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General information
2024-04-13, 1403/01/25
2024-12-21, 1403/10/01
2024-0412-1321 00:00:00
2024-11-04, 1403/08/14
2025-08-22, 1404/05/31
20242025-1108-0422 00:00:00
empty
refining the date of patients' recruitment
refining the date of patients' recruitment
empty
اصلاح تاریخ بیمارگیری
اصلاح تاریخ بیمارگیری
Recruitment centers
#1
Name of recruitment center - English: Speech therapy clinics, hospitals and health centers in Tehran
Name of recruitment center - Persian: کلینیکهای گفتاردرمانی، بیمارستانها و مراکز درمانی شهر تهران
Full name of responsible person - English: Speech therapist
Full name of responsible person - Persian: گفتاردرمانگر
Street address - English: Rehabilitation faculty, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St.
Street address - Persian: تهران، خيابان انقلاب، پيچ شميران، نبش خیابان صفی علیشاه، دانشکده توانبخشي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
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/
Name of recruitment center - English: Speech therapy clinic
Name of recruitment center - Persian: کلینیک گفتاردرمانی
Full name of responsible person - English: Maryam Alizadeh
Full name of responsible person - Persian: مریم علی زاده
Street address - English: Rehabilitation Faculty of Tehran University of Medical Sciences, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St., Tehran, Iran.
Street address - Persian: ایران، تهران، خيابان انقلاب، پيچ شميران، نبش خیابان صفی علیشاه، دانشکده توانبخشي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
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/
Name of recruitment center - English: Speech therapy clinics, hospitals and health centers in Tehranclinic Name of recruitment center - Persian: کلینیکهای گفتاردرمانی، بیمارستانها و مراکز درمانی شهر تهران Full name of responsible person - English: Speech therapistMaryam Alizadeh Full name of responsible person - Persian: گفتاردرمانگرمریم علی زاده Street address - English: Rehabilitation facultyFaculty of Tehran University of Medical Sciences, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St., Tehran, Iran. Street address - Persian: ایران، تهران، خيابان انقلاب، پيچ شميران، نبش خیابان صفی علیشاه، دانشکده توانبخشي City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) 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
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Azar Mehri
Full name of responsible person - Persian: دکتر آذر مهری
Street address - English: Rehabilitation faculty, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St.
Street address - Persian: خيابان انقلاب، پيچ شميران، نبش خیابان صفی علیشاه، دانشکده توانبخشي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
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/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Azar Mehri
Full name of responsible person - Persian: دکتر آذر مهری
Street address - English: Rehabilitation Faculty of Tehran University of Medical Sciences, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St., Tehran, Iran.
Street address - Persian: ایران، تهران، خيابان انقلاب، پيچ شميران، نبش خیابان صفی علیشاه، دانشکده توانبخشي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
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/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Azar Mehri Full name of responsible person - Persian: دکتر آذر مهری Street address - English: Rehabilitation facultyFaculty of Tehran University of Medical Sciences, Safi Alishah Ave., Pich-e-Shemiran, Enghelab St., Tehran, Iran. Street address - Persian: ایران، تهران، خيابان انقلاب، پيچ شميران، نبش خیابان صفی علیشاه، دانشکده توانبخشي City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) 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/
Protocol summary
Study aim
Investigating Dynamic Temporal and Tactile Cueing efficacy on speech in stroke patients with Apraxia of Speech
Design
Clinical trial without control group, without parallel-group, without blinding of researcher and participants, without randomization, phase 2 on 6 patients
Settings and conduct
The location for the study will be based on participant preferences. Dynamic Temporal and Tactile Cueing will then be implemented to improve the production of 10 trained words and phrases.
Participants/Inclusion and exclusion criteria
The study population comprises Persian literate and handwritten patients with AOS, of any gender, who have a history of stroke, normal Intelligence Quotient, and suitable auditory comprehension.
Intervention groups
Dynamic Temporal and Tactile Cueing will be implemented on all participants. This study doesn't have a control group.
