Digital speech-therapy app Zenicom for subacute post-stroke aphasia in Korean speakers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-blind, randomized Phase 2 trial will enroll 20 adults with first-ever subacute stroke–related aphasia and randomize them 1:1 to conventional speech therapy alone or conventional therapy plus the Zenicom digital speech-therapy application. The experimental arm receives 30 minutes of conventional speech therapy daily plus an additional digital program during a 2-week treatment period, with language and safety outcomes followed during the overall 6-month trial period. Eligibility requires aphasia confirmed by the PK-WAB-R, Korean as the native language, and onset within 3 months of stroke, and excludes patients with progressive or unstable stroke or other major neuropsychiatric comorbidities. Primary endpoints focus on language function change and device safety to provide exploratory evidence of benefit and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 19 years or older.
* Confirmed by a specialist to have aphasia caused by a stroke lesion.
* First-ever subacute stroke (within 3 months of onset) diagnosed via radiological examination (CT, MRI).
* Diagnosed with aphasia based on the Speech Assessment (PK-WAB-R).
* Whose native language is Korean.

Exclusion Criteria:

* Have progressive or hemodynamically unstable stroke.
* Having other neurological diseases suspected to affect language ability.
* Co-morbid major psychiatric disorders requiring continuous medication (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Dementia).
* Co-morbid major neurogenic diseases other than stroke.
* Confirmed history of degenerative neuropathy.
* Current or past substance or alcohol use disorder.
* Visual impairment (Low vision severity: visual acuity of 0.1-0.3 or lower).
* Intellectual disability.
* Illiteracy (unable to read and consent).

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, South Korea Recruiting
• Konkuk University Medical Center
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Pf. Won Kee Chang, MD, MS
• Email: wkchang@snubh.org
• Phone: +82-31-787-7737

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.