Dysphagia following stroke Stroke, Dysphagia
Conditions
Interventions
Patients will receive four types of formulations (conventional tablet, orally disintegrating tablet [ODT], mini-tablet, and foam formulation) one by one, placed on the back of the tongue using a spoon
D26.255
Formulation, Swallowability, Foam formulation
Sponsors
Yamamoto Mariko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Post-stroke patients evaluated by a speech-language-hearing therapist as having mild dysphagia. 2. Patients who are able to consume fluids or meals and are scheduled to undergo videoendoscopic evaluation of swallowing. 3. Patients with a Repetitive Saliva Swallowing Test (RSST) score of 1 to 3. 4. Patients with an HDSR score of 21 or higher, or those without a diagnosis of dementia prior to admission. 5. Patients who have provided written informed consent to participate in this study. 6. Patients for whom consent has been obtained from the attending physician of the primary department at the time of admission.
Exclusion criteria
Exclusion criteria: 1. Patients who do not meet the criteria for starting oral intake set by the Japanese Society of Dysphagia Rehabilitation. 2. Patients with dementia. 3. Patients aged 80 years or older. 4. Patients with a PAS score of 5 or higher during routine examination (patients with decreased pharyngeal sensation). 5. Patients with an RSST score of 0, or 4 or more. 6. Patients with difficulty in oral transit due to limited tongue range of motion. 7. Patients for whom safe examination cannot be performed based on the Hyodo score during videoendoscopic evaluation of swallowing. 8. Patients with self-reported oral abnormalities such as stomatitis. 9. Patients with a history of allergy to the additives in the formulations. 10. Patients with communication difficulties. 11. 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). 12. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale (VAS) score for overall ease of swallowing | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of swallowing attempts to ingest the formulation, Observation of the swallowing process using videoendoscopy | — |
Contacts
Public ContactMariko Yamamoto
Department of Pharmacy, Chutoen General Medical Center
Outcome results
None listed