Back to resultsThe Efficacy and Feasibility 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
Traditional speech therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dysarthria as Late Effect of Stroke
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Smartphone-based speech therapy with usual stroke care
Traditional 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. Treatment as usual: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
Traditional speech therapy: Traditional speech therapy methods, such as face-to-face sessions, oro-motor exercises for the tongue, lips, chin, and jaw, reading aloud slowly and clearly, and practicing proper breathing and sustained speech, will be employed. Treatment as usual: 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
NCT ID
NCT05865106
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
1. Study Identification
Unique Protocol Identification Number
NCT05865106
Brief Title
The Efficacy and Feasibility of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria
Official Title
A Prospective, Randomized, Multi-Center Pilot Trial to Evaluate the Efficacy and Feasibility 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 and feasible for patients with post-stroke dysarthria. 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 control group will receive the same duration and frequency of traditional speech therapy 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
A total of 64 patients with post-stroke dysarthria will be recruited and stratified by the onset period into acute-subacute (within 1 month after index stroke) and chronic (after 6 months after index stroke). Then participants are randomly divided into intervention and control groups.
Patients in the intervention group will be instructed to use smartphone-based speech therapy applications, including oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercises with usual stroke care. After the baseline evaluation, treatment goals, and contents will be determined with a speech-language pathologist according to the condition of individual patients. Daily sessions will be provided for 1 hour per day, 5 days per week, over a 4-week period.
Patients in the control group will be instructed to receive traditional speech therapy with usual stroke care. Traditional speech therapy can include face-to-face speech therapy, including oro-motor exercises, reading aloud slowly and clearly, and practicing proper breathing and sustained speech. To maintain the same dose and frequency as the intervention group, 60 minutes of treatment will be performed five days a week (e.g., two days of face-to-face speech therapy per week (60 minutes) + three days of self-training through the reading task workbook (60 minutes).
The aim of the study is to establish smartphone-based speech therapy is non-inferior to traditional speech therapy for improving speech intelligibility.
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
64 (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.
Treatment as usual: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
Arm Title
Traditional speech therapy with usual stroke care
Arm Type
Other
Arm Description
Traditional speech therapy: Traditional speech therapy methods, such as face-to-face sessions, oro-motor exercises for the tongue, lips, chin, and jaw, reading aloud slowly and clearly, and practicing proper breathing and sustained speech, will be employed.
Treatment as usual: 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)
Traditional 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 Efficacy and Feasibility of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria
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