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

Not Applicable
Not yet recruiting
Conditions
Dysarthria As Late Effect of Stroke
Registration Number
NCT05877950
Lead Sponsor
Ewha Womans University Seoul Hospital
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  1. Aged 18 or over.
  2. Neurologically stable stroke patients diagnosed by a stroke specialist neurologist.
  3. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
  4. First-ever stroke patients without previous stroke history.
  5. Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26)
  6. As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study
  7. Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions.
Exclusion Criteria
  1. Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist.
  2. Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
  3. Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).
  4. 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).
  5. Patients unable to use/access smartphone technology.
  6. Illiterate patients.
  7. Patients unable to communicate in Korean.
  8. Is unsuitable for participation due to other reasons, as determined by the investigator.
  9. Has refused to participate in the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Speech intelligibilityBaseline, 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.

Secondary Outcome Measures
NameTimeMethod
Maximum phonation Time (MPT)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.

Oral-diadochokinesis (DDK)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.

Percentage of Consonants Correct (PCC, %)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).

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