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The efficacy of Combining Inhibitory Control Treatment into an Errorless Naming Treatment upon word retrieval difficulties in patients with aphasia

Protocol summary

Summary
Objectives: The purpose of this study will be to evaluate the efficacy of Combining Inhibitory Control treatment into an Errorless Naming treatment upon word retrieval difficulties in patients with aphasia. Design: This study will be a randomized, double-blind clinical trial. Setting and conduct: Firstly, patients which referred by the neurologist to the speech language pathologist (SLP) will be evaluated via the screening and assessment tools. The patients who have the necessary criteria for inclusion, based on age and severity of aphasia would randomly divided into two groups : Intervention group (The Combining Inhibitory Control treatment) and control group (Errorless Naming treatment). Individual therapy would done for each person , in four consecutive weeks, three sessions per week and each session will last about 45 to 60 minutes. At the end of treatment, in order to compare the effectiveness of Errorless naming treatment and Combining Inhibitory Control treatment, all patients would assessed again by the SLP. Persian speaking patients which suffer from left hemisphere stroke (CVA), aged 20 to 65 years, with a minimum abilities of reading and writing and impaired language (aphasia) will be included. If subjects suffer from a new stroke during the treatment or if they won′t continue their cooperation, they will be excluded. Interventions: In this study, two interventions would done for control and interventon groups: Errorless Naming Treatment (Control group) and The Combining Inhibitory Control Treatment (Intervention group). Main outcome measures: In this study the main outcome measures will be: The ability to match Spoken word, picture; The ability to name picture; The ability to repeat word, non word; The ability of communicative effectiveness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042933682N1
Registration date: 2017-06-02, 1396/03/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-02, 1396/03/12
Registrant information
Name
Rezvan Akbari Manie
Name of organization / entity
Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7763 6042
Email address
r-akbarimani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Combining Inhibitory Control Treatment into an Errorless Naming Treatment upon word retrieval difficulties in patients with aphasia
Public title
Clinical trial comparing the efficacy of Errorless Naming Treatment and Combining Inhibitory Control Treatment upon word retrieval difficulties in patients with aphasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Proficiency in Persian language; Right-handedness; The range of age is 20 to 65 years; Having elementary literacy; Both genders; Cerebro Vascular Accident(CVA) is created in frontal or sub cortical structures in the left hemisphere; The dominant and sustainable language impairment along with Preservation of other mental functions(memory, attention, visual spatial deficits using Persian Aphasia diagnostic test (clinical version) and Mississippi test; Aphasia is not caused by factors such as trauma, metabolic disorders, and infection; Having no acute neurological or psychiatric problems; At least 6 months post-stroke; Having naming deficit (chief complain); Having auditory and visual acuity (with or without corrective device); Having no severe Apraxia; Having no severe Dysarthria. Exclusion criteria: If patient or his/her family would not continue the treatment and or; If patient during the treatment suffers from a new stroke or another neurological condition, he/she would be excluded.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
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
Tehran University of Medical Sciences
Street address
Enghelab street , Tehran University of Medical Sciences, Tehran
City
Tehran
Postal code
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2096

Health conditions studied

1

Description of health condition studied
aphasia
ICD-10 code
R47.0
ICD-10 code description
progressive isolated aphasia

Primary outcomes

1

Description
The ability to name pictures
Timepoint
Pre intervention, Post intervention, 1 month after intervention
Method of measurement
The score of Picture naming test

2

Description
The ability to match Spoken word, picture
Timepoint
Pre intervention, Post intervention, 1 month after interventioP
Method of measurement
The score of spoken word, picture matching test

3

Description
The ability to repeat word, non word
Timepoint
Pre intervention, Post intervention, 1 month after intervention
Method of measurement
The score of word, non word repetition test

4

Description
The ability of communicative effectiveness
Timepoint
Pre intervention, Post intervention, 1 month after intervention
Method of measurement
The score of the communicative effectiveness index

Secondary outcomes

1

Description
The ability of inhibitory control
Timepoint
Pre intervention, Post intervention, 1 month after intervention
Method of measurement
The score of Stroop test

Intervention groups

1

Description
Intervention group: The Combining Inhibitory Control Treatment. Treatment Duration: 4 successive weeks, 3 sessions per week, each session 45-60 minutes
Category
Treatment - Other

2

Description
Control group: Errorless Naming Treatment Treatment Duration: 4 successive weeks, 3 sessions per week, each session 45-60 minutes
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Farshchian Hospital
Full name of responsible person
Dr. Masoud Ghiasian
Street address
Mirzadeh Eshghi Street, Sina Farshchian Hospital, Hamedan, Iran.
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Enghelab Street, Tehran University of Medical Sciences, 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 of 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
Speech Therapy Department, School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Rezvan Akbari Manie
Position
PhD student of Speech Therapy
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Street, Tehran
City
Tehran
Postal code
Phone
+98 21776366042
Fax
Email
r-akbarimani@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Reza Khatoon Abadi
Position
PhD of Speech Therapy
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Street, Tehran
City
Tehran
Postal code
Phone
+98 21 7763 6042
Fax
+98 21 7763 6042
Email
khatoonabadi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rezvan Akbari Manie
Position
PhD student of Speech Therapy
Other areas of specialty/work
Street address
Piche Shemiran, Enghelab Street, Tehran
City
Tehran
Postal code
Phone
+98 21 7763 6042
Fax
+98 21 7763 6042
Email
r-akbarimani@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
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