Protocol summary
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Study aim
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Investigating Dynamic Temporal and Tactile Cueing efficacy on speech in stroke patients with Apraxia of Speech
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Design
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Clinical trial without control group, without parallel-group, without blinding of researcher and participants, without randomization, phase 2 on 6 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Dynamic Temporal and Tactile Cueing will be implemented on all participants. This study doesn't have a control group.
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Main outcome variables
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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
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Reason for update
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refining the date of patients' recruitment
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Acronym
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IRCT registration information
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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
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Registration date
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2024-05-04, 1403/02/15
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-12-21, 1403/10/01
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Expected recruitment end date
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2025-08-22, 1404/05/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating Dynamic Temporal and Tactile Cueing efficacy on speech in stroke patients with Apraxia of Speech
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Public title
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Investigating Dynamic Temporal and Tactile Cueing (DTTC) efficacy on Apraxia of Speech (AOS)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 5 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
6
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-07-04, 1402/04/13
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Ethics committee reference number
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IR.TUMS.FNM.REC.1402.087
Health conditions studied
1
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Description of health condition studied
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Apraxia of Speech resulting from stroke
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ICD-10 code
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I69.390
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ICD-10 code description
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Apraxia following cerebral infarction
Primary outcomes
1
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Description
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Trained words and phrases accuracy
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Timepoint
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Continuous assessments in probe sessions in baseline, treatment and following phases
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Method of measurement
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Percentage of accurate words and phrases
2
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Description
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Un-trained words and phrases accuracy
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Timepoint
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Continuous assessments in probe sessions in baseline, treatment and following phases
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Method of measurement
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Percentage of accurate words and phrases
3
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Description
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Percentage of Consonants Correct in trained words and phrases
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Timepoint
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Continuous assessments in probe sessions in baseline, treatment, and following phases
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Method of measurement
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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
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Description
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Percentage of Consonants Correct (PCC) in un-trained words and phrases
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Timepoint
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Continuous assessments in probe sessions in baseline, treatment and following phases
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Method of measurement
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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
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Description
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Percentage of Vowels Correct (PVC) in trained words and phrases
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Timepoint
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Continuous assessments in probe sessions in baseline, treatment and following phases
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Method of measurement
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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
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Description
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Percentage of Vowels Correct (PVC) in un-trained words and phrases
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Timepoint
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Continuous assessments in probe sessions in baseline, treatment and following phases
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Method of measurement
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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
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Description
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Type of aphasia
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Timepoint
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Before starting the baseline and after completing the treatment phase
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Method of measurement
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Based on comprehension and expression scores by The Persian version of the Mississippi Aphasia Screening Test (MASTp)
2
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Description
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Aphasia severity
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Timepoint
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Before starting the baseline and after completing the treatment phase
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Method of measurement
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Based on Persian Diagnostic Aphasia Battery (P-DAB-1) score
3
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Description
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Apraxia of Speech severity
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Timepoint
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Before starting the baseline and after completing the treatment phase
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Method of measurement
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Based on verbal apraxia tasks for adults score
4
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Description
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Intelligibility in words and sentences
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Timepoint
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Before starting the baseline and after completing the treatment phase
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Method of measurement
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Based on speech intelligibility of Frenchay Dysarthria Assessment (FDA - 2)
5
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Description
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Percentage of Consonant Correct in producing words and spontaneous speech
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Timepoint
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Before starting the baseline and after completing the treatment phase
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Method of measurement
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Based on phonetic information test and spontaneous speech sample
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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IPD
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When the data will become available and for how long
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The access period will commence six months after the results are published.
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Based on the dissertation supervisor's opinion
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From where data/document is obtainable
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Dissertation supervisor
mehri@tums.ac.ir
+98 21 7753 3939
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What processes are involved for a request to access data/document
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Submitting a request to the dissertation supervisor
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Comments
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