Normal Pediatric Swallowing PhysiologyNCT07455279
Surface Electromyographic Analysis of Normal Swallowing in Children: An Exploratory Study
An observational study of Normal Pediatric Swallowing Physiology and Swallowing Muscle Activation Patterns in Children, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This exploratory clinical trial aims to investigate the mechanism of sequential muscle contractions during normal swallowing processes, including spoon, straw, and cup feeding, in children aged 2 to under 10 years without swallowing disorders. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Pediatric Swallowing Physiology, Swallowing Muscle Activation Patterns in Children, Swallowing Function
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2026to 31 Jan 2028
- How long will I take part?
- 1 Day
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric participants aged 2 years to less than 10 years who have not been diagnosed with dysphagia and have no medical conditions known to affect the swallowing process, such as congenital brain lesions or respiratory diseases, will be enrolled. Participants will be recruited from the outpatient and inpatient services of the Department of Rehabilitation Medicine at Seoul National University Bundang Hospital. Both male and female participants will be included.
Who may be able to join
- Children aged 2 to under 10 years
- Children without a diagnosis of dysphagia
- Children without congenital brain lesions or respiratory conditions (e.g., bronchopulmonary dysplasia [BPD], respiratory distress syndrome [RDS]) that may affect the swallowing process
- Children whose legal guardians provide informed consent for participation
- Participants who meet all of the above inclusion criteria
Who cannot join
- Refusal to provide consent for participation in the study
- Refusal to undergo the study procedures or assessments
- Determined by the principal investigator to be unsuitable for participation -Meeting any of the above exclusion criteria -
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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
JINJU LEE, MSc, +82-10-3377-5741, RQ317@snubh.org
About this study
This exploratory clinical trial aims to investigate the mechanism of sequential muscle contractions during normal swallowing processes, including spoon, straw, and cup feeding, in children aged 2 to under 10 years without swallowing disorders. Surface electromyography (sEMG) will be used to evaluate activation patterns of the orbicularis oris, submental, and hyoid muscles during liquid, semi-solid, and solid intake.
The study seeks to characterize the timing, duration, amplitude, and coordination of swallowing-related muscle activity in typically developing children. Findings from this study are expected to provide foundational physiological data to inform the development of pediatric-specific neuromuscular electrical stimulation (NMES) protocols for dysphagia treatment.
Read the detailed description
Background and Rationale
Swallowing is a complex neuromuscular process requiring coordinated and sequential activation of orofacial and suprahyoid muscles. While neuromuscular electrical stimulation (NMES) has been widely applied in adult dysphagia rehabilitation, pediatric-specific physiological data on swallowing muscle activation patterns remain limited. Current clinical practice often extrapolates adult treatment protocols to pediatric populations, despite developmental differences in anatomy, neuromuscular control, and feeding mechanisms.
Understanding the normative sequential activation patterns of swallowing-related muscles in children is essential for developing age-appropriate therapeutic protocols. This study aims to establish baseline physiological data on muscle activation sequencing during various feeding methods in typically developing children.
Study Design
This is an exploratory, single-center clinical study enrolling 30 children aged 2 to under 10 years without diagnosed swallowing disorders. Participants will undergo non-invasive surface electromyography (sEMG) assessments during standardized feeding tasks.
Study Procedures
- Spoon Feeding Mechanism Assessment Participants will consume: 3-5 cc of liquid using a spoon 3-5 cc of yogurt (semi-solid consistency) using a spoon Solid food using a spoon Surface EMG electrodes will be placed over the: Orbicularis oris Submental muscle group Hyoid-related musculature Muscle activation patterns during swallowing will be recorded.
- Straw Feeding Mechanism Assessment Participants will consume 5-10 cc of liquid using a straw while sEMG signals are recorded from the same muscle groups.
- Cup Drinking Mechanism Assessment
Participants will consume 5-10 cc of liquid from a cup with simultaneous sEMG recording.
Data Collection Observational Variables
Name
Age
Birth history (gestational age, birth weight, delivery method)
Sex
Race
Height and weight
Medical history
Surgical history
Medication use
History of pneumonia
Diagnosis of swallowing disorder
Anthropometric Measurements
Distance from mandible midpoint to hyoid bone
Distance between bilateral angles of the mandible
Distance from hyoid bone to clavicle
Bilateral neck width at the level of the thyroid cartilage
Surface Electromyography (sEMG) Outcome Measures
Primary electrophysiological variables include:
Onset latency
Offset latency
Duration of muscle contraction
Peak amplitude
Area Under the Curve (AUC)
The primary outcome measure is the sequential activation pattern of swallowing-related muscles (orbicularis oris, submental, and hyoid muscles).
