Aphasia
Conditions
Keywords
aphasia, stroke
Brief 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.
Detailed description
This study is a prospective, multicenter, randomized, evaluator-blinded confirmatory clinical trial designed to evaluate the efficacy and safety of LEXURE, a digital therapeutic for language in patients with post-stroke aphasia. Eligible participants who provide informed consent will undergo screening and be randomized in a 1:1 ratio to either the LEXURE group or the control group. LEXURE Group: Participants assigned to the LEXURE group will receive structured digital language training using the LEXURE application. The training consists of multiple language tasks and will be performed for approximately 30 minutes per session, 5 times per week, for 10 weeks. Control Group: Participants assigned to the control group will perform structured language training using a workbook-based intervention. The training will consist of predefined language tasks and will be conducted for approximately 30 minutes per session, 5 times per week, for 10 weeks. The primary efficacy endpoint will be assessed using the K-WAB/PK-WAB-R, and evaluations will be conducted by an independent, evaluator-blinded assessor.
Interventions
DEVICELEXURE
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..
BEHAVIORALWorkbook
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.
Sponsors
Nunaps Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score | Baseline to Week 10 | Change in Aphasia Quotient (AQ) score from baseline to Week 10, measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). AQ scores range from 0 to 100, with higher scores indicating better language function. Assessments will be conducted by an independent, evaluator-blinded assessor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in K-WAB or PK-WAB-R Spontaneous Speech Score | Baseline to Week 10 | Change from baseline to Week 10 in Spontaneous Speech score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better expressive language ability. Assessments will be conducted by an independent, evaluator-blinded assessor. |
| Change in K-WAB or PK-WAB-R Auditory Comprehension Score | Baseline to Week 10 | Change from baseline to Week 10 in Auditory Comprehension score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better language comprehension ability. Assessments will be conducted by an independent, evaluator-blinded assessor. |
| Change in K-WAB or PK-WAB-R Repetition Score | Baseline to Week 10 | Change from baseline to Week 10 in Repetition score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better verbal repetition ability. Assessments will be conducted by an independent, evaluator-blinded assessor. |
| Change in K-WAB or PK-WAB-R Naming and Word Finding Score | Baseline to Week 10 | Change from baseline to Week 10 in Naming and Word Finding score measured using the Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R). Higher scores indicate better lexical retrieval ability. Assessments will be conducted by an independent, evaluator-blinded assessor. |
| Mean change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) in the study group | Baseline to Week 10 | Mean change from baseline to Week 10 in Korean version of the Western Aphasia Battery (K-WAB) or the Paradise Korean version of the Western Aphasia Battery-Revised (PK-WAB-R) Aphasia Quotient (AQ) score in the study group. The AQ score reflects overall language function. Higher scores indicate better overall language function. Assessments will be conducted by an independent, evaluator-blinded assessor. |
Countries
South Korea
Contacts
CONTACTSuekyung Jung
STUDY_CHAIRSung Il Sohn, MD, PhD
Keimyung University Dongsan Medical Center
Outcome results
None listed