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LEXURE for Post-Stroke Aphasia

12. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

116

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LEXURE
Participants assigned to this arm will receive language training intervention using the LEXURE digital therapeutic (DTx) software.
Enhed: 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..
Aktiv komparator: Workbook
Participants assigned to this arm will receive a language therapy workbook and perform structured language exercises as a control intervention.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in K-WAB or PK-WAB-R Aphasia Quotient (AQ) Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in K-WAB or PK-WAB-R Spontaneous Speech Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nunaps Inc

Efterforskere

  • Studiestol: Sung Il Sohn, MD, PhD, Keimyung University Dongsan Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. april 2026

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

30. december 2026

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NNS-LEX-01

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