LEXURE for Post-Stroke Aphasia
ConditionAphasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNunaps Inc
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
LEXURE
DeviceParticipants 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..
Workbook
BehavioralParticipants 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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: LEXUREExperimental treatment 1 intervention
Group B: WorkbookActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
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.
Time frame
Baseline to Week 10Secondary outcomes
1
Change in K-WAB or PK-WAB-R Spontaneous Speech Score
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.
Time frame
Baseline to Week 102
Change in K-WAB or PK-WAB-R Auditory Comprehension Score
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.
Time frame
Baseline to Week 103
Change in K-WAB or PK-WAB-R Repetition Score
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.
Time frame
Baseline to Week 104
Change in K-WAB or PK-WAB-R Naming and Word Finding Score
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.
Time frame
Baseline to Week 10 Source ClinicalTrials.gov