1. Evaluation of the effect of pyridostigmine on MASA score improvement and PSR time in patients with stroke-induced swallowing disorder
3. The relationship between age, gender and location of stroke lesion with the effect of pyridostigmine in the recovery of stroke-induced swallowing disorder
Applied:
1. Early diagnosis of swallowing disorder in stroke patients using appropriate clinical methods
2. Improving stroke prognosis by preventing complications of dysphagia and aspiration
3.Reduce public health costs by reducing stroke complications
Design
Two arm parallel groups randomized double-blind pilot trial (each group:12 patients)and randomized groups based on blocking
Settings and conduct
Sampling: Firoozgar hospital Neurology department and ICU.
Patients and also speech therapists who perform basic and fallow up assessments of patients are not aware of belonging to the intervention or control group. Data analysis will be done blinded and based on data encoding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ischemic stroke diagnosed based on CT scan or MRI, which are based on MASA score (score>177) and PSR reflex time (time>than 1.5 s), have stroke-related dysphagia within 14 to 180 days of their stroke. (Due to the high probability of spontaneous swallowing recovery in stroke patients in the first two weeks, patients have not entered in the first 14 days). Examination: by the speech therapist at the beginning of the study and follow-up
Exclusion criteria: Age<18 years, hemorrhagic stroke, head and/or neck trauma
Intervention groups
Intervention group: The group who receive pyridostigmine tablets three times a day for one month.
Control group: The group receiving placebo tablets with similar amounts.
Both intervention and control groups will benefit from speech therapy similarly during this period.
Main outcome variables
MASA score; PSR time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050383N1
Registration date:2021-02-21, 1399/12/03
Registration timing:registered_while_recruiting
Last update:2021-02-21, 1399/12/03
Update count:0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Seyedeh Enssieh Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 3192
Email address
enssieh.hashemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-18, 1399/11/30
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of pyridostigmine in post-stroke dysphagia
Public title
Effect of pyridostigmine in post-stroke dysphagia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ischemic stroke revealed by CT scan or MRI 14 to 180 days before intervention
and diagnosed to have post-stroke dysphagia according to MASA score(more than 177) and PSR time(more than 1.5 s) assessed by a speech pathologist.
Exclusion criteria:
Younger than 18
Hemorrhagic stroke
Stroke onset before 14 days or after 180 days
Head and/or neck injuries
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
We use block size 4 randomization with equal probability for eligible patients to enter groups A and B.
According to Block Size 4, we have six possible combinations for assigning individuals to groups, including AABB, ABAB, BAAB, BABA, BBAA and ABBA.
At the beginning of the study, we randomly select one of these arrangements and four eligible patients are placed on each block, respectively. We repeat this process several times until all eligible patients are examined.
Randomization Tool: Random Numbers Table
Randomization is concealed in an sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who participate in the project based on informed consent do not know their belonging to the intervention or control group. Due to the nature of the intervention and the design method of the study, only the specialist physician in the course of the treatment is aware of the intervention. Other physicians and speech pathologist who perform examinations of the patients at the beginning and in subsequent referrals will be unaware of the patient's belonging to the intervention or control group. Also, the statistician does not know the identity of the patients and the researcher who collects the patients' information only collects the information through a numerical list in which the patients' names are not available.
Placebo
Used
Assignment
Parallel
Other design features
This study is currently a pilot study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Iran University of Medical Sciences
Grade of patients dysphagia according to Mann Assessment of Swallowing Ability score sheet
Timepoint
Measuring the score of Mann Assessment of Swallowing Ability questionnaire in patients at the beginning of the study (before the intervention) and 30 days after the use of pyridostigmine
Method of measurement
Mann Assessment of Swallowing Ability questionnaire
2
Description
Pharyngeal swallowing Reflex time
Timepoint
Measurement of pharyngeal swallowing reflex time in patients at the beginning of the study (before the intervention) and 30 days after the use of pyridostigmine
Method of measurement
Assessed by Speech pathologist bedside
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Tablet Pyridostigmine 60 mg TDS before each meals for one month
Category
Treatment - Drugs
2
Description
Control group: a Placebo tablet one before each meal (three times a day) for one month
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Unidentifiable data of individuals and related dictionaries are prepared as checklists that can be provided to other researchers after the study is finished and the results are published. Additional documents such as study protocol, data analysis program, etc. will also be shared. Also, the informed consent form and clinical study report can be shared.
When the data will become available and for how long
Starting access period after publishing the study results
To whom data/document is available
After publishing the results of the study, the data and other documents of the study are for researchers, including employed in academic and scientific institutions and people who are engaged in the industry, will be accessible.
Under which criteria data/document could be used
Due to the lack of the patients' personal data, the use of documentation and analysis on it is permitted.
From where data/document is obtainable
Applicants can send a message to the trial plan's executor via email enssieh.hashemi@gmail.com or communicate with the executor via correspondence with the postal address of the sampling location.
What processes are involved for a request to access data/document
The requester of these documents or data files will list their request by email and the request will be processed as soon as possible.