LEXURE for Post-Stroke Aphasia
2026년 5월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
116
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Suekyung Jung
- 전화번호: +82-2-488-6542
- 이메일: skjung@nunaps.com
연구 장소
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Busan, 대한민국, 47392
- 모병
- Inje University Busan Paik Hospita
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연락하다:
- Eung-Gyu Kim, MD, PhD
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Chuncheon, 대한민국, 24253
- 모병
- Hallym University Chuncheon Sacred Heart Hospital
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연락하다:
- Chulho Kim, MD, PhD
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Daegu, 대한민국, 42601
- 모병
- Keimyung University Dongsan Hospital
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연락하다:
- Sung Il Sohn, MD, PhD
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Daegu, 대한민국, 42415
- 아직 모집하지 않음
- Yeungnam University Medical Center
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연락하다:
- Jun Lee, MD, PhD
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Daegu, 대한민국, 41944
- 아직 모집하지 않음
- Kyungpook National University Hospital
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연락하다:
- Yangha Hwang, MD, PhD
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Gwangju, 대한민국, 61469
- 모병
- Chonnam National University Hospital
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연락하다:
- Man Seok Park, MD, PhD
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Ilsan, 대한민국, 10380
- 모병
- Inje University Ilsan Paik Hospital
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연락하다:
- Keun-Sik Hong, MD, PhD
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Jeonju, 대한민국, 54907
- 아직 모집하지 않음
- Jeonbuk National University Hospital
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연락하다:
- Hyun Goo Kang, MD, PhD
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Seoul, 대한민국, 05505
- 모병
- Asan Medical Center
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연락하다:
- Jun Young Chang, MD, PhD
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Seoul, 대한민국
- 모병
- Konkuk University Medical Center
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연락하다:
- Hahn Young Kim, MD, PhD
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Ulsan, 대한민국, 44033
- 모병
- Ulsan University Hospital
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연락하다:
- Jee-Hyun Kwon, MD, PhD
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Gyeonggi-do
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Ansan, Gyeonggi-do, 대한민국, 15355
- 아직 모집하지 않음
- Korea University Ansan Hospital
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연락하다:
- Jin-Man Jung, MD, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- 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 Criteria:
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: LEXURE
Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.
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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..
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활성 비교기: Workbook
Participants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
기간: Baseline to Week 10
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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.
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Baseline to Week 10
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in K-WAB or PK-WAB-R Spontaneous Speech Score
기간: Baseline to Week 10
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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.
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Baseline to Week 10
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Change in K-WAB or PK-WAB-R Auditory Comprehension Score
기간: Baseline to Week 10
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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.
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Baseline to Week 10
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Change in K-WAB or PK-WAB-R Repetition Score
기간: Baseline to Week 10
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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.
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Baseline to Week 10
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Change in K-WAB or PK-WAB-R Naming and Word Finding Score
기간: Baseline to Week 10
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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.
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Baseline to Week 10
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Mean change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) in the study group
기간: Baseline to Week 10
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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.
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Baseline to Week 10
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 의자: Sung Il Sohn, MD, PhD, Keimyung University Dongsan Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 4월 16일
기본 완료 (추정된)
2026년 12월 30일
연구 완료 (추정된)
2026년 12월 30일
연구 등록 날짜
최초 제출
2026년 4월 29일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .