NCT07271888

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

September 25, 2025

Last Update Submit

December 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    The data collection period 12 weeks

Study Arms (3)

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.

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.

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.

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

Interventions

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 SwallowMendelsohn maneuverShaker Exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • shahlaa Ali

    Baghdad University

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, Adult Nursing Department, Principal Investigator, nurse

Study Record Dates

First Submitted

September 25, 2025

First Posted

December 9, 2025

Study Start

December 1, 2025

Primary Completion

February 28, 2026

Study Completion

March 1, 2026

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.