The comparison of effectiveness of regular and irregular past tense treatment on sentence production and neural function in patients with agrammatic aphasia
1. Developing tests and tasks for the assessment of regular and irregular verb tense inflection in patients with agrammatic aphasia; 2. Developing a task for the assessment of sentence production; 3. Presenting a Persian verb tense inflection treatment for improving sentence production in patients with agrammatic aphasia.
Design
Applied-fundamental study with single subject experimental design (SSED)
Settings and conduct
After receiving the code of ethics committee from the Tehran University of Medical Sciences, the assessment and treatment tasks will be developed and standardized. Then according to inclusion and exclusion criteria the patients will be selected, assessed and treated. This study will perform in the faculty of rehabilitation at Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
1. Patient symptoms of non-fluent aphasia and aphasia quotient (AQ) between 51 to 75 on the test P-DAB-1 that represents the moderate aphasia; 2. difficulty in the verb tense inflection with less than 50 % in accuracy of regular and irregular verb tense inflection; 3. Patients who are Persian monolingual or are fluent in Persian if they are bilingual.
Intervention groups
The procedure of the ACTION treatment plan is first translated and prepared in Persian. Then, using the program instructions, the patients are treated. Each treatment session begins with the use of therapeutic probs that practices 10 sentences with training verbs in the past tense. Images designed for verbs will be used in the past tense. Assessment of therapeutic and generalization probes is performed every 3 sessions and includes 20 irregular verbs and 20 irregular verbs of the past tense.
Main outcome variables
Trained and generalization verb tense inflection score; trained and generalization sentence production score; the place of the activated brain area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191112045415N1
Registration date:2019-12-08, 1398/09/17
Registration timing:prospective
Last update:2019-12-08, 1398/09/17
Update count:0
Registration date
2019-12-08, 1398/09/17
Registrant information
Name
vahid valinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 2442 3269
Email address
valinejad.vahid@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of regular and irregular past tense treatment on sentence production and neural function in patients with agrammatic aphasia
Public title
Effect of verb treatment on sentence production in aggrammatism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient symptoms of non-fluent aphasia and aphasia quotient (AQ) between 51 to 75 on the test P-DAB-1 that represents the moderate aphasia
Earn more than 50% on the subscales of Auditory Comprehension and Continuous Instructions on the P-DAB-1 test
Agrammatic sentence production according to descriptive speech (Bird's Nest) and story retelling (three kids) in a way that speech is distorted and non-fluent; the percentage of sentences is reduced, and production of grammatical morphemes and verbs is reduced
Difficulty in the verb tense inflection with less than 50 % in accuracy of regular and irregular verb tense inflection
The ability to read in the subtest of single word reading in Bilingual Aphasia Test (BAT)
Right-handed patient (using Edinburgh scale)
Patients who are Persian monolingual or are fluent in Persian if they are bilingual
Normal or near normal visual ability
Normal or near normal hearing
Minimum 9th grade education
The patient has a stroke lesion on the left side of the brain, which last at least six months of its occurrence
Aged between 18 - 65 years old
Exclusion criteria:
History of neurological and psychological problems, speech and language problems, and learning problems
Patients with apraxia
Patients with Dysarthria in informal assessment
Sign of claustrophobia
Pregnant female subjects
Subjects who have metal prosthesis
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
6
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 Tehran University of Medical Science
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14179-33791
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.TUMS.FNM.REC.1398.145
Health conditions studied
1
Description of health condition studied
aphasia
ICD-10 code
R47.01
ICD-10 code description
Aphasia
Primary outcomes
1
Description
trained and generalization verb tense inflection score
Timepoint
verb tense inflection assessment for 17 times: 3 baselines, 12 during treatment (once per week for 12 weeks), 14 and 30 days after treatment
Method of measurement
verb tense inflection assessment test
2
Description
trained and generalization sentence production score
Timepoint
sentence production assessment for 17 times: 3 baselines, 12 during treatment (once per week for 12 weeks), 14 and 30 days after treatment
Method of measurement
sentence production test
3
Description
the place of the activated brain area
Timepoint
brain activation imaging 2 times: once pre-treatment and once after treatment
Method of measurement
functional magnetic resonance imaging
Secondary outcomes
1
Description
sentence production score
Timepoint
sentence production assessment for 17 times: 3 baselines, 12 during treatment (once per week for 12 weeks), 14 and 30 days after treatment
Method of measurement
sentence production assessment test
Intervention groups
1
Description
Intervention group: ACTION treatment will be performed on patients with agrammatic aphasia with a focus on verb learning and its tense inflection in sentence structure. The treatment steps are as follows: Stage 1 Syntactic Level: Recovery of nonverbal verbs in sentence context. a picture is shown with a sentence under it, in which the verb, in infinitival form, is left out.The participant reads the sentence (if necessary with the help of the therapist) and has to fill in the missing verb orally. Step 2: Syntactic-syntactic step: Retrieves the verb in the context of the sentence. As in step 1, but here the verb tense has to be inflected correctly . a picture is shown with a sentence under it, in which the verb, in infinitival form, is left out.The participant reads the sentence (if necessary with the help of the therapist) and has to fill in the missing verb orally. Step 3. Sentence construction: An image is shown to the participant and he or she must make a grammatical sentence.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Tehran University of Medical science
Full name of responsible person
Vahid Valinejad
Street address
School of Rehabilitation, Tehran University of Medical Sciences, Pich-e-Shemiran, Enghelab Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
14179-33791
Phone
+98 21 7753 4364
Email
valinejad.vahid@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azar Mehri
Street address
School of Rehabilitation, Tehran University of Medical Sciences, Pich-e-Shemiran, Enghelab Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
11489-56111
Phone
+98 21 7753 3939
Email
mehri@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?