Effect of Mendelsohn Maneuver, Effortful Swallow Training, and the Shaker Exercise on Swallowing Ability Among Dysphagic Patients With Cerebrovascular Accident

NCT ID: NCT07271888

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-03-01

Brief Summary

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)

Conditions

Neurogenic Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.

Intervention Type: 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.

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.

Group Type: OTHER

Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.

Intervention Type: 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.

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.

Group Type: OTHER

Compare the effect of Mendelsohn maneuver, effortful swallow training, and the Shaker exercise on neurogenic dysphagia among stroke patients.

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Shahlaa Ali

PhD student, Adult Nursing Department, Principal Investigator, nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shahlaa Ali

Role: STUDY_DIRECTOR

Baghdad University

Central Contacts

Shahlaa Ali Talib Street address Wasit, Street 571 City Wasit Ali SAli, Latest degree Master

Role: CONTACT

shahlaa.ali1202a@conursing.uobaghdad.edu.iq

+9647722809765

shahlaa Ali

Role: CONTACT

shahlaa.ali1202a@conursing.uobaghdad.edu.iq

+9647722809765

Other Identifiers

Dysphagic Patients with CVA

Identifier Type: -

Identifier Source: org_study_id