Protocol summary

Summary
This study purpose is to explore a multi modal communication program for chronic aphasia patients.The multi modal communication program aims to improve communication modality production, and to facilitate switching among modalities to resolve communication breakdowns. Two patients with chronic aphasia participate multi modal communication program. During 3 weeks we delivered 9 hours treatment. outcome measures complete before(3 weeks), during (3 weeks) and after intervention(3 weeks): Modality production and switching accuracy are evaluation. In this study don't use drug. Inclusion criteria: Aphasia due to stroke; minimum 1 year after stroke; Health or corrected vision and hearing ability; right handed; between 40 until 65 years old. Exclusion criteria: history of drug abuse in 6 month past; psychotic drug abuse; recurrent stroke

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016032325194N3
Registration date: 2016-08-19, 1395/05/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-19, 1395/05/29
Registrant information
Name
Shohre Kaviani Tehrani
Name of organization / entity
Semnan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
kaviani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-08-05, 1395/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Investigation of the Multi Modal Therapy on Communication skills in chronic Aphasic Patients
Public title
The effects of speech therapy on speech and language disorder due to Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aphasia due to stroke; minimum 1 year after stroke; Health or corrected vision and hearing ability; right handed; between 40 until 65 years old Exclusion criteria: history of drug abuse in 6 month past; psychotic drug abuse; recurrent stroke
Age
From 39 years old to 64 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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 Science, Damghan Road, Semnan
City
Semnan
Postal code
3519899951
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
IRSEMUMS.REC.1395.54

Health conditions studied

1

Description of health condition studied
Aphasia due to Cerebro Vascular Accident
ICD-10 code
I660
ICD-10 code description
Occlusion and stenosis of middle cerebral artery

Primary outcomes

1

Description
Communication modality production and to switching among modalities
Timepoint
3 times before intervention, 3 times during intervention, 3 times after intervention
Method of measurement
Questionnaire, The Persian Aphasia Naming test

Secondary outcomes

empty

Intervention groups

1

Description
we use multi modal communication program for chronic aphasia patients. this intervention complete during 3 weeks, each week 3 session and 60 min per session. In this program we use gesture, writing, drawing, communication board and verbal output.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center, Rehabilitation Faculty Semnan University Of Medical
Full name of responsible person
Shohre Kaviani Tehrani
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University Of Medical Science
Full name of responsible person
Dr rashidi poor
Street address
Semnan University Of Medical Science, Damghan Road, Semnan
City
Semnan
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, Semnan University Of Medical Science
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
Neuromuscular Rehabilitation Research Center, Rehabilitation Faculty,Semnan University Of Medical Sc
Full name of responsible person
Shohre Kaviani Tehrani
Position
Master Of Speech & Language Pathologist
Other areas of specialty/work
Street address
Semnan University Of medical Science, Damghan road, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
Shohrekaviani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center, Rehabilitation Faculty, Semnan University Of Medical S
Full name of responsible person
Shohre Kaviani Tehrani
Position
Master Of Speech & Language Pathology
Other areas of specialty/work
Street address
Semnan University Of Medical Science, Damghan Road, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
Shohrekaviani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center, Rehabilitation faculty, Semnan university Of medical S
Full name of responsible person
Shohre Kaviani Tehrani
Position
Master Of Speech & Language Pathologist
Other areas of specialty/work
Street address
Semnan Uniersity Of Medical Science, Damghan Road, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
Shohrekaviani@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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