An interventional study of Smartphone-based speech therapy and Home-based speech therapy in Dysarthria As Late Effect of Stroke, sponsored by Ewha Womans University Seoul Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by Ewha Womans University Seoul Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Device: Smartphone-based speech therapy
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.
Other: Home-based speech therapy
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.
Participants will receive treatment maintaining the same frequency as the intervention group.
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.
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
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).
Time frame: Baseline, 4 weeks
Patient Health Questionnaire-9 (PHQ-9)
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
Quality of Life in the Dysarthric Speaker (QOL-Dys)
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
Communicative Effectiveness Survey (CES)
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
System Usability Questionnaire (SUS)
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
Application usage logs
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
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Ewha Womans University Seoul Hospital