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Effect of Sour Liquid On Swallowing Function of the Patients With Stroke

Primary Purpose

Acute Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sour liquid
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Stroke focused on measuring acute stroke, dysphagia, swallowing function, sour taste

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trakya University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

4 ml of freshly squeezed lemon juice with a pH of 2.8 at room temperature was administered under the supervision of the physician before breakfast, lunch, and dinner for patients with ischemic stroke. For patients with severe swallowing disorders according to the GUSS, lemon juice was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the lemon juice out of their mouths. This procedure was continued for seven days.

4 ml of room temperature water was administered under the supervision of the physician before breakfast, lunch, and dinner. For patients with severe swallowing disorders according to the GUSS, water was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the water out of their mouths. This procedure was continued for seven days.

Outcomes

Primary Outcome Measures

swallowing assessments using the Gugging Swallowing Screen (GUSS) score
improve the swallowing disorders of patients who have experienced acute stroke through the administration of sour taste. patients in both the intervention and control groups underwent advanced swallowing assessments using the GUSS. Gugging Swallowing Screen (GUSS)consists of two parts including an indirect swallowing test with three subtests, and a direct swallowing test with four subtests. Evaluation is made on a scale of 0-20 as follows: 0-9 points indicate severe swallowing disorder with high risk of aspiration, 10-14 points indicate moderate swallowing disorder with moderate risk of aspiration, 15-19 points indicate mild swallowing disorder with low risk of aspiration, and 20 points indicate no swallowing disorder.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
August 26, 2023
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT06013254
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
acute stroke, dysphagia, swallowing function, sour taste

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
4 ml of freshly squeezed lemon juice with a pH of 2.8 at room temperature was administered under the supervision of the physician before breakfast, lunch, and dinner for patients with ischemic stroke. For patients with severe swallowing disorders according to the GUSS, lemon juice was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the lemon juice out of their mouths. This procedure was continued for seven days.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
4 ml of room temperature water was administered under the supervision of the physician before breakfast, lunch, and dinner. For patients with severe swallowing disorders according to the GUSS, water was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the water out of their mouths. This procedure was continued for seven days.
Intervention Type
Dietary Supplement
Intervention Name(s)
sour liquid
Intervention Description
applying lemon juice
Primary Outcome Measure Information:
Title
swallowing assessments using the Gugging Swallowing Screen (GUSS) score
Description
improve the swallowing disorders of patients who have experienced acute stroke through the administration of sour taste. patients in both the intervention and control groups underwent advanced swallowing assessments using the GUSS. Gugging Swallowing Screen (GUSS)consists of two parts including an indirect swallowing test with three subtests, and a direct swallowing test with four subtests. Evaluation is made on a scale of 0-20 as follows: 0-9 points indicate severe swallowing disorder with high risk of aspiration, 10-14 points indicate moderate swallowing disorder with moderate risk of aspiration, 15-19 points indicate mild swallowing disorder with low risk of aspiration, and 20 points indicate no swallowing disorder.
Time Frame
initial assessment, 7th day assessment, 30th day assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sezgin Kehaya, MD
Organizational Affiliation
Doctor of Neurology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trakya University Faculty of Medicine
City
Edirne
ZIP/Postal Code
22030
Country
Turkey

12. IPD Sharing Statement

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Effect of Sour Liquid On Swallowing Function of the Patients With Stroke

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