--- title: Effectiveness of NMES in Swallowing Rehabilitation in Children With CP nct_id: NCT07329387 overall_status: COMPLETED phase: NA sponsor: Necmettin Erbakan University study_type: INTERVENTIONAL primary_condition: Cerebral Palsy (CP) countries: Turkey (Türkiye) canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07329387.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07329387" ct_last_update_post_date: 2026-01-09 last_seen_at: "2026-05-12T06:38:36.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Effectiveness of NMES in Swallowing Rehabilitation in Children With CP **Official Title:** Electrophysiological Investigation of the Effectiveness of NMES Swallowing Difficulty Rehabilitation in Children With Cerebral Palsy **NCT ID:** [NCT07329387](https://clinicaltrials.gov/study/NCT07329387) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 26 - **Lead Sponsor:** Necmettin Erbakan University - **Conditions:** Cerebral Palsy (CP) - **Start Date:** 2018-05-01 - **Completion Date:** 2020-01-02 - **CT.gov Last Update:** 2026-01-09 ## Brief Summary 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. ## Detailed Description 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 ## Eligibility - **Minimum age:** 4 Years - **Maximum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **NMES** (EXPERIMENTAL) — In addition to the conventional swallowing rehabilitation approaches, neuromuscular electrical stimulation (NMES) was applied to the experimental group, while Sham-NMES was administered to the control group. For NMES applied to the suprahyoid muscle group, a frequency of 80 Hz with a pulse duration of 300-400 microseconds was used, and VitalStim therapy was administered for 40 minutes per session. In the Sham-NMES application, electrodes were placed on the same anatomical region, and the same amplitude and frequency settings were used as in the NMES protocol; however, no electrical current was delivered during the 40-minute session. To address ethical considerations, participants in the Sham-NMES group received 12 sessions of active NMES after completion of data collection, thereby minimizing potential bias. - **Sham-NMES** (SHAM_COMPARATOR) — Sham NMES (Sham Neuromuscular Electrical Stimulation) is a placebo version of neuromuscular electrical stimulation used in clinical studies ## Interventions - **Neuromuscular Electrical Stimulation** (DEVICE) — 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 Stimulation** (DEVICE) — Sham NMES involves applying the electrical stimulation device without delivering therapeutic current, serving as a placebo control in randomized clinical trials ## Primary Outcomes - **Pedi-EAT-10** _(time frame: Baseline (pre-intervention))_ — 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) ## Locations (1) - Nezahat Keleşoğlu Faculty of Health Sciences, Konya, Meram, Turkey (Türkiye) ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.nezahat keleşoğlu faculty of health sciences|konya|meram|turkey (türkiye)` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07329387.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07329387* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*