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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. An adult patient diagnosed with stroke.
  2. Patients who had been diagnosed with dysphagia after stroke.
  3. 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:

  1. Unstable angina and myocardial infarction)MI(.
  2. History of seizure.
  3. Head injury or neurological disease other than stroke, neurosurgery .
  4. Oral and maxillofacial surgery.
  5. Dysphagia prior to stroke.
  6. Gastrointestinal tract upsets.
  7. Patients who receive hypnotics or sedation.
  8. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.
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.
Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.
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.
Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Baghdad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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