Completed

NCT Number: NCT06670014

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

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.

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Key information

Conditions

Post-stroke Dysarthria

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yongin Severance Hospital, Yongin, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment.
Participants diagnosed with dementia or who used medication for dementia within 3 months before screening.
Participants who are illiterate.
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.
Participants with any other clinical reason that, in the investigator's judgment, would make participation unsuitable.

Treatment and study plan

repeech

Device

Participants in this group will use the repeech application for a period of 4 weeks, with recommended usage of 5 days per week for 30 to 60 minutes per session. A designated speech-language pathologist (SLP) will set individualized treatment goals and customize the content of the therapy sessions based on each participant's baseline assessment. The repeech intervention will be tailored to meet the specific needs of each participant to improve speech intelligibility and communication abilities.

Workbook

Other

Participants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria, due to the lack of a standardized care protocol for this condition. The recommended usage is the same as the treatment group: 5 days per week, for 30 to 60 minutes per session over a period of 4 weeks. After each self-treatment session, participants will record their activities on a checklist to monitor adherence and ensure compliance with the study protocol.

Primary outcomes

Speech Intelligibility

Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)

Speech intelligibility refers to how well a listener can understand the participant's speech. Participants will read a standardized Korean passage developed to assess speech intelligibility. Speech samples will be evaluated by three blinded speech-language pathologists (SLPs), who will independently assess intelligibility using a scale from 0 to 100, where 0 represents completely unintelligible speech and 100 represents fully intelligible speech. The average score from the three evaluations will be used for analysis. The primary outcome is the change in speech intelligibility from baseline to 4 weeks.

Secondary outcomes

Maximum Phonation Time (MPT)

Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)

Maximum Phonation Time (MPT) refers to the longest duration for which a participant can sustain the vowel /a/ after a deep inhalation. The task is performed twice, and the longest duration is recorded in seconds.
Diadochokinetic Rate (DDK)

Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)

Diadochokinetic rate (DDK) measures the speed and accuracy of repetitive speech movements. Participants repeat /pa/, /ta/, /ka/, and /pataka/ as quickly and accurately as possible. The number of correctly repeated syllables or syllable sequences per second is recorded.
Percentage of Consonants Correct (PCC)

Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)

Percentage of Consonants Correct (PCC) assesses consonant articulation accuracy during a standardized 30-word reading task. Accuracy is calculated as the percentage of correctly produced consonants out of the total intended consonants.
Patient Health Questionnaire-9 (PHQ-9)

Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)

The PHQ-9 is a self-administered questionnaire used to assess depressive symptoms. It consists of 9 items, with higher scores indicating more severe depressive symptoms. Participants complete the PHQ-9 through the study application.
Quality of Life of Dysarthric Speakers (QoL-Dys)

Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)

The QoL-Dys is a self-reported questionnaire used to assess disease-specific quality of life in individuals with dysarthria. It evaluates the impact of dysarthria-related communication difficulties on daily life. Participants complete the Korean version of the QoL-Dys through the study application.
Treatment Adherence

Time frame: 4 weeks (post-treatment)

Treatment adherence is defined as the number of completed sessions divided by the 20 prescribed sessions, expressed as a percentage. In the treatment group, completed sessions are recorded through application logs. In the control group, completed sessions are recorded through workbook checklists reviewed by study staff.

Other outcomes

System Usability Scale (SUS)

Time frame: 4 weeks (post-treatment)

The System Usability Scale (SUS) is a 10-item questionnaire used to assess the perceived usability of the digital speech therapy application. SUS is assessed only in the treatment group at 4 weeks, with higher scores indicating better perceived usability.

Sponsors and collaborators

Lead sponsor

HAII corp.ltd

Industry

Registry information

Official study title

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.

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 1, 2024
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.