Investigating the application-based treatment efficacy on the naming treatment in Persian-speaking patients with aphasia
Design
Clinical trial without control group, without parallel-group, without blinding of researcher and participants, without randomization, phase 3 on 3 patients
Settings and conduct
The location of the study will be determined based on the participant's preferences (speech therapy clinics); Implementation of application-based semantic feature analysis treatment to name 15 trained words on 3 patients with aphasia with naming disorder; Without blinding the researcher and participants
Participants/Inclusion and exclusion criteria
The study population comprises Persian-speaking patients 40 to 65 years old, with at least elementary literacy, with aphasia, of any gender, who have a history of stroke, without cognitive or neurological pathology, and suitable auditory comprehension.
Intervention groups
Application-based Treatment for naming will be implemented on all participants. This study doesn't have a control group.
Main outcome variables
- Trained words accuracy
- Untrained words accuracy
- Control words accuracy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240708062365N1
Registration date:2024-10-04, 1403/07/13
Registration timing:prospective
Last update:2024-10-04, 1403/07/13
Update count:0
Registration date
2024-10-04, 1403/07/13
Registrant information
Name
Shahla Fatemi-Syadar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
sh-fatemis@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An application-based treatment efficacy on the naming treatment in Persian-speaking patients with aphasia
Public title
An application-based treatment efficacy on the naming
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Between 40 and 65 years
Having basic literacy to read (part of the SFA treatment protocol requires reading skills if necessary).
Aphasia caused by the left hemisphere stroke (diagnosed by a neurologist based on CT scan imaging or MRI or medical reports).
At least 6 months have passed since the onset of aphasia due to stroke.
Have full command of the Persian language.
Major impairment in noun naming
Absence of cognitive impairment or mild cognitive impairment (Using the Aphasia Check List (ACL) Cognitive Test)
Absence of Apraxia (Based on the َApraxia test of adults) and dysarthria (Based on informal assesment of therapist)
Healthy or modified visual and hearing
َAuditory Comprehension ability is above 50%.
Have the ability to use the phone and follow orders.
There is a person's desire to participate in the study.
Exclusion criteria:
History of more than a stroke in the dominant hemisphere for the language
6 months have not passed since the stroke
History of alcohol or drug abuse, cognitive, psychological and neurological disorders other than stroke
Not diagnosing as Anomia based on Persian naming test
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
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
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Rehabilitation Faculty of Tehran University of Medical Sciences, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2023-12-16, 1402/09/25
Ethics committee reference number
IR.TUMS.FNM.REC.1402.178
Health conditions studied
1
Description of health condition studied
Aphasia and Anomia
ICD-10 code
R47.01
ICD-10 code description
Aphasia
Primary outcomes
1
Description
Trained words accuracy
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
The percentage of correctly named words
2
Description
Untrained words accuracy
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
The percentage of correctly named words
3
Description
Control words accuracy
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
The percentage of correctly named words
Secondary outcomes
1
Description
Quality of life of a patient with aphasia
Timepoint
Before starting the baseline and after completing the treatment phase
Method of measurement
based on the Persian version of the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
2
Description
Aphasia severity
Timepoint
Before starting the baseline and after completing the treatment phase
Method of measurement
Based on Persian Diagnostic Aphasia Battery (P-DAB-1) score
3
Description
Naming disorder severity
Timepoint
Before starting the baseline and after completing the treatment phase
Method of measurement
Based on the Persian picture naming test
Intervention groups
1
Description
Intervention group: designedtherapeuticapplication for naming disorder for 20 sessions (3 times per week), each session will be provided for one hour. This therapeutic application is based on thetratment approach of semantic features analysis (SFA), which is combined with intensive training on a small set of vocabulary items, which in this study is the target of treatment, the word. After selecting the treatment items, each word picture is presented to the subject in 6 steps. (Name the picture - listen to these semantic features and name the picture - what does the picture remind you of - whether these semantic features that I say are related to the picture or not - name the picture again - make a sentence with the desired picture .)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Speech therapy clinic
Full name of responsible person
Shahla Fatemi-Syadar
Street address
Rehabilitation Faculty of Tehran University of Medical Sciences, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St., Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Azar mehri
Street address
Enghelab St., Pich-e-Shemiran, Safi Alishah Ave., Rehabilitation Faculty of Tehran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahla Fatemi-Syadar
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Enghelab St., Pich-e-Shemiran, Safi Alishah Ave., Rehabilitation Faculty of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
sh-fatemis@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahla Fatemi-Syadar
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Enghelab St., Pich-e-Shemiran, Safi Alishah Ave., Rehabilitation Faculty of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
sh-fatemis@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shahla fatemi-syadar
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Enghelab St., Pich-e-Shemiran, Safi Alishah Ave., Rehabilitation Faculty of Tehran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
sh-fatemis@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individual patient information and evaluation and treatment results
When the data will become available and for how long