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The Effect of Traditional Dysphagia Therapy on The Swallowing function in patients with Multiple Sclerosis

Protocol summary

Summary
Dysphagia is one of the most common disorders associated with multiple sclerosis, which, if untreated, it can have a major impact on quality of life and dysphagia leads to weight loss, aspiration and lung infections.1- The purpose of this research is to study the effect of traditional dysphagia therapy on swallowing function for MS patients with dysphagia. 2- This study is a randomized double-blind clinical trial. 3- 20 patients with multiple sclerosis who Sinai Hospital Research Center, Tehran University of Medical Sciences were admitted with complaints of dysphagia, after considering the inclusion and exclusion criteria were enrolled in the study. Patients were randomly allocate into two groups. The principal researcher is therapist and will aware of types of treatment but she will blind to outcomes of assessment that done by assessor.On the other hand all patients and assessor blinded to types of treatment.It should be noted that patients were randomly allocated into two groups by the secretary of dysphagia clinic and so, therapist and assessor do not involve in allocating patients. 4- Inclusion criteria: Multiple Sclerosis patient; age ranges 20-60; Not receiving steroid drugs in the last month; Not having history of diseases associated with dysphagia; Not having history of cognitive disorders; dysphagia diagnosed by MASA test; Not having history of receiving any dysphagia therapy; Exclusion criteria: Having Severe reflux; Having dysphagia due to drug toxicity; Pregnancy; The patient's unwillingness to continue treatment. 5- Treatment:treatment protocol of the first group including compensatory postural changes, swallowing maneuvers, oral motor exercises and usual care. This treatment continued for 30 minutes, three days a week for 6 consecutive weeks will be provided. The second group (control group) will receive usual care, including changes in speed, volume and viscosity of food for 30 minutes, three days a week for 6 consecutive weeks will be provided. The presence and severity of dysphagia and aspiration assessments at baseline, at the end of the third week, the end of the sixth week and the end of the twelfth week (Follow up) is done in all groups. 6- Outcome measures: The score of MASA test and the score of aspiration-penetration scale

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022426721N2
Registration date: 2016-07-20, 1395/04/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-20, 1395/04/30
Registrant information
Name
Maryam Tarameshlu
Name of organization / entity
School of Rehabilitation,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7726 6778
Email address
tarameshlu@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Traditional Dysphagia Therapy on The Swallowing function in patients with Multiple Sclerosis
Public title
Dysphagia therapy in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria 1- Multiple Sclerosis patient; 2- age ranges 20-60; 3- Not having history of relapses and not receiving steroid drugs in the last month; 4- Not having history of stroke, Parkinson's disease, cervical spinal cord injury, traumatic brain injury, amyotrophic lateral sclerosis and myasthenia gravis; 5- Not having history of cognitive disorders such as Dementia; 4- dysphagia and aspiration diagnosed by MASA test; 6-Not having history of receiving any dysphagia therapy; Exclusion criteria: 1- Having Severe reflux; 2- Having Dysphagia due to drug toxicity; 3- Pregnancy; 4- The patient's unwillingness to continue treatment
Age
From 20 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth floor, Center building of University, Qods street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.TUMS.VCR.REC.1395.51

Health conditions studied

1

Description of health condition studied
Dysphagia
ICD-10 code
R13
ICD-10 code description
Difficulty in swallowing

Primary outcomes

1

Description
MASA Score
Timepoint
Beginning the first week, End of the third week, End of the sixth week, End of the twelfth week
Method of measurement
standard questionaire

Secondary outcomes

1

Description
Aspiration-Penetration Scale Score
Timepoint
Beginning the first week, End of the third week, End of the sixth week, End of the twelfth week
Method of measurement
Fiberoptic Endoscopic Evaluation of Swallowing

Intervention groups

1

Description
Intervention Group: The first group is provided traditional dysphagia therapy. It is included computational treatments , postural changes, oral-motor exercise, swallowing manures and usual cares. This treatment is provided for 30 min in 3 days of week and for 6 weeks.
Category
Rehabilitation

2

Description
Control Group : The second group is provided usual cares. This protocol included changes in speed, volume and viscosity of food. This treatment is provided for 30 min in 3 days of week and for 6 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Multiple Sclorosis Research Center, Sina Hospital
Full name of responsible person
Dr. Amir Reza Azimi
Street address
Sina Hospital, Hassan Abad Squ, Imam khomeini St, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Yunesian
Street address
Sixth floor, Center building of University, Qods street, Keshavarz Blvd ,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Rehabilitation
Full name of responsible person
Maryam Tarameshlu
Position
PhD candidate of Speech Therapy
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
m.tarameshlu@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Rehabilitation
Full name of responsible person
Maryam Tarameshlu
Position
PhD Candidate of Speech Therapy
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
tarameshlu@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Rehabilitation
Full name of responsible person
Maryam Tarameshlu
Position
PhD Candidate of Speech Therapy
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7753 3939
Fax
Email
tarameshlu@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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