Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria.
NCT ID: NCT06670014
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
92 participants
INTERVENTIONAL
2024-11-20
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
* Treatment group: Participants in the treatment group will use the \'repeech\' application for 4 weeks, with recommended usage of 5 days per week, for 30 to 60 minutes per session.
* Control Group: Participants in the control group will use a workbook provided by the sponsor, due the lack of a standarized care protocol for dysarthria. The control group will be instructed to use the workbook with the same frequency and duration as the treatment group (5 days per week, 30 to 60 minutes per session).
TREATMENT
SINGLE
Study Groups
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'repeech' Intervention Group
Participants in this group will use the 'repeech' for treatment.
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.
Control Group
Participants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Participants must be neurologically stable post-stroke, as determined by a qualified physician.
3. Participants must have dysarthria due to stroke, with a National Institutes of Health 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 to understand and follow the assessment procedures, as determined by the Principal Investigator.
6. Participants must be able to use general-purpose digital equipment and comfortable with using the digital therapeutics(DTx) platform for this study.
7. Participants must provide informed consent after receiving a thorough explanation of the study, including potential risks and benefits. They must understand and agree to follow the study protocol.
Exclusion Criteria
2. Participants diagnosed with dementia, including Alzheimer's disease, Vascular dementia, 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 to study 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 the Prindipal Investigator(PI), would make their participation in the clinical trial unsuitable or pose siginficant risks.
9. Participants who decline to participate in the study.
19 Years
ALL
No
Sponsors
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HAII corp.ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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JinGwon Kim
Role: backup
Yungeyong Jang
Role: backup
TaeJin Song
Role: backup
HoGeol Woo
Role: backup
JunHo Shin
Role: backup
Other Identifiers
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RDKC00
Identifier Type: -
Identifier Source: org_study_id
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