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NCT06670014Completed

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

A Randomized, Parallel-Group, Assessor-Blind, Multi-Center, Non-Inferiority Pivotal Study to Evaluate the Efficacy and Safety of the Digital Therapeutics 'Repeech' for the Post-Stroke Dysarthria.

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
108 (actual)
First submitted
22 Oct 2024
Start date
20 Nov 2024
Primary completion date
17 Oct 2025
Lead sponsor
HAII corp.ltd
Diseases
Stroke
NCT number
NCT06670014

What you commit to

  • Study type: Interventional
  • Participants enrolled: 108
  • From 20 Nov 2024 to the primary completion date, 17 Oct 2025
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants diagnosed with dementia or who used medication for dementia within 3 months before screening.

Other illness

  • Participants with severe psychiatric illness, such as major depression, schizophrenia, or drug dependence.
  • Participants with severe language impairment that would prevent use of the digital application.

Other

  • Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment.
  • Participants who are illiterate.
  • Participants with any other clinical reason that, in the investigator's judgment, would make participation unsuitable.

Who the study is looking for

  • Participants must be 19 years of age or older.
  • Participants must be neurologically stable after stroke, as determined by a qualified physician.
  • Participants must have objective post-stroke dysarthria, defined as a score of 1 or 2 on the dysarthria item of the National Institutes of Health Stroke Scale (NIHSS).
  • Participants must have a Korean Mini-Mental State Examination (K-MMSE) score of 26 or higher within 1 month before study entry.
  • Participants must have sufficient vision, hearing, and motor function to complete the study procedures.
  • Participants must be able to use a tablet PC without difficulty.
  • Participants must provide voluntary written informed consent.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kyunghee university hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
National Rehabilitation Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Ewha Womans University Mokdong Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Ewha Womans University Seoul Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Yongin Severance Hospital
Coordinator of this site? Confirm its status
YŏnginSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.