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The Effectiveness of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria

Primary Purpose

Dysarthria as Late Effect of Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smartphone-based speech therapy
Home-based speech therapy
Sponsored by
Ewha Womans University Seoul Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysarthria as Late Effect of Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 or over. Neurologically stable stroke patients diagnosed by a stroke specialist neurologist. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist. First-ever stroke patients without previous stroke history. Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26) As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions. Exclusion Criteria: Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist. Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism). Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction). Patients taking concomitant medications that could affect the trial results during the study period (e.g., cognitive dysfunction medications, anticholinergics, anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, and hypnotics). Patients unable to use/access smartphone technology. Illiterate patients. Patients unable to communicate in Korean. Is unsuitable for participation due to other reasons, as determined by the investigator. Has refused to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Smartphone-based speech therapy with usual stroke care

    Home-based speech therapy with usual stroke care

    Arm Description

    Smartphone-based speech therapy: Participants will be instructed to use smartphone-based speech therapy (application), including oro-motor exercises, phonation, articulation, resonance, syllable repetition, and reading exercises. Usual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.

    Home-based speech therapy: Participants will receive treatment such as oro-motor exercises and reading tasks from a workbook. Usual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.

    Outcomes

    Primary Outcome Measures

    Speech intelligibility
    The change in speech intelligibility from baseline to 4 weeks post-intervention will be assessed. Speech intelligibility will be evaluated by having three naive listeners transcribe the participants' recorded speech. These transcriptions will then be compared to the original sentences to calculate a percentage score representing intelligibility. The final intelligibility score will be calculated as the average of the scores from the three naive listeners. A higher percentage indicates greater speech intelligibility.

    Secondary Outcome Measures

    Maximum phonation Time (MPT)
    The change in maximum phonation time (MPT) from baseline to 4 weeks post-intervention will be assessed. MPT will be used to assess participants' maximum phonation time. The speech evaluator instructs the patient to take a comfortable breath and then produce the sound /a/ for as long as possible. The task is performed twice, and the maximum duration of the two measurements is used.
    Oral-diadochokinesis (DDK)
    The Oral-diadochokinesis (DDK) change from baseline to 4 weeks post-intervention will be assessed. DDK will be used to assess articulation rate, regularity, and accuracy. Participants are instructed to repeat the syllables /pa/, /ta/, /ka/, and /pataka/ as quickly and accurately as possible. The number of repetitions is divided by the duration of the task.
    Percentage of Consonants Correct (PCC, %)
    The Percentage of Consonants Correct (PCC, %) change from baseline to 4 weeks post-intervention will be assessed. PCC is evaluated as a percentage score calculated from the Urimal Test of Articulation and Phonology 2 (UTAP2).

