Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06013254
Other study ID # TÜTF-BAEK 2021/214
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2021
Est. completion date November 20, 2022

Study information

Verified date August 2023
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date November 20, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
sour liquid
applying lemon juice

Locations

Country Name City State
Turkey Trakya University Faculty of Medicine Edirne

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Enrolling by invitation NCT06074081 - Comparison of 4-weeks of Motor Relearning Program and Mirror Therapy in Improving Upper Limb Motor Function in Stroke Patients. N/A
Terminated NCT04039178 - Efficacy of EMF BCI Based Device on Acute Stroke N/A
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT03477188 - The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke. N/A
Recruiting NCT05065216 - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) Phase 2/Phase 3
Recruiting NCT02677415 - Impact of Anesthesia Type on Outcome in Patients With Acute Ischemic Stroke (AIS) Undergoing Endovascular Treatment N/A
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Completed NCT01210729 - Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke Phase 2
Recruiting NCT00785343 - Study of Robot-assisted Arm Therapy for Acute Stroke Patients Phase 1
Completed NCT04779710 - How Does Dysphagia Assessment in Acute Stroke Affect Pneumonia?
Active, not recruiting NCT03635749 - Intensive Medical Therapy for High-risk Intracranial or Extracranial Atherosclerosis Phase 3
Recruiting NCT06149754 - BraiN20® Monitoring in Acute Stroke Undergoing Thrombectomy
Recruiting NCT04491695 - Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke Phase 2/Phase 3
Recruiting NCT04283760 - Investigation of the Reliability and Validity of the Movement Imagination Questionnaire - Revised Second in Acute Stroke Patients
Recruiting NCT05454397 - A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients
Completed NCT04488692 - Early Functional Training in Acute Stroke Inpatient Ward N/A
Recruiting NCT04214522 - Reliability and Validity of the Kinesthetic and Visual Imagery Questionnaire in Acute Stroke Patients
Not yet recruiting NCT04157231 - Essential Acute Stroke Care in Low Resource Settings: a Pilot studY N/A
Recruiting NCT05469438 - IMAS Optimization and Applicability in an Acute Stroke Setting.