Clinical trial NCT06013254: Effect of Sour Liquid On Swallowing Function of the Patients With Stroke
Official title: Effect of Sour Liquid On Swallowing Function of the Patients With Post-Stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: acute stroke
dysphagia
swallowing function
sour taste
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to evaluate the effect of early administration of sour liquid on swallowing function of patients with post-stroke dysphagia.

Hypothesis of the study were; H0: The sour liquid given early to patients with post-stroke dysphagia does not have an effect on swallowing function H1: The sour liquid given early to patients with post-stroke dysphagia has an effect on swallowing function The data of the study were collected using the "Personal Information Form," "Standard Swallowing Test," "Gagging Swallowing Screening Test (GUSS)," and the " National Institute of Health Stroke Scale (NIHSS)".

Early administration of sour liquid to patients with post-stroke dysphagia was found to have a positive effect on swallowing function.

Detailed description: Background: Untreated and undetected swallowing disorders lead to increased morbidity and mortality in acute stroke patients due to inadequate nutrition, dehydration, and aspiration pneumonia leading to prolonged hospital stays, decreased functionality, and increased long-term care needs. The aim of this study was to evaluate the effect of early administration of sour liquid on swallowing function of patients with post-stroke dysphagia.

Materials and methods: This study was a randomized controlled trial, which was conducted with 95 patients with confirmed diagnosis of ischemic stroke and dysphagia, admitted to the neurology department of a university hospital. The intervention group (n=47) received 4 ml of room temperature lemon juice, while the control group (n=48) received 4 ml of room temperature water before breakfast, lunch, and dinner for a duration of 7 days. The Standard Swallowing Test, Gagging Swallowing Screen, and National Institutes of Health Stroke Scale were applied. Swallowing function and stroke severity were assessed at initial assessment, at the end of the 7th and 30th days.

Eligibility criteria: Inclusion Criteria:

* diagnosed with ischemic stroke,
* had not completed the first 72 hours after diagnosis,
* developed swallowing disorders,
* volunteered to participate in the study

Exclusion Criteria:

* diagnosed hemorrhagic stroke,
* had completed the first 72 hours after diagnosis,
* not developed swallowing disorders,
* not volunteered to participate in the study

Primary outcomes:
measure: swallowing assessments using the Gugging Swallowing Screen (GUSS) score
timeFrame: initial assessment, 7th day assessment, 30th day assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine
Study officials:
affiliation: Doctor of Neurology Clinic
name: Sezgin Kehaya, MD
role: PRINCIPAL_INVESTIGATOR
References: