Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059526) titled 'Effect of exercise using a sRED' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - National Center for Geriatrics and Gerontology

Condition: Condition - Dysphagia due to insufficient contraction of the pharyngeal constrictor muscles during swallowing Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the training effect of using a pharyngeal contraction training tool for patients with dysphagia Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - With the sRED wrapped around the neck, inflate the balloon to compress the thyroid cartilage, and the patients perform swallowing. If the patients cannot swallow due to lack of saliva, inject a small amount of a safe liquid or thickened water into the mouth and attempt swallowing. The patients perform the training 1-3 sets per day; each set consists of 30 swallows.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older with dysphagia and insufficient contraction of the pharyngeal constrictor muscles during swallowing Key exclusion criteria - 1) Patients who cannot adequately follow the therapist's instructions due to cognitive impairment or higher brain dysfunction 2) Patients with malignant tumors at the application site 3) Patients with skin abnormalities such as eczema or trauma at the throat area 4) Patients unable to recognize throat pain, discomfort, breathing abnormalities, or blood flow abnormalities 5) Patients with allergic symptoms to natural rubber Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 16 Day Date of IRB - 2025 Year 10 Month 16 Day Anticipated trial start date - 2025 Year 10 Month 24 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068092

Disclaimer: Curated by HT Syndication.