Tokyo, Jan. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060229) titled 'Effects of Swallowing Rehabilitation Using an Interferential Current-Type Low-Frequency Electrical Stimulation Device' on Jan. 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Gunma Paz University

Condition: Condition - Dysphagia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to compare the effects of electrical stimulation intervention using an interferential current-type low-frequency therapy device (GentleStim EX) on

Swallowing-related muscle strength (neck muscle strength, maximum tongue pressure) Swallowing function (FILS, FOIS)

in adult patients with dysphagia, compared to conventional swallowing rehabilitation methods. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Electrical Stimulation Using the GentleStim EX (FGM01) Interference Current Type Low-Frequency Therapy Device In addition to the above Conventional Swallowing Rehabilitation (Head Elevation Training, Neck Resistance Exercise Training, Tongue Resistance Exercise Training, Respiratory Muscle Training, etc.) Interventions/Control_2 - Only conventional swallowing rehabilitation is performed. Conventional methods of dysphagia rehabilitation

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adults with dysphagia at Numata Neurosurgery and Cardiology Hospital Individuals receiving dysphagia rehabilitation Individuals who received a thorough explanation of the research content and provided written consent Key exclusion criteria - Implantable electronic medical device (pacemaker, etc.) wearers Pregnant women and new mothers Individuals with poor skin condition on the neck Individuals who meet the contraindications listed in the device package insert Target Size - 84

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 29 Day Anticipated trial start date - 2026 Year 01 Month 17 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068888

Disclaimer: Curated by HT Syndication.