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Designing and determining the dosage of a treatment plan for swallowing disorder and comparing its effectiveness on swallowing function in patients following stroke in the Subacute phase

Designing and determining the dosage of a treatment plan for swallowing disorder and comparing its effectiveness on swallowing function in patients following stroke in the Subacute phase

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220311054258N2
Enrollment
45
Registered
2025-12-21
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing disorder following stroke in the acute phase. Dysphasia following cerebral infarction

Interventions

Intervention 1: Intervention group: The first group received resistance and tongue stretching exercises, high-pressure swallowing, and supraglottic swallowing maneuvers at 25% less than the dose recom

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: The patient age is between 20 and 80 years The patient has been diagnosed with ischemic stroke by a neurologist using CT or MRI and has no history of stroke in the past At least two weeks have passed since the stroke occurred According to the MASA test, the patient has oropharyngeal swallowing disorder The patient has not been concurrently undergoing any treatment program to improve the swallowing disorder No history of any other disease associated with swallowing disorder such as Parkinson's disease, cervical spinal cord injury, concussion, myasthenia gravis and amyotrophic lateral sclerosis, seizures, epilepsy, and multiple sclerosis No cognitive impairment, dementia, or Alzheimer's disease based on MOCA score = 27 NIHSS index score = 12

Exclusion criteria

Exclusion criteria: Severe reflux. Swallowing disorder due to drug toxicity. Severe restlessness and decreased consciousness. Having aphasia, severe speech and comprehension disorder (scoring a score of 4 or lower on the listening comprehension item of the Massa test and a score of 2 or lower on the aphasia item of the Massa test) Recurrence of stroke during treatment.

Design outcomes

Primary

MeasureTime frame
Change in total The Mann Assessment of Swallowing Ability score at 4 time points (before treatment, week 3, week 6, week 12, or follow-up phase). Timepoint: Before starting treatment, 21, 42 and 84 days after starting treatment. Method of measurement: The Mann Assessment of Swallowing Ability Test: This test consists of 24 items that assess three main areas (oral motor-functional swallowing mechanism-nutritional recommendations and determining the severity of risk in swallowing certain foods). This examination is a clinical assessment and requires few tools for the examination, and these tools include a flashlight, gloves, a suction tube, and some food in different concentrations and water. It is necessary for the examiner to have access to the patient's medical record. The scoring of the test is quantitative and the patient receives a score between 0 and 200. This test has a sensitivity of 73% and a specificity of 89%.

Secondary

MeasureTime frame
Median score of the penetration-aspiration scale with fiberoptic endoscopic evaluation of swallowing (FEES). Timepoint: Before the start of the intervention, 21, 42 and 84 days after the start of treatment. Method of measurement: A standard 8-point scale is used to grade the occurrence of aspiration or penetration based on the depth of food entry into the airway. A score of one means no food entry into the airway and a score of eight means aspiration without any attempt to expel the food, and is scored using images taken with a fiberoptic endoscopic evaluation of swallowing. In a clinical or research setting, when performing a FEZ test, a speech therapist or specialist will score the severity of the intrusion or aspiration based on the highest level seen during swallowing for each type of food or liquid, using video. This score is a numerical score from 1 to 8, with each number representing a specific condition, from "no intrusion" to "aspiration without effort to clear.".;Frequency of aspiration severity. Timepoint: Before the start of the intervention, 21, 42 and 84 days after the start of treatment. Method of measurement: The severity of food passing through the true vocal folds and entering the trachea, which can be with or without symptoms, is determined based on the total score of the Massa test. People with scores between 149 and 169 are classified as having mild aspiration. People with scores less than 148 are classified as having moderate aspiration, and people with scores less than or equal to 140 have aspiration disorders.;Severity of pharyngeal residue in the vallecula and pyriform sinuses with a 5-point scale protocol for assessing food residue in the vallecula and pyriform sinuses (Yale scale). Timepoint: Before the start of the intervention, 21, 42 and 84 days after the start of treatment. Method of measurement: In this study, the Yale Residue Protocol will be used as an operational scale for assessing food residue. During flexible endoscopic swallowi

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Mehdizadeh Behtash

Iran University of Medical Sciences

mahsamehdizadeh.slp@gmail.com021-2222059

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026