Surface Electromyographic Analysis of Normal Swallowing in Children: An Exploratory Study

NCT07455279 | Not Yet Recruiting

• 1 other identifier: B-2602-1206-302
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Swallowing Muscle Activation Patterns in Children; Normal Pediatric Swallowing Physiology; Swallowing Function

Keywords

Pediatric Swallowing; Swallowing Physiology; Surface Electromyography; Swallowing Muscle Activation; Normative Data; Deglutition; Developmental Physiology

Outcome Measures

Primary Outcomes (1)

• 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

  Single assessment at baseline visit

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Refusal to provide consent for participation in the study
• Refusal to undergo the study procedures or assessments

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Central Study Contacts

JINJU LEE, MSc

CONTACT

+82 10-3377-5741; duyo98@daum.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

KR (1)