    Full Information

    First Posted
    May 8, 2023
    Last Updated
    May 17, 2023
    Sponsor
    Ewha Womans University Seoul Hospital
    Collaborators
    Ewha Womans University Mokdong Hospital, National Rehabilitation Center, Seoul, Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05877950
    Brief Title
    The Effectiveness of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria
    Official Title
    A Prospective, Randomized, Multi-Centered Clinical Trial to Investigate the Effectiveness of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ewha Womans University Seoul Hospital
    Collaborators
    Ewha Womans University Mokdong Hospital, National Rehabilitation Center, Seoul, Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This clinical trial aims to determine if a new smartphone-based speech therapy is effective self-treatment method for patients with post-stroke dysarthria. For this study, participants in the intervention group will use the speech therapy app for 1 hour per day, 5 days per week, over a 4-week period. The active control group will receive home-based speech therapy with the same duration and frequency as the intervention group. The study will help us understand if smartphone-based speech therapy is a viable treatment option for post-stroke dysarthria patients.
    Detailed Description
    In this study, 100 patients with post-stroke dysarthria will be recruited and stratified into acute-subacute (within 1 month after index stroke) and chronic (after 6 months after index stroke) groups. Participants will then be randomly assigned to either the intervention or active control group. Patients in the intervention group will use a smartphone-based speech therapy app that includes oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercises. Treatment goals and contents will be determined based on individual patient conditions by a speech-language pathologist after the baseline evaluation. Participants will receive daily sessions for 1 hour per day, 5 days per week, over a 4-week period. Patients in the active control group will receive home-based speech therapy, which includes oro-motor exercises and reading tasks from a workbook, for the same frequency as the intervention group. Both groups will also receive usual stroke care. The study aims to evaluate the efficacy of mobile-based speech therapy compared to home-based speech therapy in improving speech intelligibility scores 4 weeks after baseline for patients with dysarthria in the acute-subacute and chronic phases following stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysarthria as Late Effect of Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Smartphone-based speech therapy with usual stroke care
    Arm Type
    Experimental
    Arm Description
    Smartphone-based speech therapy: Participants will be instructed to use smartphone-based speech therapy (application), including oro-motor exercises, phonation, articulation, resonance, syllable repetition, and reading exercises. Usual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
    Arm Title
    Home-based speech therapy with usual stroke care
    Arm Type
    Active Comparator
    Arm Description
    Home-based speech therapy: Participants will receive treatment such as oro-motor exercises and reading tasks from a workbook. Usual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
    Intervention Type
    Device
    Intervention Name(s)
    Smartphone-based speech therapy
    Intervention Description
    Participants will be instructed to use the speech therapy app for 1 hour per day (5 days for 1 week) over a 4-week period.
    Intervention Type
    Other
    Intervention Name(s)
    Home-based speech therapy
    Intervention Description
    Participants will receive treatment maintaining the same frequency as the intervention group.
    Primary Outcome Measure Information:
    Title
    Speech intelligibility
    Description
    The change in speech intelligibility from baseline to 4 weeks post-intervention will be assessed. Speech intelligibility will be evaluated by having three naive listeners transcribe the participants' recorded speech. These transcriptions will then be compared to the original sentences to calculate a percentage score representing intelligibility. The final intelligibility score will be calculated as the average of the scores from the three naive listeners. A higher percentage indicates greater speech intelligibility.
    Time Frame
    Baseline, 4 weeks
    Secondary Outcome Measure Information:
    Title
    Maximum phonation Time (MPT)
    Description
    The change in maximum phonation time (MPT) from baseline to 4 weeks post-intervention will be assessed. MPT will be used to assess participants' maximum phonation time. The speech evaluator instructs the patient to take a comfortable breath and then produce the sound /a/ for as long as possible. The task is performed twice, and the maximum duration of the two measurements is used.
    Time Frame
    Baseline, 4 weeks
    Title
    Oral-diadochokinesis (DDK)
    Description
    The Oral-diadochokinesis (DDK) change from baseline to 4 weeks post-intervention will be assessed. DDK will be used to assess articulation rate, regularity, and accuracy. Participants are instructed to repeat the syllables /pa/, /ta/, /ka/, and /pataka/ as quickly and accurately as possible. The number of repetitions is divided by the duration of the task.
    Time Frame
    Baseline, 4 weeks
    Title
    Percentage of Consonants Correct (PCC, %)
    Description
    The Percentage of Consonants Correct (PCC, %) change from baseline to 4 weeks post-intervention will be assessed. PCC is evaluated as a percentage score calculated from the Urimal Test of Articulation and Phonology 2 (UTAP2).
    Time Frame
    Baseline, 4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Patient Health Questionnaire-9 (PHQ-9)
    Description
    PHQ-9 will be used to assess depression. The PHQ-9 is a nine-item self-reported questionnaire for the measurement of depressive symptoms during the last two weeks.
    Time Frame
    Baseline, 4 weeks
    Title
    Quality of Life in the Dysarthric Speaker (QOL-Dys)
    Description
    QOL-Dys will be used to assess the comprehensive quality of life of individuals with dysarthria. The questionnaire consists of four dimensions: characteristics of speech, situational difficulties, use of compensation strategies, and perception of others. The responses are rated on a 5-point scale from 0 to 4, indicating the extent to which participants agree with each statement.
    Time Frame
    Baseline, 4 weeks
    Title
    Communicative Effectiveness Survey (CES)
    Description
    CES will be used to assess the communication efficiency of individuals with dysarthria in daily situations. The rating scale consists of 8 items and uses a 7-category rating scale ranging from "1 = not effective at all" to "7 = extremely effective" for everyday speaking situations.
    Time Frame
    Baseline, 4 weeks
    Title
    System Usability Questionnaire (SUS)
    Description
    SUS will be used to assess user's subjective views of a system's usability. SUS will only be used in the intervention group at the end of treatment.
    Time Frame
    4 weeks
    Title
    Application usage logs
    Description
    The log data will be used to evaluate compliance and acoustic factors. During the 4-week experimental period, the application login time, daily task completion rate, and raw data (.wav) of patients' voices are stored on the server for analysis.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 or over. Neurologically stable stroke patients diagnosed by a stroke specialist neurologist. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist. First-ever stroke patients without previous stroke history. Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26) As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions. Exclusion Criteria: Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist. Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism). Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction). Patients taking concomitant medications that could affect the trial results during the study period (e.g., cognitive dysfunction medications, anticholinergics, anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, and hypnotics). Patients unable to use/access smartphone technology. Illiterate patients. Patients unable to communicate in Korean. Is unsuitable for participation due to other reasons, as determined by the investigator. Has refused to participate in the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effectiveness of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria

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