surface Electromyography (sEMG) assessmentChildren aged 4 to 12 years with spastic cerebral palsy, GMFCS level I-II, and TRACE score of 4 or higher. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 4 to 12 years diagnosed with spastic cerebral palsy who are receiving treatment at a local outpatient rehabilitation center (Easy Rehabilitation Medicine Clinic, Yongin-si, Gyeonggi-do, Republic of Korea).
Key inclusion criteria (3 listed)
- Children with Gross Motor Function Classification System (GMFCS) Level I or II
- Children with sufficient cognitive ability to understand instructions and voluntarily perform tasks
- Children with a Trunk Appearance Clinical Evaluation (TRACE) score of 4 or higher out of a total of 12 points
Key exclusion criteria (3 listed)
- Children who have undergone orthopedic surgery of the spine or lower extremities, or received botulinum toxin injection treatment within the past 6 months
- Children with acute or chronic respiratory diseases, such as asthma or acute pneumonia
- Children with severe cardiac disorders, intellectual disabilities, or visual and auditory impairments that may interfere with the experiment
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 |
|---|---|---|
| Surface Electromyography (sEMG) assessmentMeasuring the bilateral activation of respiratory muscles (intercostal, external oblique, and sternocleidomastoid) using sEMG under two conditions: 30 seconds of resting breathing and active breathing tasks (blowing a pinwheel or bubbles). | Diagnostic test | Spastic Cerebral Palsy Group |
Primary outcome
Root Mean Square (RMS) of Respiratory Muscle Activity
Time frame: Up to 30 minutes (measured once during the single-day assessment session)
Muscle activation amplitude of the intercostal, external oblique, and sternocleidomastoid muscles measured using surface electromyography (sEMG). The raw sEMG signals are full-wave rectified and smoothed using a 50ms moving window to calculate the RMS values during resting and active breathing tasks.
Asymmetry Index (AI) of Respiratory Muscle Activation
Time frame: Up to 30 minutes (measured once during the single-day assessment session)
The asymmetry index will be calculated using the Root Mean Square (RMS) values obtained from surface electromyography (sEMG) . The formula used is (Right RMS - Left RMS) / (Right RMS + Left RMS) X 100 . The index evaluates the percentage of imbalance between the right and left respiratory muscles (intercostal, external oblique, and sternocleidomastoid) during resting breathing and active breathing tasks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not yet been finalized. Future data sharing will depend on the specific requirements of the target journal where the study results will be submitted. If sharing becomes necessary, only fully de-identified data (e.g., sEMG measurements) will be provided upon reasonable request. Any data sharing will be strictly subject to additional review and approval by the Sahmyook University Institutional Review Board to protect the privacy and confidentiality of the pediatric participants with spastic cerebral palsy.
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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.
jemin Yoo principal investigator
Sahmyook University
Seungwon Lee study director
Sahmyook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Cerebral Palsy (sCP), run by Sahmyook University 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jemin Yoo (+82 9936-9957, jemin9957@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Mean Square (RMS) of Respiratory Muscle Activity (time frame: Up to 30 minutes (measured once during the single-day assessment session)). The study lists 2 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 20 Aug 2026.