- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06013254
Effect of Sour Liquid On Swallowing Function of the Patients With Stroke
Effect of Sour Liquid On Swallowing Function of the Patients With Post-Stroke Dysphagia
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Edirne, Turkey, 22030
- Trakya University Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
applying lemon juice
|
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
swallowing assessments using the Gugging Swallowing Screen (GUSS) score
Time Frame: initial assessment, 7th day assessment, 30th day assessment
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sezgin Kehaya, MD, Doctor of Neurology Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TÜTF-BAEK 2021/214
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Stroke
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Cidat, S.A. de C.V.El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUnknownStroke | Stroke, Acute | Cerebral Stroke | Cerebrovascular Stroke | Cerebrovascular Accident, AcuteMexico
-
Centre hospitalier de l'Université de Montréal...Not yet recruitingStroke, Acute ThromboticCanada
-
University of MiamiTemporarily not availableStroke, Ischemic | Stroke, Acute | Mesenchymal Stem Cells | Acute Ischemic Stroke | Stroke/Brain AttackUnited States
-
University Hospital, MontpellierNot yet recruiting
-
Capital Medical UniversityRecruitingAcute Stroke | Ischemic Stroke, AcuteChina
-
Chonbuk National University HospitalKorean Society of Neurosonology; Ministry of SMEs and Startups, Republic of... and other collaboratorsCompleted
-
Dongzhimen Hospital, BeijingThe Second Hospital of Hebei Medical University; Peking University Third Hospital and other collaboratorsRecruitingStroke, Ischemic | Stroke, Acute | Acute Ischemic StrokeChina
-
National Taiwan University HospitalCompleted
-
University of EdinburghNHS LothianRecruiting
Clinical Trials on sour liquid
-
University of OsloThe Research Council of Norway; TineCompletedHealthy | Obesity | OverweightNorway
-
University of PernambucoRecruitingTo Evaluate the Effect of Supplementation of Citrus Aurantium in Active IndividualsBrazil
-
American University of Beirut Medical CenterNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)RecruitingNicotine Dependence | Nicotine Vaping | Nicotine AddictionLebanon
-
Purdue UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHigh and Increasing Contribution of Energy From Beverages in the Diet May Enhance Positive Energy Balance and Weight GainUnited States
-
Seagen Inc.CompletedAnaplastic Large-Cell LymphomaUnited States
-
University of DebrecenEnrolling by invitation
-
Boston Children's HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingDysphagia | Aspiration | Brief Resolved Unexplained Event (BRUE) | Apparent Life Threatening Event (ALTE)United States
-
Dana-Farber Cancer InstituteHarvard University; Conquer Cancer Foundation; Alex's Lemonade Stand Foundation; Sam Day FoundationRecruitingEwing Sarcoma of Bone | Ewing Sarcoma | Peripheral Primitive Neuroectodermal Tumor | Peripheral Primitive Neuroectodermal Tumor of Bone | High-grade Osteosarcoma | Ewing Sarcoma of Soft Tissue | Peripheral Primitive Neuroectodermal Tumor of Soft TissueUnited States
-
Abbott NutritionNot yet recruiting
-
Columbia UniversityCompletedBladder Cancer | ComplicationsUnited States