Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke

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.

Inclusion criteria

• Neurologically stable, as determined by the clinician.
• Onset of stroke within four weeks prior to randomization.
• Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
• Maintains enough cognitive function to use the speech therapy application without problems, as determined by a Mini-Mental State Exam score of 26 ≥ within 1 month prior to randomization.
• Capable of walking or moving alone or with the assistance of a walking aid (e.g., walkers, canes, or wheelchairs).
• Must have intact vision, hearing, communication skills, and motor skills, as well as comprehension sufficient to proceed with assessment, as judged by the clinician.

Exclusion criteria

• Unable to measure articulatory or orofacial functions due to organic causes/lesions in articulatory and cervical structure.
• Has comorbid neurological conditions that, in the opinion of the investigator, could impair study participation, such as dementia (Alzheimer's disease, vascular dementia, Central Nervous System Infection [e.g., Human Immunodeficiency Virus, syphilis], Creutzfeld-Jacob disease, etc.), Pick's disease, Huntington's disease, or Parkinson's disease.
• Has a Mini-Mental State Exam score of 26 or below at the time of screening.
• Has a Clinical Dementia Rating score of 1 ≥ or a Global Deterioration Scale score of 3 ≥ at the time of screening.
• Received dementia treatment within 3 months of screening.
• Takes medication that may impact cognitive function during the clinical trial period.
• Co-medication is prohibited during the entire trial period for the following medications: drugs for dementia treatment, Central Nervous System stimulants, anticholinergics, tricyclic antidepressants, typical antipsychotics, and sleeping pills (excluding rapid-acting sleeping pills).
• Co-medication is permitted if continued use of the following medications has been at a stable dose for 2 months prior to randomization: atypical antipsychotics, anxiolytics, antidepressants (excluding tricyclic antidepressants), thyroid hormone, and rapid-acting sleeping pills.
• Is uneducated or illiterate.
• Has been diagnosed with a serious mental illness such as severe depression, schizophrenia, alcohol addiction, or drug addiction.
• Unable to use D-ST01 due to severe speech impairment, as determined by the clinician.