Neurogenic DysphagiaNCT07271888
Effect of Mendelsohn Maneuver, Effortful Swallow Training, and the Shaker Exercise on Swallowing Ability Among Dysphagic Patients With Cerebrovascular Accident
A study testing Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients. in people with Neurogenic Dysphagia, run by University of Baghdad.
Trial summary
The study aims to Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurogenic Dysphagia
- What is being tested?
- Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Shahlaa Ali Talib Street address Wasit, Street 571 City Wasit Ali SAli, Latest degree Master contact
About this study
Official title: 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.
Read the 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)
- Conditions
- Neurogenic Dysphagia
- Being tested
- Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Mendelsohn maneuver | Other | 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. Receives: Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients. |
| Effortful Swallow | Other | 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. Receives: Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients. |
| Shaker Exercise | Other | 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. Receives: Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gugging swallowing screen
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.
Measured: The data collection period 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic DysphagiaStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Research design: True-experimental research design will be used to investigate the effect of the swallowing exercises on improving the post stroke dysphagia. This study used to estimate the effect of an intervention on its target population with randomization . * The sample groups must be assigned randomly. * There must be a viable control group. * Only one variable can be manipulated and tested. * The tested subjects must be randomly assigned to either control or experimental groups.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahlaa Ali, University of Baghdad
- Investigators
- shahlaa Ali, Study director, Baghdad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271888
- Sponsor's protocol ID
- Dysphagic Patients with CVA
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mendelsohn Maneuver, Effortful Swallow Training, and the Shaker Exercise on Swallowing Ability Among Dysphagic Patients With Cerebrovascular Accident; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07271888
- Acronym / sponsor ID
- Dysphagic Patients with CVA
- Conditions
- Neurogenic Dysphagia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Research design: True-experimental research design will be used to investigate the effect of the swallowing exercises on improving the post stroke dysphagia. This study used to estimate the effect of an intervention on its target population with randomization . * The sample groups must be assigned randomly. * There must be a viable control group. * Only one variable can be manipulated and tested. * The tested subjects must be randomly assigned to either control or experimental groups.
| Arm | Type | Receives |
|---|---|---|
| Mendelsohn maneuver | Other | Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.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. |
| Effortful Swallow | Other | Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.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. |
| Shaker Exercise | Other | Other: Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, Mendelsohn maneuver, Shaker Exercise |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shahlaa Ali Talib Street address Wasit, Street 571 City Wasit Ali SAli, Latest degree Master contact
shahlaa Ali study director
Baghdad University
Questions about this trial
What is this clinical trial studying?
A study testing Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients. in people with Neurogenic Dysphagia, run by University of Baghdad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahlaa Ali Talib Street address Wasit, Street 571 City Wasit Ali SAli, Latest degree Master (+9647722809765, shahlaa.ali1202a@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gugging swallowing screen (time frame: The data collection period 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.