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Clinical Trials/NCT07455279
NCT07455279Not yet recruitingNot Applicable

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

Seoul National University Bundang Hospital1 site in 1 country30 target enrollmentStarted: March 9, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
Electromyography-based activation patterns of swallowing-related muscles (orbicularis oris, submental, and hyoid muscles)

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
2 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 -

Arms & Interventions

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

JeeHyun Suh

Professor

Seoul National University Bundang Hospital

Study Sites (1)

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