Clinical trial NCT05877950: The Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
Official title: A Prospective, Randomized, Multi-Centered Clinical Trial to Investigate the Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysarthria As Late Effect of Stroke
Lead sponsor: Ewha Womans University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Ewha Womans University Mokdong Hospital
name: National Rehabilitation Center, Seoul, Korea
First posted: 2023-05-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Speech intelligibility
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Maximum phonation Time (MPT)
timeFrame: Baseline, 4 weeks
measure: Oral-diadochokinesis (DDK)
timeFrame: Baseline, 4 weeks
measure: Percentage of Consonants Correct (PCC, %)
timeFrame: Baseline, 4 weeks
Other outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 4 weeks
measure: Quality of Life in the Dysarthric Speaker (QOL-Dys)
timeFrame: Baseline, 4 weeks
measure: Communicative Effectiveness Survey (CES)
timeFrame: Baseline, 4 weeks
measure: System Usability Questionnaire (SUS)
timeFrame: 4 weeks
measure: Application usage logs
timeFrame: 4 weeks
Locations:
Study officials:
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