LEXURE for Post-Stroke Aphasia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство LEXURE
  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..
• Поведенческое Workbook
  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.

Первичные конечные точки

• Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score [Срок оценки: Baseline to Week 10]

Вторичные конечные точки (5)

• Change in K-WAB or PK-WAB-R Spontaneous Speech Score [Срок оценки: Baseline to Week 10]
• Change in K-WAB or PK-WAB-R Auditory Comprehension Score [Срок оценки: Baseline to Week 10]
• Change in K-WAB or PK-WAB-R Repetition Score [Срок оценки: Baseline to Week 10]
• Change in K-WAB or PK-WAB-R Naming and Word Finding Score [Срок оценки: Baseline to Week 10]
• Mean change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) in the study group [Срок оценки: Baseline to Week 10]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 12 центров

• Korea University Ansan Hospital — Ansan
• Inje University Busan Paik Hospita — Busan
• Hallym University Chuncheon Sacred Heart Hospital — Chuncheon
• Kyungpook National University Hospital — Daegu
• Yeungnam University Medical Center — Daegu
• Keimyung University Dongsan Hospital — Daegu
• Chonnam National University Hospital — Gwangju
• Inje University Ilsan Paik Hospital — Ilsan
• … и ещё 4 центра

Идентификаторы

NCT: NCT07570264 · NNS-LEX-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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