Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke (NCT05146765) | Clinical Trial Compass
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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.