Smartphone-based speech therapy
DeviceParticipants will be instructed to use the speech therapy app for 1 hour per day (5 days for 1 week) over a 4-week period.
NCT Number: NCT05877950
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 4 weeks
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
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
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
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
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
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
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: 4 weeks
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
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.
Contact information is provided by the study sponsor or research team.
Ewha Womans University Seoul Hospital
Other
A Prospective, Randomized, Multi-Centered Clinical Trial to Investigate the Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04427670
Brain Diseases, Cardiovascular Diseases
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT05865106
Dysarthria As Late Effect of Stroke
Seoul, South Korea
View Trial DetailsNCT05146765
Articulation Disorders, Brain Diseases
Seoul, South Korea
View Trial Details