LEXURE for Post-Stroke Aphasia: A Randomized, Evaluator-Blinded, Confirmatory Trial
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
Nunaps Inc
116 participants
Apr 16, 2026
INTERVENTIONAL
Conditions
Summary
This study evaluates the efficacy of digital language rehabilitation using LEXURE for the treatment of post-stroke aphasia. Half of participants will receive structured language training using the LEXURE application, while the other half will receive workbook-based language training as an active comparator.
Eligibility
Inclusion Criteria8
- Diagnosed with hemorrhagic or ischemic stroke
- At least 3 months have elapsed since stroke onset
- History of aphasia resulting from stroke
- 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)
- Adults aged 19 years or older
- Native Korean speakers
- Able to use the investigational device or perform workbook-based training without difficulty
- Willing to participate voluntarily and provide written informed consent
Exclusion Criteria7
- Diagnosed with language impairment due to causes other than stroke (e.g., traumatic brain injury, brain tumor, or neurodegenerative disease)
- History of language impairment due to developmental disorders
- Currently receiving speech-language therapy or participating in another clinical trial related to language function
- Currently receiving medication for severe psychiatric disorders (e.g., bipolar disorder, major depressive disorder, schizophrenia, alcohol dependence, or substance abuse)
- Illiterate individuals
- Individuals deemed unsuitable for participation in this study by the investigator
- Severe cognitive impairment that would interfere with understanding or performing the study interventions
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Interventions
Participants will undergo a total of 50 training sessions, conducted 5 times per week for 10 weeks. Each session consists of five training tasks and takes approximately 30 minutes to complete..
Participants will perform language training using a workbook. Training will be conducted 5 times per week for 10 weeks, with each session lasting approximately 30 minutes.
Locations(12)
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NCT07570264