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This pilot trial will establish the feasibility of a new digitized speech rehabilitation developed for patients with post-stroke dysarthria. For this study, participants will be instructed to use the speech therapy app for 30 minutes to 1 hour per day over a 4-week period.
A total of 40 patients with post-stroke dysarthria will be recruited and randomly divided into intervention and control groups.
Patients in the intervention group will be instructed to receive speech treatments including oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercise (App on mobile devices). Daily sessions will be provided during a 4-week period. Both groups will also receive treatment as usual. The aim of the study is to investigate the efficacy of mobile-based speech therapy in patients with dysarthria in the acute phase following stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention group will receive treatment as usual along with the speech therapy app. |
|
| Control | No Intervention | The control group will receive treatment as usual only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile application | Device | Device: Use of mobile application Participants will be instructed to use the speech therapy app for 30 minutes to one hour per day over a 4-week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech intelligibility | Speech intelligibility is evaluated with a score of 0 (normal), 1 (intelligible, some differences noticeable), 2 (intelligible, noticeably different), 3 (intelligible with careful listening, some unintelligible), 4 (difficult to understand, many words unintelligible), 5 (usually unintelligible), or 6 (unintelligible). | Baseline, 4weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2) | he UTAP2, an essential tool for determining articulatory proficiency, will be employed to evaluate the Percentage of Consonants Correct (PCC), a crucial metric for identifying irregularities in articulation. Study participants will be instructed to read all 30 words from the UTAP2 word-level test. Following this, evaluators will calculate the PCC, expressed as a percentage, using the 94 consonants included in these words. This methodology acknowledges that a PCC of 0% signifies lower articulatory accuracy, whereas a PCC of 100% reflects a higher level of precision. |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) | NIHSS will be used to assess stroke-related neurologic deficits. The NIHSS scale is made up of 11 different elements that evaluate specific abilities; level of consciousness (LOC), best gaze, visual field, facial palsy, motor arm, motor leg, limb ataxia, sensory, best language, dysarthria, extinction, inattention. The score ranges from 0 to 42; higher scores indicate more severe stroke symptoms. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae-Jin Song, MD, PhD | Department of Neurology, Ewha University College of Medicine, Seoul, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Medical Center | Seoul | 07804 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38509662 | Derived | Kim Y, Kim M, Kim J, Song TJ. Smartphone-Based Speech Therapy for Poststroke Dysarthria: Pilot Randomized Controlled Trial Evaluating Efficacy and Feasibility. J Med Internet Res. 2024 Apr 25;26:e56417. doi: 10.2196/56417. |
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| ID | Term |
|---|---|
| D004401 | Dysarthria |
| D020521 | Stroke |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| ID | Term |
|---|---|
| D001184 | Articulation Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Pilot trial
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Outcome Assessor
| Treatment as usual | Other | The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines. |
|
| Baseline, 4weeks |
| Baseline, 4weeks |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a nine-item self-reported questionnaire that is used to assess depressive symptoms. The score ranges from 0 to 27, with lower scores indicating less depressive severity. | Baseline, 4weeks |
| Generalized Anxiety disorder-7 | GAD-7(Generalized Anxiety disorder-7) will be used to assess anxiety. The GAD-7(Generalized Anxiety disorder-7) is a seven-item self-reported questionnaire that evaluates anxiety symptoms. The score ranges from 0 to 21, with lower scores indicating lower anxiety symptoms. | Baseline, 4weeks |
| Euro Quality of Life (EQ-5D) | EQ-5D will be used to assess the quality of life. The EQ-5D is a self-report questionnaire that measures health-related quality of life. The questionnaire consists of five dimensions: mobility, self-care, ordinary activities, discomfort, and mood state related to anxiety or depression. The responses indicate three levels of severity ("no problems", "some problems", and "extreme problems") within each EQ-5D dimension. | Baseline, 4weeks |
| Modified Computer Self-Efficacy Scale (mCSES) | mCSES will be used to assess participants' perceptions of self-efficacy with respect to using a computerized system. The mCSES is a 10-item self-reported questionnaire. The score ranges from 0 to 100; higher scores indicate a stronger sense of personal competence. | Baseline, 4weeks |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |