Protocol summary

Summary
The aim of this study is to investigate the efficacy of constraint - induced on naming deficit in acute aphasic patients. The goal of this study is to improve expressive & receptive language indexes. We use a single subject design with three acute aphasic individuals who receive 30 hours of constraint induced therapy over 28 days. Mississippi Screening Aphasia Test is collect during three phases: pre treatment( 3 weeks), during treatment(4 weeks), and follow up(3 weeks). In this study don't use drug. Inclusion criteria: Age 40 until 65 years old; stroke resulted in aphasia; Maximum 4 months after stroke; presence of naming deficit; right handed; normal or corrected vision and hearing ability; mono‑language (Persian); able to read and write. The exclusion criteria: History of drug abuse in the past 6 months; history of mental illnesses; history of psychotropic drug abuse; and recurrent stroke. Requiring time for this study is 12 month.

General information

Acronym
- Constraint Induced Aphasia Therapy - CIAT
IRCT registration information
IRCT registration number: IRCT2015112525194N2
Registration date: 2016-08-19, 1395/05/29
Registration timing: prospective

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
2016-09-08, 1395/06/18
Expected recruitment end date
2017-01-07, 1395/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Investigation of the Maintenance of Constraint- Induced Therapy on Expressive and Receptive Index in Acute Aphasic Patients.
Public title
The Effect Of Speech Therapy on Acquired Language Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 40 until 65 years old; stroke resulted in aphasia; Maximum 4 months after stroke; presence of naming deficit; right handed; normal or corrected vision and hearing ability; mono language (Persian); able to read and write. The exclusion criteria: History of drug abuse in the past 6 months; history of mental illnesses; history of psychotropic drug abuse; and recurrent stroke.
Age
From 39 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 3
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
2016-02-09, 1394/11/20
Ethics committee reference number
IRSEMUMS.REC.1394.181

Health conditions studied

1

Description of health condition studied
Aphasia Due To Cerebro Vascular Accident
ICD-10 code
I66.9, I66
ICD-10 code description
Occlusion and stenosis of unspecified cerebral artery, Occlusion and stenosis of middle cerebral artery

Primary outcomes

1

Description
Receptive & Expressive Index
Timepoint
3 Times BeFore Intervention, 4 Times During Intervention, 3 Times After Intervention
Method of measurement
Questionnaire, The Mississipi Aphasia Screening Test

Secondary outcomes

empty

Intervention groups

1

Description
Intensive Speech & Language Therapy For 4 Weeks, 3 Sessions Per Week, 150 Min Per Session
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 S
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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