An interventional study of Smartphone-based speech therapy and Traditional speech therapy in Dysarthria As Late Effect of Stroke, sponsored by Ewha Womans University Seoul Hospital. Completed at 1 site in Korea, Republic of. 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 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.
A total of 76 patients with post-stroke dysarthria will be recruited and stratified by the onset period into acute-subacute (within 6month 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. 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. 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.
60 studies on the registry are indexed under Dysarthria; 19 are open to participants now.
This study's enrollment of 76 is above the median of 39 across 44 interventional studies indexed under Dysarthria.
Browse Dysarthria studies →Ewha Womans University Seoul Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Smartphone-based speech therapy
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.
Other: Traditional 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
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
Plan to share: No
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This study is completed, 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