NCT06670014

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: HAII corp.ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Post-stroke Dysarthria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

5 sites across 1 country: South Korea