Statistical Analysis
Descriptive statistics will be reported as mean ± standard deviation. Normality will be assessed using the Shapiro-Wilk test.
Comparisons of non-nutritive versus nutritive swallowing within the same participant will be analyzed using the Wilcoxon signed-rank test.
Sequential muscle activation order (e.g., onset timing differences among muscles) will be analyzed using the Friedman test.
A p-value < 0.05 will be considered statistically significant.
Expected Significance
This study aims to clarify the physiological mechanisms of sequential muscle activation during swallowing in typically developing children. The findings are expected to provide essential normative data for the development of pediatric-specific NMES protocols for dysphagia treatment. Establishing age-appropriate stimulation parameters may ultimately contribute to more effective and developmentally tailored therapeutic interventions in pediatric populations.
- Conditions
- Normal Pediatric Swallowing Physiology, Swallowing Muscle Activation Patterns in Children, Swallowing Function
- Keywords
- Pediatric Swallowing, Swallowing Physiology, Surface Electromyography, Swallowing Muscle Activation, Normative Data, Deglutition, Developmental Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Pediatric Participants | Children aged 2 to under 10 years without a diagnosis of dysphagia and without medical conditions known to affect the swallowing process. Participants will undergo a single surface electromyography (EMG) assessment during swallowing tasks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography-based activation patterns of swallowing-related muscles (orbicularis oris, submental, and hyoid muscles)
Surface electromyography (EMG) parameters measured during swallowing tasks, including Onset latency (time of muscle contraction onset), Offset latency (time of muscle contraction termination), Duration (duration of muscle contraction), Peak amplitude (maximum amplitude), and Area under the curve (AUC) of the electromyographic signal
Measured: Single assessment at baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start9 Mar 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pediatric Swallowing PhysiologyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JeeHyun Suh, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455279
- Sponsor's protocol ID
- B-2602-1206-302
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surface Electromyographic Analysis of Normal Swallowing in Children: An Exploratory Study
- ClinicalTrials.gov ID
- NCT07455279
- Acronym / sponsor ID
- B-2602-1206-302
- Conditions
- Normal Pediatric Swallowing Physiology, Swallowing Muscle Activation Patterns in Children, Swallowing Function
- Keywords
- Pediatric Swallowing, Swallowing Physiology, Surface Electromyography, Swallowing Muscle Activation, Normative Data, Deglutition, Developmental Physiology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Mar 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 exploratory clinical trial aims to investigate the mechanism of sequential muscle contractions during normal swallowing processes, including spoon, straw, and cup feeding, in children aged 2 to under 10 years without swallowing disorders. Surface electromyography (sEMG) will be used to evaluate activation patterns of the orbicularis oris, submental, and hyoid muscles during liquid, semi-solid, and solid intake.
The study seeks to characterize the timing, duration, amplitude, and coordination of swallowing-related muscle activity in typically developing children. Findings from this study are expected to provide foundational physiological data to inform the development of pediatric-specific neuromuscular electrical stimulation (NMES) protocols for dysphagia treatment.
Detailed description
Background and Rationale
Swallowing is a complex neuromuscular process requiring coordinated and sequential activation of orofacial and suprahyoid muscles. While neuromuscular electrical stimulation (NMES) has been widely applied in adult dysphagia rehabilitation, pediatric-specific physiological data on swallowing muscle activation patterns remain limited. Current clinical practice often extrapolates adult treatment protocols to pediatric populations, despite developmental differences in anatomy, neuromuscular control, and feeding mechanisms.
Understanding the normative sequential activation patterns of swallowing-related muscles in children is essential for developing age-appropriate therapeutic protocols. This study aims to establish baseline physiological data on muscle activation sequencing during various feeding methods in typically developing children.
Study Design
This is an exploratory, single-center clinical study enrolling 30 children aged 2 to under 10 years without diagnosed swallowing disorders. Participants will undergo non-invasive surface electromyography (sEMG) assessments during standardized feeding tasks.
