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IRCT20220311054258N2 IRCT 2025-12-21 Iran University of Medical Sciences 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 2026-01-21 anticipated 45 Recruiting https://irct.ir/trial/88101 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block (ratio 1:1:1), with allocation concealment through sealed opaque envelopes. Allocation implementation: An independent person generates the randomization list and prepares the envelopes; the therapist opens the envelope after the participant arrives and the subjects are assigned to the groups accordingly. This is a double-blind study and the blinding is as follows: Participants are not aware of the nature of the dose differences and their group; Visits are scheduled so that participants in different groups do not meet each other, Blinding description: This is a double-blind study and the blinding method is as follows: participants will not be aware of the nature of the dose differences and their group; visits will be scheduled in such a way that participants in different groups will not meet each other. N/A Swallowing disorder following stroke in the acute phase. 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 recommended in the literature, and received thermal-sensory stimulation at a fixed dose. Intervention 2: Intervention group: The second group received resistance and stretching exercises for the tongue, high-pressure swallowing, and supraglottic swallowing maneuvers at the doses recommended in the literature, and received thermal-sensory stimulation at a fixed dose. Intervention 3: Intervention group: The third group received resistance and tongue stretching exercises, high-pressure swallowing, and supraglottic swallowing maneuvers 25% more than the dose recommended in the literature, and received thermal-sensory stimulation at a fixed dose. Yes - There is a plan to make this available What will be shared: Releasable information about participants includes information related to primary and secondary outcomes and some non-identifiable medical information. When: Access will begin approximately 6 months after results are published. To whom: The data will be accessible to researchers working in academic and scientific institutions. Conditions: A decision will be made after data collection. Where to obtain: They can send a message to the relevant researcher's email and request mahsamehdizadeh.slp@gmail.com lghelichi@gmail.com How to obtain: If other researchers request access to the data, the information will only be provided after the request has been reviewed and approved by the researcher responsible for the project. The applicant will be required to provide a relevant research plan and a written undertaking to maintain the confidentiality of the data and use the information solely within the framework of scientific purposes. The data will be provided to the researchers in an anonymous and coded form, and no patient identification information will be provided. Comments:
public Mahsa Mehdizadeh Behtash
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madakaran Street, Shah Nazari Street, Madar Square, Mirdamad, Tehran
Tehran Iran (Islamic Republic of) 1348715459 021-2222059 mahsamehdizadeh.slp@gmail.com Iran University of Medical Sciences scientific Dr. Leila Ghelichi
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Madadkaran Street, Shah Nazari Street, Madar Square, Mirdamad, Tehran
Tehran Iran (Islamic Republic of) ۱۳۴۸۷ ۱۵۴۵۹ +98 21 2222 2059 lghelichi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 20 years 80 years Both 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. I69.321 Dysphasia following cerebral infarction Rehabilitation Rehabilitation Rehabilitation Intervention group: The first group received resistance and tongue stretching exercises, high-pressure swallowing, and supraglottic swallowing maneuvers at 25% less than the dose recommended in the literature, and received thermal-sensory stimulation at a fixed dose. Intervention group: The second group received resistance and stretching exercises for the tongue, high-pressure swallowing, and supraglottic swallowing maneuvers at the doses recommended in the literature, and received thermal-sensory stimulation at a fixed dose. Intervention group: The third group received resistance and tongue stretching exercises, high-pressure swallowing, and supraglottic swallowing maneuvers 25% more than the dose recommended in the literature, and received thermal-sensory stimulation at a fixed dose. 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%. 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 swallowing assessment, the remaining food morsel after swallowing in the two areas of the volvulus and piriform sinuses will be examined by a trained researcher and scored based on the 5-point Yale scale. Severity of swallowing disorder. Timepoint: Before the start of the intervention, 21, 42 and 84 days after the start of treatment. Method of measurement: The severity of the inability to swallow liquids and foods is calculated as a rank based on the total score of the MASA test. Based on the cut-off score of the test, people with scores between 168 and 177 are classified as having mild dysphagia. People with scores between 139 and 167 are classified as having moderate dysphagia, and people with a score of less than or equal to 138 have severe dysphagia. Iran University of Medical Sciences Approved 2025-12-14 ethics committee of Iran university of medical sciences Vice President for Research and Technology, central Headquarters Building, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)