Protocol summary

Study aim
The effect of tele-traditional dysphagia therapy in comparison with tele-usual care on swallowing function in MS
Design
The present study was a one-way blind clinical trial in which a SLP screened for dysphagia in patients with MS using the Dimas ten-item questionnaire. Following the completion of the assessment process, patients are randomly divided into two groups: control (tele-usual care) and experimental (tele-traditional treatment).
Settings and conduct
The SLP of the Eligible patients selected from Sina Hospital and screened dysphagia in patients with MS using the Dimas ten-item questionnaire. If a patient with dysphagia is identified, in order to accurately assess swallowing function and quality of life associated with swallowing, the MASA clinical test (Appendix 3) and the SWAL-QOL questionnaire (Appendix 4) are performed, respectively, and patients are randomly divided into two control and experimental groups.
Participants/Inclusion and exclusion criteria
1. Diagnosis of MS 2. No history of cognitive impairment 3- Confirmation of patient's swallowing disorder based on Dimas questionnaire 4- Age range 60-20 years 5- No recurrence of the disease in a recent month 6- No vision and hearing problems 7- Suitable motor independence for sitting 8. Patients' access to the Internet and telecommunication services (computer / mobile system) Exclusion criteria 1- Deficiency in completing the questionnaire of disease recurrence and occurrence of MS attacks during the treatment period 2. The patient's unwillingness to continue 3. The patient dies 4- Lack of regular participation of the person in sessions
Intervention groups
The control received only tele-usual care and the experimental received both tele-traditional dysphagia treatment and tele-usual care.
Main outcome variables
Determining the effectiveness of tele-traditional dysphagia treatment on swallowing function in dysphagic in MS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210529051428N1
Registration date: 2022-02-01, 1400/11/12
Registration timing: registered_while_recruiting

Last update: 2022-02-01, 1400/11/12
Update count: 0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Mehrdad Khalili Badamyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3454 9460
Email address
mehrdadkhalili110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-03-10, 1400/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tele-traditional dysphagia therapy in comparison with tele-usual care on swallowing function in patients with multiple sclerosis
Public title
tele- dysphagia treatments in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS No history of cognitive impairment Confirmation of patient's swallowing disorder based on Dimas questionnaire Age range 20-60 years No recurrence of the disease in a recent month No vision and hearing problems Independent movement independence for sitting Patients' access to the Internet and telecommunication services (computer / mobile system). Exclusion criteria: Deficiency in completing the questionnaire of disease recurrence and occurrence of MS attacks during the treatment period The patient's unwillingness to continue treatment The patient dies Lack of regular and continuous participation of the person in treatment sessions
Exclusion criteria:
Recurrence of the disease and occurrence of MS attacks during the treatment period The patient's unwillingness to continue treatment Death of the patient Lack of regular and continuous participation of the person in treatment sessions
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data and Safety Monitoring Board
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
All MS patients referred to the MS Clinic and MS Research Center of Sina Hospital will be examined. Patients with admission requirements will be included in the study and will be available by control sampling method and block randomization in each of the control groups (usual care) and experimental (usual care and traditional dysphagia therapy). For this purpose, an envelope containing the names of the treatment groups (usual care / traditional dysphagia therapy) will be provided to the clinic secretary. The secretary randomly removes a sheet from the envelope and hands it to the patient. The patient will submit a sheet containing the name of their treatment group to the therapist.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients with MS will not be aware of the treatment used. However, the evaluator (speech and language pathologist) or the therapist will know about the treatment groups because the evaluations will be done after the separation of the type.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran Iran University of Medical Sciences,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.IUMS.REC.1400.036

Health conditions studied

1

Description of health condition studied
The effect of tele-traditional dysphagia therapy in comparison with tele-usual care on swallowing function in patients with multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Swallowing performance score in MASA questionnaire
Timepoint
During 18 sessions of patients evaluation and treatment
Method of measurement
MASA questionnaire

Secondary outcomes

1

Description
Quality of life score
Timepoint
During 18 sessions of patients evaluation and treatment
Method of measurement
SWAL-QOL questionnaire

Intervention groups

1

Description
Intervention group: The first group (experimental group) receives traditional dysphagia treatment in addition to usual care therapy.
Category
Rehabilitation

2

Description
Control group: The second group (control group) receives only usual care therapy.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Special Center of Patients Association
Full name of responsible person
Mehrdad Khalili Badamyar
Street address
Shahid Hemmat Highway, between Sheikh Fazl A. Nouri and Shahid Chamran, Iran University of Medical Sciences Iran University of Medical Sciences, Tehran,Iran,
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 910 990 4886
Email
mehrdadkhalili110@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran Iran University of Medical Sciences,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2212
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Khalili Badamyar
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran Iran University of Medical Sciences,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 4416 7405
Email
mehrdadkhalili110@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila ghelichi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran Iran University of Medical Sciences,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
009844167405
Email
Lghelichi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Khalili Badamyar
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Shahid Hemmat Highway between Sheikh Fazl ... Nouri and Shahid Chamran Iran University of Medical Sciences,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 4416 7405
Email
mehrdadkhalili110@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
Not applicable
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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