Protocol summary

Study aim
Effects of oromotor exercises on recovery clinical swallowing function in elderly
Design
Randomization was undertakenThe elderly using a block randomization technique are allocated into one of two groups: experimental group that receive oromotor exercises and control group that receive compensatory exercises for dysphagia.
Settings and conduct
All elderly peoples are screened by the North-western Dysphagia Patient Check Sheet, and dysphagia was diagnosed by a speech pathologist. In all patients after primary diagnosis of dysphagia, swallowing functions were assessed by Mann Assessment of Swallowing Ability (MASA) , and Dysphagia Handicap Index (DHI). These peoples were allocated into two groups of 10 people: exprimental group: that receive oromotor exercises and control group that receive compensatory exercises for dysphagia. For all patients, includes compensatory methods and oromotor exercises are given by the speech pathologist 5 times per week for1 month.
Participants/Inclusion and exclusion criteria
1)Age range of 60-85 2) Clinical diagnosis of Oropharyngeal Dysphagia 3)No history of pneumonia or head and neck surgery and other neurological or general disorders that can influence swallowing function.
Intervention groups
Elderly people are randomized into two groups:experimental group that receive oromotor oromotor exercises include: Tongue-strengthening exercise,Masako Maneuver,Shaker exercises,Expiratory muscle strength training (EMST) and Lip-strengthening exercise) and control group that receive compensatory exercises for dysphagia.
Main outcome variables
Outcome measures in this study included: 1-Scores of the Persian-North-Western dysphagia patient check sheet 2-Scores of the Mann Assessment of Swallowing Ability (MASA) 3--Scores of the Dysphagia Handicap Index (DHI)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130725014161N2
Registration date: 2019-03-09, 1397/12/18
Registration timing: prospective

Last update: 2019-03-09, 1397/12/18
Update count: 0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Jalal Bakhtiyari
Name of organization / entity
Tehran University of Medica Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
jbakhtiyari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
2019-03-19, 1397/12/28
Scientific title
Effects of oromotor exercises on recovery clinical swallowing function in elderly
Public title
Effects of oromotor exercises on recovery clinical swallowing function in elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 60-85 No history of neurological or general disorders that can influence swallowing function and no history of pneumonia or head and neck surgery and Radio therapy No history of tobacco abuse Clinical diagnosis of oro-Pharyngeal Dysphagia At least has literacy to read and write
Exclusion criteria:
The occurrence of any illness and the problem that affects the function of ingestion is the departure of the individual from the study. Failure to cooperate during the study The Occurrence of any illness or problem that affects the function of swallowing
Age
From 60 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is undertaken using a block randomization technique.
Blinding (investigator's opinion)
Single blinded
Blinding description
Elderly people with Oropharyngeal Dysphagia(OPD)are allocated into one of two groups according to type of intervention of swallowing therapy including:1)oromotor exercises and2)Usual care and Compensatory techniques, none of whom were informed about their groups.In this study the researchers are aware of the groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences (SEMUMS), Central Headquarter of University, Bassij Blvd., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799422
Approval date
2018-08-21, 1397/05/30
Ethics committee reference number
IR.SEMUMS.REC.1397.139

Health conditions studied

1

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

Primary outcomes

1

Description
Clinical Swallowing Function
Timepoint
One Month after primary assessment
Method of measurement
1-Scores of the Persian- North-Western dysphagia patient check sheet2-Scores of the Mann Assessment of Swallowing Ability (MASA)3--Scores of the Persian -Dysphagia Handicap Index (DHI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: oromotor exercises(Muscle Strengthening exercises)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabatabaee Comprehensive Rehabilitation Center
Full name of responsible person
Elham Fatemi
Street address
Tabatabaee Comprehensive Rehabilitation Center,Qods St,Semnan Province, Semnan, IranQods St
City
Semnan
Province
Semnan
Postal code
3514799422
Phone
+98 23 3332 8502
Email
nmrrs@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Semnan University of Medical Sciences (SEMUMS), Central Headquarter of University, Bassij Blvd., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799422
Phone
+98 23 3344 1021
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr.Jalal Bakhtiyari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Semnan University of Medical Sciences (SEMUMS), , Standard Sq., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799422
Phone
+98 23 3365 4180
Email
bakhtiyari.slp@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Jalal Bakhtiyari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Semnan University of Medical Sciences (SEMUMS),Standard Sq., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799422
Phone
+98 23 3365 4180
Email
bakhtiyari.slp@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Jalal Bakhtiyari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Semnan University of Medical Sciences (SEMUMS), Standard Sq., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799422
Phone
+98 23 3365 4180
Email
bakhtiyari.slp@gmail.com

Sharing plan

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
All participant data will be shared after the encoding including age, sex, severity of dysphagia, test results, and research implementation method.
When the data will become available and for how long
Six months after the publication, the results will be shared.
To whom data/document is available
All researchers, including members of the faculty of universities and students.
Under which criteria data/document could be used
For use in meta-analysis studies or citation data in other relevant studies.
From where data/document is obtainable
Academic Officer; Dr. Jalal Bakhtiyari Email:bakhtiyari.slp@gmail.com Mobile:00989123717072
What processes are involved for a request to access data/document
Immediately after the call, the information will be sent.
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