Clinical Trial: Efficacy of Masticatory Rehabilitation Using Rice Crackers for Patients with Eating and Swallowing Disorders: An Assessor-Blinded Randomized Controlled Trial (Japan)

Tokyo, June 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061802) titled 'Efficacy of Masticatory Rehabilitation Using Rice Confectionery for Patients with Eating and Swallowing Disorders' on June 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Post-stroke dysphagia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate whether masticatory rehabilitation using rice crackers (SakuSaku Reha) improves masticatory function in post-stroke inpatients consuming texture-modified diets. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Masticatory rehabilitation using rice crackers (SakuSaku Reha) is implemented. Interventions/Control_2 - Standard dysphagia rehabilitation are implemented.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Post-stroke patients hospitalized at our institution who received dental consultation during their stay.

Patients prescribed with dysphagia rehabilitation (rehabilitation for feeding and swallowing function).

Patients consuming modified diets (e.g., pureed or minced-and-thickened diets) with a Food Intake Level Scale (FILS) score of 7 or 8.

Patients who tested positive on the SakuSaku-test. Key exclusion criteria - Patients who are unable to understand simple instructions.

Patients without posterior occlusal support (Eichner classification B4 and C; patients with Eichner A1 to B3 are included).

Patients with structural problems or pain during mastication, such as oral cancer or ill-fitting dentures.

Patients who experienced aspiration during the SakuSaku-test.

Patients who do not provide consent to participate in the study. Target Size - 44

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 12 Month 12 Day Date of IRB - 2024 Year 12 Month 12 Day Anticipated trial start date - 2025 Year 10 Month 16 Day Last follow-up date - 2026 Year 12 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070721

Disclaimer: Curated by HT Syndication.