Randomized crossover open-label trial to evaluate the swallowability of different formulations (conventional tablets, OD tablets, mini-tablets, and foam formulations) in patients with post-stroke dysphagia.

未提供0 个研究点目标入组 16 人开始时间: 待定

适应症

试验速览

暂无简介。

•Post-stroke patients evaluated by a speech-language-hearing therapist as having mild dysphagia.
•Patients who are able to consume fluids or meals and are scheduled to undergo videoendoscopic evaluation of swallowing.
•Patients with a Repetitive Saliva Swallowing Test (RSST) score of 1 to
•Patients with an HDSR score of 21 or higher, or those without a diagnosis of dementia prior to admission.
•Patients who have provided written informed consent to participate in this study.
•Patients for whom consent has been obtained from the attending physician of the primary department at the time of admission.

•Patients who do not meet the criteria for starting oral intake set by the Japanese Society of Dysphagia Rehabilitation.
•Patients with dementia.
•Patients aged 80 years or older.
•Patients with a PAS score of 5 or higher during routine examination (patients with decreased pharyngeal sensation).
•Patients with an RSST score of 0, or 4 or more.
•Patients with difficulty in oral transit due to limited tongue range of motion.
•Patients for whom safe examination cannot be performed based on the Hyodo score during videoendoscopic evaluation of swallowing.
•Patients with self-reported oral abnormalities such as stomatitis.
•Patients with a history of allergy to the additives in the formulations.
•Patients with communication difficulties.
•Patients judged unable to safely undergo the study based on the results of the videoendoscopic evaluation of swallowing (e.g., those with nasal cavity abnormalities or severe body movements).
•Patients judged inappropriate for study participation by the principal investigator, sub-investigators, or the attending physician of the primary department at the time of admission.

发起方

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