LEXURE digital language therapy for post-stroke aphasia
A Prospective, Multicenter, Randomized, Evaluator-Blinded, Confirmatory Study to Evaluate the Efficacy and Safety of LEXURE for Improving Language Function in Patients With Post-Stroke Aphasia
This trial will test whether using the LEXURE app helps adults with post-stroke aphasia improve language more than workbook-based practice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Nunaps Inc Industry-sponsored |
| Locations | 12 sites (Ansan, Gyeonggi-do and 11 other locations) |
| Trial ID | NCT07570264 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, evaluator-blinded confirmatory trial comparing a digital therapeutic (LEXURE) to a workbook-based active comparator in people with post-stroke aphasia. Eligible adults (≥19 years) at least 3 months after ischemic or hemorrhagic stroke with an Aphasia Quotient of 26–90 will be randomized 1:1. The LEXURE group will do ~30-minute digital training sessions five times weekly for 10 weeks while the control group will follow matched workbook tasks on the same schedule. Primary outcomes use the K-WAB/PK-WAB-R scored by independent, blinded assessors to measure language change and safety over the intervention period.
Who should consider this trial
Good fit: Adults (19+) who are native Korean speakers with post-stroke aphasia at least 3 months after stroke and an AQ score of 26–90 who can use the app or complete workbook tasks are ideal candidates.
Not a fit: People whose language problems are due to non-stroke causes (e.g., traumatic brain injury, tumor, neurodegenerative disease), developmental language disorders, or who are already receiving active speech-language therapy or a related clinical trial are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, LEXURE could improve language recovery and increase access to structured speech practice by providing scalable digital therapy.
How similar studies have performed: Smaller studies of digital and structured therapy approaches for post-stroke aphasia have shown promising results, but large confirmatory trials comparing digital tools to active workbook-based interventions remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with hemorrhagic or ischemic stroke 2. At least 3 months have elapsed since stroke onset 3. History of aphasia resulting from stroke 4. Aphasia Quotient (AQ) score between 26 and 90 (inclusive) on the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R) 5. Adults aged 19 years or older 6. Native Korean speakers 7. Able to use the investigational device or perform workbook-based training without difficulty 8. Willing to participate voluntarily and provide written informed consent Exclusion Criteria: 1. Diagnosed with language impairment due to causes other than stroke (e.g., traumatic brain injury, brain tumor, or neurodegenerative disease) 2. History of language impairment due to developmental disorders 3. Currently receiving speech-language therapy or participating in another clinical trial related to language function 4. Currently receiving medication for severe psychiatric disorders (e.g., bipolar disorder, major depressive disorder, schizophrenia, alcohol dependence, or substance abuse) 5. Illiterate individuals 6. Individuals deemed unsuitable for participation in this study by the investigator 7. Severe cognitive impairment that would interfere with understanding or performing the study interventions
Where this trial is running
Ansan, Gyeonggi-do and 11 other locations
- Korea University Ansan Hospital — Ansan, Gyeonggi-do, South Korea (Not_yet_recruiting)
- Inje University Busan Paik Hospita — Busan, South Korea (Recruiting)
- Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, South Korea (Recruiting)
- Kyungpook National University Hospital — Daegu, South Korea (Not_yet_recruiting)
- Yeungnam University Medical Center — Daegu, South Korea (Not_yet_recruiting)
- Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
- Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
- Inje University Ilsan Paik Hospital — Ilsan, South Korea (Recruiting)
- Jeonbuk National University Hospital — Jeonju, South Korea (Not_yet_recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Konkuk University Medical Center — Seoul, South Korea (Recruiting)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
Study contacts
- Study coordinator: Suekyung Jung
- Email: skjung@nunaps.com
- Phone: +82-2-488-6542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.