Main outcome variables
Accuracy of trained and un-trained words and phrases; Percentage of Consonants Correct in trained and un-trained words and phrases; Percentage of Vowels Correct in trained and un-trained words and phrases
General information
Reason for update
refining the date of patients' recruitment
Acronym
IRCT registration information
IRCT registration number:IRCT20240224061099N1
Registration date:2024-05-04, 1403/02/15
Registration timing:prospective
Last update:2024-12-09, 1403/09/19
Update count:1
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
Maryam Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
alizadeh-m@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating Dynamic Temporal and Tactile Cueing efficacy on speech in stroke patients with Apraxia of Speech
Public title
Investigating Dynamic Temporal and Tactile Cueing (DTTC) efficacy on Apraxia of Speech (AOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of a stroke in the dominant hemisphere for the language that has been at least 6 months since its occurrence
Be monolingual Persian
Passing the Pure Tone Audiometry Screening test at the threshold of 35 dB at frequencies of 500, 1000, and 2000 for at least one ear; if the patient uses a hearing aid, it is necessary to confirm the hearing adequacy at the conversational level by an audiologist
Normal or corrected (using lenses or glasses) visual ability
Absence of alcohol or drug abuse, psychological and neurological disorders other than stroke based on self-report and confirmation by their medical records
Obtaining a normal range score of the non-verbal intelligence test using Raven's progressive matrices
Being right-handed by Edinburgh handedness questionnaire
Absence of dysarthria or mild dysarthria according to the Frenchay Dysarthria Assessment 2 (FDA-2)
Auditory comprehension above 50% in Persian Mississippi Aphasia Screening Test (MASTp) and Persian Diagnostic Aphasia Battery (P-DAB-1)
Has a literacy level of 8th grade and above
Diagnosis as AOS based on supplemental verbal apraxia test
Obtaining a minimum score of 32 (moderate severity) and above in the verbal apraxia test
Exclusion criteria:
History of more than a stroke in the dominant hemisphere for the language
6 months have not passed since the stroke
Not passing the Pure Tone Audiometry Screening test at the threshold of 35 dB at frequencies of 500, 1000, and 2000 for at least one ear
Failure to confirm hearing adequacy at the conversational level by an audiologist
Absence of normal vision or inability to correct defective vision using lenses or glasses
History of alcohol or drug abuse, psychological and neurological disorders other than stroke based on self-report and confirmation by medical records
Not obtaining a normal range score of the non-verbal intelligence test using Raven's progressive matrices
Not being right-handed, according to the Edinburgh Handedness Questionnaire
Having dysarthria above mild severity according to the Frenchay Dysarthria Assessment 2 (FDA-2) test
Not to be achieved auditory comprehension above 50% in the Persian Mississippi Aphasia Screening Test (MASTp) and the Persian Diagnostic Aphasia Battery (P-DAB-1)
Has a literacy level lower than 8th grade
Not diagnosing as AOS based on supplemental verbal apraxia test
Obtaining a score of lower than 32 in the verbal apraxia test
Age
From 5 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
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
2023-07-04, 1402/04/13
Ethics committee reference number
IR.TUMS.FNM.REC.1402.087
Health conditions studied
1
Description of health condition studied
Apraxia of Speech resulting from stroke
ICD-10 code
I69.390
ICD-10 code description
Apraxia following cerebral infarction
Primary outcomes
1
Description
Trained words and phrases accuracy
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
Percentage of accurate words and phrases
2
Description
Un-trained words and phrases accuracy
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
Percentage of accurate words and phrases
3
Description
Percentage of Consonants Correct in trained words and phrases
Timepoint
Continuous assessments in probe sessions in baseline, treatment, and following phases
Method of measurement
The number of consonants produced correctly in the trained words and phrases is divided by the total number of consonants and expressed as a percentage.
4
Description
Percentage of Consonants Correct (PCC) in un-trained words and phrases
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
The number of consonants produced correctly in the un-trained words and phrases is divided by the total number of consonants and expressed as a percentage.
5
Description
Percentage of Vowels Correct (PVC) in trained words and phrases
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
The number of vowels produced correctly in the trained words and phrases is divided by the total number of consonants and expressed as a percentage.
6
Description
Percentage of Vowels Correct (PVC) in un-trained words and phrases
Timepoint
Continuous assessments in probe sessions in baseline, treatment and following phases
Method of measurement
The number of vowels produced correctly in the un-trained words and phrases is divided by the total number of consonants and expressed as a percentage.
Secondary outcomes
1
Description
Type of aphasia
Timepoint
Before starting the baseline and after completing the treatment phase
Method of measurement
Based on comprehension and expression scores by The Persian version of the Mississippi Aphasia Screening Test (MASTp)
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
Apraxia of Speech severity
Timepoint
Before starting the baseline and after completing the treatment phase
Method of measurement
Based on verbal apraxia tasks for adults score
4
Description
Intelligibility in words and sentences
Timepoint
Before starting the baseline and after completing the treatment phase
Method of measurement
Based on speech intelligibility of Frenchay Dysarthria Assessment (FDA - 2)
5
Description
Percentage of Consonant Correct in producing words and spontaneous speech
Timepoint
Before starting the baseline and after completing the treatment phase
Method of measurement
Based on phonetic information test and spontaneous speech sample
Intervention groups
1
Description
Intervention group: Dynamic Temporal and Tactile Cueing (DTTC) method (24 sessions), 3 times a week, every session lasting 1 hour will be implemented. This treatment method involves a combination of integral stimulation, which includes "watch me," "listen carefully," and "repeat what I say," and intensive practice on a small set of vocabulary items such as words and short phrases. During this treatment, the clinician will use slow speech and tactile gestures as needed to clarify movement patterns, and the time between the clinician's model and the participant's repetition gradually increases to promote independent retrieval and planning of movement gestures. Knowledge of Performance feedback (KP) is used more frequently at first and then gradually decreases, transitioning to Knowledge of Results feedback (KR). Once the patient's skills have improved, KR feedback is eliminated to promote the patient's inner monitoring and control for maintaining production accuracy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Speech therapy clinic
Full name of responsible person
Maryam Alizadeh
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
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/
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
Maryam Alizadeh
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
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
alizadeh-m@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Alizadeh
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
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
alizadeh-m@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Alizadeh
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
Email
alizadeh-m@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
IPD
When the data will become available and for how long
The access period will commence six months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions