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

NCT06013254 | Completed

• 1 other identifier: TÜTF-BAEK 2021/214
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Keywords

acute stroke; dysphagia; swallowing function; sour taste

Outcome Measures

Primary Outcomes (1)

• 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.

  initial assessment, 7th day assessment, 30th day assessment

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Dietary Supplement: sour liquid

Control group

NO INTERVENTION

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.

Interventions

sour liquid DIETARY_SUPPLEMENT

applying lemon juice

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Faculty of Medicine

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sezgin Kehaya, MD

  Doctor of Neurology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 28, 2023
• Study Start: July 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: November 20, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

TU (1)