Protocol summary

Summary
The present study was designed to examine, effect of onset time of traditional swallowing therapy, on recovery of Dysphagia in stroke patients. Participants in this study are all stroke patients that are screened for swallowing problems by speech-language pathologist. Thirty patients showing signs of Dysphagia (Aspiration, oral & pharyngeal stage disorders) are included in this study, and then we do a videofluoroscopy for all patients. These patients on base of onset time of swallowing therapy are divided in three groups: One Immediately after stable medical state, second two weeks post Stroke, and 3rd group to begin at one month post stroke. These three groups have same range of age(40-70) and severity of swallowing disorders. The number of sessions and the duration of sessions should certainly be standardized across all patients (one hour therapy sessions three times a week for two months), after two month swallowing function in all of patients is examined clinical and videofluoroscopy again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072514161N1
Registration date: 2013-09-07, 1392/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-07, 1392/06/16
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
Tehran University of Medical Scirnces
Expected recruitment start date
2013-09-06, 1392/06/15
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of onset time of traditional swallowing therapy(TST) exercises on recovery from OroPharyngeal Dysphagia(OPD) in stroke patients
Public title
The effect of onset time of swallowing therapy exercises on recovery from Dysphagia in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : stroke , dysphagia,ability of auditory comprehension no Exclusion criteria:more than 70 years old, history of neurological disease affecting swallowing function and history of Chronic pneumonia, The next stroke during the study.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University Medical Sciences
Street address
Sixth Floor,Central bulding of Tehran University Medical Sciences,Ghods Ave,Keshvarz Blvd.
City
Tehran
Postal code
Approval date
2013-07-14, 1392/04/23
Ethics committee reference number
655/130/د/92

2

Ethics committee
Name of ethics committee
Tehran University Medical Sciences
Street address
The Sixth Floor,Cental Bulding of Tehran University Medical Sciences,Ghods Ave, Keshvarz Blvd
City
Tehran
Postal code
Approval date
2013-07-14, 1392/04/23
Ethics committee reference number
655/130/د/92

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
I67.9
ICD-10 code description
Cerebrovascular disease, unspecified

Primary outcomes

1

Description
improvement of Oropharyngeal Dysphagia
Timepoint
Two months after the start of intervention
Method of measurement
1-Northwestren dysphagia screening2-Oral Intake Scale3-videflouroscopy

2

Description
improvement of Oropharyngeal Dysphagia
Timepoint
2 month after intervention
Method of measurement
1-Northwestren dysphagia screening2-Oral Intake Scale3-videflouroscopy

Secondary outcomes

empty

Intervention groups

1

Description
In 3 groups of dysphagia patients swallowing rehabilitation includes:1-Head and neck posture changes(Chin tuck),..2-Swallowing muscles strength exercise 3-Sensory stimulation(Thermal Stimulation,Icing)4-Swallowing Maneuver for protecting the airway( supraglottic swallow, Mendelsohn Maneuver, Effortful Swallow) 5- Change Food consistencies. These exercises are done , Three times a week, in one hour therapy sessions for two months.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeni Hospital
Full name of responsible person
Dr.sarraf
Street address
Keshavarz Blvd - complex of Imam Khomeini Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr Attar- Bashi
Street address
Rehabilitation faculty-Enghelab avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehabilitation Faculty, 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
Rehabilitation Faculty, Tehran University Medical Sciences
Full name of responsible person
Jalal Bakhtiyari
Position
MS,c Speech Therapy, PhD Candidate of Speech Therapy
Other areas of specialty/work
Street address
Speech Therapy Department, Rehabilitation faculty, Tehran University Medical Sciences, Piche-Shemian, Enghelab Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 7753 5193
Fax
Email
jbakhtiyari@razi.tums.ac.irbakhtiyari.slp@gmail.combakhtiyarijalal@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Mohammad Hosseyn Harrirchian
Position
Neurologist-Professor
Other areas of specialty/work
Street address
Iranian Center of Neurological Center, Emam Khomeyni Hospital, Keshvaez Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8873 3731
Fax
Email
harirchm@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Speech Therapy Department, Rehabilitation Faculty, Tehran University Medical Sciences
Full name of responsible person
Jalal Bakhtiyari
Position
MS,c Speech Therapy, PhD Candidate of Speech Therapy
Other areas of specialty/work
Street address
Speech Therapy Department , Rehabilitation Faculty, Tehran University Medical Sciences, Piche Shemiran,Enghelab Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 7753 5132
Fax
+98 21 2226 9606
Email
jbakhtiyari@razi.tums.acbakhtiyari.slp@gmail.com
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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