Protocol summary

Study aim
Effect of compressed tongue range of motion exercises on dysphagia following cerebrovascular accident
Design
A randomized, blinded, sham controlled clinical trial with a parallel group design of 24 patients
Settings and conduct
24 patients will be divided into two control and experimental groups and Both groups will receive traditional dysphagia treatment for 6 weeks (3 sessions per week). The control group, they will receive the range of motion exercises of the tongue extracted from the traditional dysphagia treatment in the form of a set of 10 exercises in each session while, The experimental group receives the same exercises in each session in a set of 20 exercises (twice as much as the control group). Before starting treatment, after the end of the third week of treatment and after the end of six weeks of treatment, evaluation is done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. No history of any disease associated with dysphagia such as Parkinson's disease, cervical spinal cord injury, TBI, myasthenia gravis, and amyotrophic lateral sclerosis in the patient's medical history 2. The patient does not have cognitive disorders such as dementia 3. Suffering from dysphagia based on water test 4. Suffering from dysphagia in the oral and oral preparation phase 5. The patient has not yet undergone any treatment program to improve swallowing 6. The patient should be at least 20 years old 7. At least 3 months have passed since the stroke Exclusion criteria: 1. pregnancy 2. Dysphagia due to drug poisoning 3. Brain stem strokes 4. abandoning the treatment process by the patient 5. The patient's unwillingness to continue the treatment process
Intervention groups
Control group Experimental group
Main outcome variables
Subcategories of Mann assessment of swallowing ability that contains: Alertness; Cooperation; Auditory comprehension; Dyspraxia; Dysphasia; Dysarthria and etc

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231124060156N1
Registration date: 2023-12-08, 1402/09/17
Registration timing: registered_while_recruiting

Last update: 2023-12-08, 1402/09/17
Update count: 0
Registration date
2023-12-08, 1402/09/17
Registrant information
Name
Farshad Ghalandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1111 1111
Email address
farshadghl73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-26, 1402/09/05
Expected recruitment end date
2024-07-25, 1403/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Compressed Tongue Range of Motion Exercises on Dysphagia Following Cerebrovascular Accident
Public title
Effect of Compressed Tongue Range of Motion Exercises on Dysphagia Following Cerebrovascular Accident
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of any disease with dysphagia such as Parkinson, Cervical Spinal Cord injury, Traumatic brain injury, Myasthenia gravis and Amyotrophic Lateral Sclerosis Absence of cognitive disorders such as Dementia Dysphagia according to Water Test Dysphagia in oral and preparatory oral phase The patient does not undergone dysphagia treatment The patient must be at least twenty years old At least three month have passed since the stroke
Exclusion criteria:
pregnancy Dysphagia due to drug poisoning Brain stem strokes Abandoning the treatment process by the patient The patient's unwillingness to continue the treatment process
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization is used for this study. In this type of randomization, the number of 24 sample individuals based on the severity of the disease, they are placed in three classes (severe, moderate, mild). Then randomization in each floor by Swap block randomization method is done with block size 2. It is important to mention that the number of people in each floor must be pair numbers. Intervention and control groups called A or B It is assigned that this work is done by a person outside the research team and without the knowledge of the research team. Then randomization is done in each floor like this patient couple (2 patients) has been selected and Using a binary block previously prepared by a person outside the research team (the person doing the concealment) one is assigned to group A and the other to group B. This work continues until the end of patients on each floor. This process is done in all three floors
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researcher blinding
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Shahid Fakuri Boulevard, between Shahid Javan Square and Shahid Al Shahidi Square, Danesh Salamat Township, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٩١٩١ ٩١٧٧٨
Approval date
2023-08-18, 1402/05/27
Ethics committee reference number
IR.MUMS.REC.1402.171

Health conditions studied

1

Description of health condition studied
Dysphagia
ICD-10 code
R13.1
ICD-10 code description
Dysphagia

Primary outcomes

1

Description
1. Dysphagia score in the Mann Assessment of Swallowing Ability 2. Aspiration score in the Mann Assessment of Swallowing Ability test
Timepoint
Before the treatment. At the end of week 3 of treatment. At the end of week 6 of treatment. 6 weeks after the end of the treatment.
Method of measurement
The Mann Assessment of Swallowing Ability

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 12 patients with dysphagia due to stroke who will receive traditional dysphagia treatment exercises for a period of 6 weeks (3 sessions per week). This group will receive the range of motion exercises of the tongue extracted from the traditional treatment of dysphagia in each session as a set of 20 exercises (twice as much as the control group).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Doctor Gholam Ali Mamori
Street address
َAhmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research assistant of Mashhad University of Medical Sciences
Street address
Fakouri Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٩١٩١ ٩١٧٧٨
Phone
+98 51 3879 5031
Email
p.relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Ghaemi
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٩١٩١ ٩١٧٧٨
Phone
+98 51 3879 5031
Email
Ghaemih@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Ghaemi
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٩١٩١ ٩١٧٧٨
Phone
+98 51 3879 5031
Email
Ghaemih@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farshad Ghalandari
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No. 36, North Khayyam Ave., Bist Metri Zargaran., No 38 Pelak
City
Mashhad
Province
Razavi Khorasan
Postal code
9196717594
Phone
+98 51 1111 1111
Fax
Email
farshadghl73@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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