Effectiveness of NMES in Swallowing Rehabilitation in Children With CP

Necmettin Erbakan University26 enrolled

Overview

Purpose: The aim is to investigate the effectiveness of NMES in the functional and electrophysiological rehabilitation of swallowing difficulties in dysphagic children with cerebral palsy. Methods: Twenty-six children diagnosed with dysphagia, with a mean age of 7.02±2.40 years, were included in the study and randomly allocated into two groups (NMES,n=16;Sham NMES,n=10). In addition to swallowing rehabilitation, stimulation was applied to the groups. Participants were assessed using the Pediatric Eating Assessment Tool, Penetration-Aspiration Scale, Karaduman Chewing Performance Scale, Swallowing Ability and Function Evaluation and Electrophysiological Evaluation of the Suprahyoid Muscle in four consistencies.

This study has already been completed; however, at the time of the study, registration in the public trial database had not been performed. Since the journal requires a registration number upon submission, we have completed a retrospective registration to fulfill this requirement. The registration reflects the actual study dates and ensures transparency and compliance with publication standard

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy (CP)

Interventions

Neuromuscular Electrical StimulationDEVICE

For NMES applied to the suprahyoid muscle group, a 80 Hertz frequency, with a transition time of 300-400 microseconds, 40 minutes of Vital Stim application was performed

Sham Neuromuscular Electrical StimulationDEVICE

Sham NMES involves applying the electrical stimulation device without delivering therapeutic current, serving as a placebo control in randomized clinical trials

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients whose relatives provided written informed consent * Patients suitable for the planned intervention (assumed from context) Exclusion Criteria: * History of maxillary, head or neck surgery * History of botulinum toxin treatment * Structural oropharyngeal abnormality * Gastroesophageal reflux disease (GERD) * Receiving medical and/or physical therapy for dysphagia * Severe cognitive, visual, auditory, or sensory impairments * Drug use due to seizure or spasticity * Serious pulmonary or cardiac disease * Increased bleeding risk

Outcomes

Primary Outcomes

Pedi-EAT-10

The Pedi-EAT-10 is a caregiver-administered, symptom-based questionnaire designed to screen for signs of oropharyngeal dysphagia in children aged 18 months and older. It consists of 10 items, each rated on a 5-point Likert scale (0 = no problem, 4 = severe problem), assessing observable feeding and swallowing difficulties.Time Frame: Baseline (pre-intervention)

Time frame: Baseline (pre-intervention)