Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06670014
NA

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

Sponsor: HAII corp.ltd

View on ClinicalTrials.gov

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.

Official 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.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2024-11-20

Completion Date

2025-12-31

Last Updated

2024-11-01

Healthy Volunteers

No

Interventions

DEVICE

repeech

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.

OTHER

Workbook

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.

Locations (5)

Yongin Severance Hospital

Yongin, Gyeonggi-do, South Korea

Ewha Womans University Mokdong Medical Center

Seoul, South Korea

Ewha Womans University Seoul Medical Center

Seoul, South Korea

KyunHee University Hospital

Seoul, South Korea

National Rehabilitation Center

Seoul, South Korea