Study Procedures
- Spoon Feeding Mechanism Assessment Participants will consume: 3-5 cc of liquid using a spoon 3-5 cc of yogurt (semi-solid consistency) using a spoon Solid food using a spoon Surface EMG electrodes will be placed over the: Orbicularis oris Submental muscle group Hyoid-related musculature Muscle activation patterns during swallowing will be recorded.
- Straw Feeding Mechanism Assessment Participants will consume 5-10 cc of liquid using a straw while sEMG signals are recorded from the same muscle groups.
- Cup Drinking Mechanism Assessment
Participants will consume 5-10 cc of liquid from a cup with simultaneous sEMG recording.
Data Collection Observational Variables
Name
Age
Birth history (gestational age, birth weight, delivery method)
Sex
Race
Height and weight
Medical history
Surgical history
Medication use
History of pneumonia
Diagnosis of swallowing disorder
Anthropometric Measurements
Distance from mandible midpoint to hyoid bone
Distance between bilateral angles of the mandible
Distance from hyoid bone to clavicle
Bilateral neck width at the level of the thyroid cartilage
Surface Electromyography (sEMG) Outcome Measures
Primary electrophysiological variables include:
Onset latency
Offset latency
Duration of muscle contraction
Peak amplitude
Area Under the Curve (AUC)
The primary outcome measure is the sequential activation pattern of swallowing-related muscles (orbicularis oris, submental, and hyoid muscles).
Statistical Analysis
Descriptive statistics will be reported as mean ± standard deviation. Normality will be assessed using the Shapiro-Wilk test.
Comparisons of non-nutritive versus nutritive swallowing within the same participant will be analyzed using the Wilcoxon signed-rank test.
Sequential muscle activation order (e.g., onset timing differences among muscles) will be analyzed using the Friedman test.
A p-value < 0.05 will be considered statistically significant.
Expected Significance
This study aims to clarify the physiological mechanisms of sequential muscle activation during swallowing in typically developing children. The findings are expected to provide essential normative data for the development of pediatric-specific NMES protocols for dysphagia treatment. Establishing age-appropriate stimulation parameters may ultimately contribute to more effective and developmentally tailored therapeutic interventions in pediatric populations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Pediatric Participants | – | –Children aged 2 to under 10 years without a diagnosis of dysphagia and without medical conditions known to affect the swallowing process. Participants will undergo a single surface electromyography (EMG) assessment during swallowing tasks. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric participants aged 2 years to less than 10 years who have not been diagnosed with dysphagia and have no medical conditions known to affect the swallowing process, such as congenital brain lesions or respiratory diseases, will be enrolled. Participants will be recruited from the outpatient and inpatient services of the Department of Rehabilitation Medicine at Seoul National University Bundang Hospital. Both male and female participants will be included.
Key inclusion criteria (5 listed)
- Children aged 2 to under 10 years
- Children without a diagnosis of dysphagia
- Children without congenital brain lesions or respiratory conditions (e.g., bronchopulmonary dysplasia [BPD], respiratory distress syndrome [RDS]) that may affect the swallowing process
- Children whose legal guardians provide informed consent for participation
- Participants who meet all of the above inclusion criteria
Key exclusion criteria (3 listed)
- Refusal to provide consent for participation in the study
- Refusal to undergo the study procedures or assessments
- Determined by the principal investigator to be unsuitable for participation -Meeting any of the above exclusion criteria -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electromyography-based activation patterns of swallowing-related muscles (orbicularis oris, submental, and hyoid muscles)
Time frame: Single assessment at baseline visit
Surface electromyography (EMG) parameters measured during swallowing tasks, including Onset latency (time of muscle contraction onset), Offset latency (time of muscle contraction termination), Duration (duration of muscle contraction), Peak amplitude (maximum amplitude), and Area under the curve (AUC) of the electromyographic signal
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 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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.
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 Normal Pediatric Swallowing Physiology and Swallowing Muscle Activation Patterns in Children, run by Seoul National University Bundang 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 5 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 6 Mar 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 JINJU LEE, MSc (+82 10-3377-5741, duyo98@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography-based activation patterns of swallowing-related muscles (orbicularis oris, submental, and hyoid muscles) (time frame: Single assessment at baseline visit). 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 6 Mar 2026.