CompletedNot Applicable

Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke

South Korea40 participantsStarted 2022-01-18

Plain-language summary

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.

Who can participate

SexALL

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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.

What they're measuring

Speech intelligibility

Timeframe: Baseline, 4weeks

Trial details

NCT IDNCT05146765

SponsorEwha Womans University Seoul Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-30

View on ClinicalTrials.gov More Dysarthria as Late Effect of Stroke trials