Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria.

Last updated: October 31, 2024
Sponsor: HAII corp.ltd
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Communication Disorders

Speech Disorders

Treatment

Workbook

repeech

Clinical Study ID

NCT06670014
RDKC00
  • Ages > 19
  • All Genders

Study Summary

The goal of this interventional study is to evaluate the efficacy and safety of a digital therapeutic (DTx) application, 'repeech', for the treatment of post-stroke dysarthria. The study aims to assess improvement in speech intelligibility in individuals affected by post-stroke dysarthria using the DTx intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be 19 years of age or older.

  2. Participants must be neurologically stable post-stroke, as determined by a qualifiedphysician.

  3. Participants must have dysarthria due to stroke, with a National Institutes ofHealth Stroke Scale (NIHSS) score 1 (mild) or 2 (moderate) for dysarthria.

  4. participants must have a Korean-Modified Mini-Mental State Examination (K-MMSE)score of 26 or higher within 1 month prior to enrollment in the study.

  5. Participants must have sufficient visual, auditory, langauge, and motor abilities tounderstand and follow the assessment procedures, as determined by the PrincipalInvestigator.

  6. Participants must be able to use general-purpose digital equipment and comfortablewith using the digital therapeutics(DTx) platform for this study.

  7. Participants must provide informed consent after receiving a thorough explanation ofthe study, including potential risks and benefits. They must understand and agree tofollow the study protocol.

Exclusion

Exclusion Criteria:

  1. Participants with sigificant structural problems affecting the oral cavity andcervial region that would hinder accurate assessment.

  2. Participants diagnosed with dementia, including Alzheimer's disease, Vasculardementia, Dementia due to Central Nervous System(CNS) infections (e.g., HIV,syphilis), Creutzfeldt-Jakob disease, Pick's disease, Huntington's disease,Parkinson's disease.

  3. Participants currently receiving treatment for dementia within 3 months prior tostudy screening.

  4. Participants who are unable to read or write in the language of the study.

  5. Participants with severe mental health conditions including severe depression,schizophrenia, alcohol addicsion, drug dependence.

  6. Participants with a severe langauge disorder, as determined by the physician(MD),that would significantly hinder their abiity to use digital therapeutics platform.

  7. Participants deemed by the MD as unable to use general-purpose digital equipment.

  8. Participants with additional medical or social concerns that, in the opinion of thePrindipal Investigator(PI), would make their participation in the clinical trialunsuitable or pose siginficant risks.

  9. Participants who decline to participate in the study.

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Workbook
Phase:
Study Start date:
November 20, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This study will evaluate a digital therapeutic (DTx), 'repeech', designed to complement tradtional speech therapy by addressing challenges such as accessibility, frequency of sessions, and personalized feedback. The 'repeech' offers an at-home, customzied intervention, providing patients with more flexible and accessible therapy options. It also encourage greater patient engagement in their treatment and promotes self-care.

The study is designed to assess the efficacy of the 'repeech' in improving speech function, especially speech intelligibility in individuals with post-stroke dysarthria. The clinical trial will be conducted across multiple sites to gather comprehensive data on the intervention's effectiveness and usability.

Connect with a study center

  • Yongin Severance Hospital

    Yongin, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Mokdong Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Seoul Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • KyunHee University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • National Rehabilitation Center

    Seoul,
    Korea, Republic of

    Site Not Available

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