protocolSection identificationModule nctId: NCT06309056, orgStudyIdInfo id: MP-05-2024-3903, briefTitle: Neuromuscular Electrical Stimulation for Children With Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Sir Mortimer B. Davis - Jewish General Hospital, class: OTHER, descriptionModule briefSummary: This study aims to measure if using neuromuscular electrical stimulation (NMES) effectively improves swallowing, drooling (if applicable), feeding ability, physical growth and quality of life in children with severe dysphagia. This pilot study is for children aged over 18 months old with dysphagia. It aims to investigate a new approach to help children improve their swallowing function. Some published studies have shown that electrical stimulation to muscles involved in swallowing may help children with dysphagia.In this pilot study, NMES will be used. This procedure delivers electrical stimulation to make participants' muscles contract. Electrodes are placed on the skin, over the muscles that help with swallowing, and an electric current is delivered through wires which are connected to a small machine. The current is controlled through a small, handheld device. NMES will be applied to muscles involved in eating, drinking and swallowing. NMES will be applied to the participant alongside their regular treatment. No medications or treatments will be added, modified or discontinued as part of this study.The overall duration of the study per participant will last a total of nine months. For the first three months, the participant will receive the NMES twice a week. There will be no interventions or follow-up appointments scheduled for the following 6 months. Then, there will be a final follow-up meeting 9 months following the start of the intervention to evaluate for lasting changes., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients being followed at the Lethbridge-Layton-Mackay Rehabilitation Centre Salivation Management Clinic and the Dysphagia and Feeding Disturbance Clinic who meet inclusion criteria will be recruited. If caregivers/participants consent to the study, they will be enrolled in the intervention arm. Any potentially eligible participant who declines to participate in the study will be recruited as a control group. These participants will complete the questionnaires at the same timepoints as the interventional group and data from the medical charts will be included in the study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: VitalStim, outcomesModule primaryOutcomes measure: Feeding Intake - Functional Oral Intake Scale, secondaryOutcomes measure: Penetration and Aspiration Scale, secondaryOutcomes measure: Quality of Life - Pediatric Quality of Life Inventory 4.0 Generic Core Scale for Toddlers, Young Children, Children 8-12 years old OR Teenagers., secondaryOutcomes measure: Body Mass Index (kg/m^2), eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False