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LEXURE for Post-Stroke Aphasia

2026年5月12日 更新者：Nunaps Inc

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 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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

116

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 韩国
      • Busan、韩国、47392
        • 招聘中
        • Inje University Busan Paik Hospita
        • 接触：
          • Eung-Gyu Kim, MD, PhD
      • Chuncheon、韩国、24253
        • 招聘中
        • Hallym University Chuncheon Sacred Heart Hospital
        • 接触：
          • Chulho Kim, MD, PhD
      • Daegu、韩国、42601
        • 招聘中
        • Keimyung University Dongsan Hospital
        • 接触：
          • Sung Il Sohn, MD, PhD
      • Daegu、韩国、42415
        • 尚未招聘
        • Yeungnam University Medical Center
        • 接触：
          • Jun Lee, MD, PhD
      • Daegu、韩国、41944
        • 尚未招聘
        • Kyungpook National University Hospital
        • 接触：
          • Yangha Hwang, MD, PhD
      • Gwangju、韩国、61469
        • 招聘中
        • Chonnam National University Hospital
        • 接触：
          • Man Seok Park, MD, PhD
      • Ilsan、韩国、10380
        • 招聘中
        • Inje University Ilsan Paik Hospital
        • 接触：
          • Keun-Sik Hong, MD, PhD
      • Jeonju、韩国、54907
        • 尚未招聘
        • Jeonbuk National University Hospital
        • 接触：
          • Hyun Goo Kang, MD, PhD
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
        • 接触：
          • Jun Young Chang, MD, PhD
      • Seoul、韩国
        • 招聘中
        • Konkuk University Medical Center
        • 接触：
          • Hahn Young Kim, MD, PhD
      • Ulsan、韩国、44033
        • 招聘中
        • Ulsan University Hospital
        • 接触：
          • Jee-Hyun Kwon, MD, PhD
    • Gyeonggi-do
      • Ansan、Gyeonggi-do、韩国、15355
        • 尚未招聘
        • Korea University Ansan Hospital
        • 接触：
          • Jin-Man Jung, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：LEXURE
Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.
设备：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..
有源比较器：Workbook
Participants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
大体时间：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.
Baseline to Week 10

次要结果测量

结果测量
措施说明
大体时间
Change in K-WAB or PK-WAB-R Spontaneous Speech Score
大体时间：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.
Baseline to Week 10
Change in K-WAB or PK-WAB-R Auditory Comprehension Score
大体时间：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.
Baseline to Week 10
Change in K-WAB or PK-WAB-R Repetition Score
大体时间：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.
Baseline to Week 10
Change in K-WAB or PK-WAB-R Naming and Word Finding Score
大体时间：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.
Baseline to Week 10
Mean change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) in the study group
大体时间：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.
Baseline to Week 10

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nunaps Inc

调查人员

  • 学习椅：Sung Il Sohn, MD, PhD、Keimyung University Dongsan Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月16日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年5月14日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NNS-LEX-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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