- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271888
Effect of Mendelsohn Maneuver, Effortful Swallow Training, and the Shaker Exercise on Swallowing Ability Among Dysphagic Patients With Cerebrovascular Accident
December 6, 2025 updated by: Shahlaa Ali, University of Baghdad
Effect of Mendelsohn Maneuver, Effortful Swallow Training, and the Shaker Exercise on Swallowing Ability Among Dysphagic Patients With Cerebrovascular Accident; Randomized Controlled Trial
The study aims to Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Stroke is a significant global challenge for healthcare personnel, as it is a leading cause of disability and death globally.
(1) There are two primary categories of stroke: ischemic and hemorrhagic.
Stroke results in functional disabilities, with 15-30% of individuals experiencing persistent impairments for the duration of their lives.
(2) Stroke is the foremost life-threatening and significant neurological ailment that causes disability, According to predictions from the World Health Organization (WHO), strokes will become the second most common cause of death, behind ischemic heart disease, in both developed and developing nations by 2020.
(3) From a clinical standpoint, stroke occurs when the blood flow to the brain is interrupted due to either a blockage in the main blood vessels produced by thromboembolism or the bursting of arteries.
The majority of strokes, over 85%, are ischemic in nature, resulting from the obstruction of brain arteries due to thrombotic or embolic occlusion.
(4) Neurogenic Dysphagia is a condition where the complex and integrated sensory system is impaired.
It commonly affects individuals with various neurological diseases, particularly acute stroke.
(5) Dysphagia, in fact, is a highly perilous outcome of stroke that can result in lung infections and even mortality among stroke patients.
Hence, it is important to conduct accurate screening, diagnosis, and treatment of dysphagia in patients with acute stroke in order to enhance their quality of life and perhaps mitigate the risk of mortality.
(6)
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shahlaa Ali Talib Street address Wasit, Street 571 City Wasit Ali SAli, Latest degree Master
- Phone Number: +9647722809765
- Email: shahlaa.ali1202a@conursing.uobaghdad.edu.iq
Study Contact Backup
- Name: shahlaa Ali
- Phone Number: +9647722809765
- Email: shahlaa.ali1202a@conursing.uobaghdad.edu.iq
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- An adult patient diagnosed with stroke.
- Patients who had been diagnosed with dysphagia after stroke.
- Patients who are hemodynamically stable, conscious and have adequate cognitive ability to follow simple instructions and able to sit upright for at least 30 minutes.
Exclusion criteria:
- Unstable angina and myocardial infarction)MI(.
- History of seizure.
- Head injury or neurological disease other than stroke, neurosurgery .
- Oral and maxillofacial surgery.
- Dysphagia prior to stroke.
- Gastrointestinal tract upsets.
- Patients who receive hypnotics or sedation.
- critical ill.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Mendelsohn maneuver
Mendelssohn's First, the participant was given a tiny quantity of food or liquid in their mouth.
In cases where there was a possibility of aspiration, dry swallowing was employed.
Second, the thumb and fingers were used to hold the thyroid gland's cartilage.
Thirdly, the dry swallowing technique was mandated by the subject therapist.
Fourth, as the patient swallows, the thyroid cartilage is pulled upward.
Fifth, the patient should hold the thyroid cartilage at its highest moveabl position for two seconds.
Sixth, the person should be at ease.
Seventh, go through steps 1 through 6 again, 15 to 20 times.
|
To achieve single blind in this trial, the participant is kept blinded to their group assignment (interventions and control groups) throughout the study.
The data collector administers the assigned intervention (Mendelsohn maneuver, effortful swallow training, and the Shaker exercise ) without revealing the participant's group assignment.
The researcher retains knowledge of group allocation to ensure Single blind.
Interventions are randomized, and assess Effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on swallowing Ability without knowing the type of maneuvers received, ensuring that participants' expectations do not influence the results.
These procedures reduce the influence of prior expectations and ensure an effective study.
|
|
Other: Effortful Swallow
Effortful Swallow: Patients will be instructed to squeeze hard with all of their tongue muscles when they swallow.
This technique will be performed twice daily, in the morning and in the evening for five consecutive days.
Dysphagia exercises will be carried out five days a week for two weeks.
|
To achieve single blind in this trial, the participant is kept blinded to their group assignment (interventions and control groups) throughout the study.
The data collector administers the assigned intervention (Mendelsohn maneuver, effortful swallow training, and the Shaker exercise ) without revealing the participant's group assignment.
The researcher retains knowledge of group allocation to ensure Single blind.
Interventions are randomized, and assess Effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on swallowing Ability without knowing the type of maneuvers received, ensuring that participants' expectations do not influence the results.
These procedures reduce the influence of prior expectations and ensure an effective study.
|
|
Other: Shaker Exercise
Shaker Exercise : Patients will be taught to lie in a recumbent position, look at their toes, and raise their head without lifting their shoulders toward their chest.
They maintain this posture for a minute before taking a brief break and repeating the head-raising motion.
For five days in a row, the exercise will performed twice a day in the morning and the afternoon.
Dysphagia exercises will be carried out five days a week for two weeks.
|
To achieve single blind in this trial, the participant is kept blinded to their group assignment (interventions and control groups) throughout the study.
The data collector administers the assigned intervention (Mendelsohn maneuver, effortful swallow training, and the Shaker exercise ) without revealing the participant's group assignment.
The researcher retains knowledge of group allocation to ensure Single blind.
Interventions are randomized, and assess Effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on swallowing Ability without knowing the type of maneuvers received, ensuring that participants' expectations do not influence the results.
These procedures reduce the influence of prior expectations and ensure an effective study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gugging swallowing screen
Time Frame: The data collection period 12 weeks
|
Gugging Screen: The instrument focuses on the swallowing screen (guss) developed by Michaela Trapl et al. 2007, S, which will be used to assess the severity of dysphagia in participants.
The English version will be used.Two component are involved in the GUSS that's are: part 1 (indirect swallow test) also called the preliminary assessment, and part 2 (the direct swallow test).
A point system was chosen, with a maximum of five points that can be scored in each subtest, where higher numbers indicate healthier performance.
To move on to the next subtest, you have to reach this maximum.
Every test item has a value of either one point (physiologic) or zero points (pathologic).
We employed a new rating inside the direct swallowing test's scoring criteria for "deglutition."
Pathologic swallowing receives 0 points, delayed swallowing receives 1 point, and normal deglutition receives 2 points.
To receive the maximum score of five points on the subtest.
|
The data collection period 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: shahlaa Ali, Baghdad University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
February 28, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
September 25, 2025
First Submitted That Met QC Criteria
December 6, 2025
First Posted (Estimated)
December 9, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
December 6, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Dysphagic Patients with CVA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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