Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
NCT Number: NCT07455279
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.
Trial opening soon.
Get Notified2 year–10 year
All sexes
Observational
Seongnam-si, Gyeonggi-do, 13620, South Korea
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
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.
Participants will consume 5-10 cc of liquid using a straw while sEMG signals are recorded from the same muscle groups.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Contact information is provided by the study sponsor or research team.
Seoul National University Bundang Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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