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

NCT06670014 | Not Yet Recruiting

• 1 other identifier: RDKC00
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Post-stroke Dysarthria

Outcome Measures

Primary Outcomes (1)

• Speech Intelligibility

  Speech intelligibility refers to how well a listener can understand the participant's speech. Participants will read sentences specifically developed to assess speech intelligibility. The speech samples will be evaluated by three blinded speech-language pathologists (SLPs), who will independently assess the intelligibility of each participants speech using a scale of 0 to 100, where 0 represents completely unintelligible and 100 represents perfect intelligibility. The average score from the three evaluations will be used for analysis.

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

Secondary Outcomes (6)

• Maximum Phonation Time (MPT)

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

• Diadochokinesis Test, DDK

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

• Percentage of consonants correct, PCC

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

• Patient Health Questionnaire--9, PHQ-9

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

• Quality of life in the dysarthric speaker, QoL-DyS

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

Study Arms (2)

'repeech' Intervention Group

EXPERIMENTAL

Participants in this group will use the 'repeech' for treatment.

Device: repeech

Control Group

OTHER

Participants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria.

Other: Workbook

Interventions

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.

'repeech' Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 19 years of age or older.
• Participants must be neurologically stable post-stroke, as determined by a qualified physician.
• Participants must have dysarthria due to stroke, with a National Institutes of Health Stroke Scale (NIHSS) score 1 (mild) or 2 (moderate) for dysarthria.
• 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.
• Participants must have sufficient visual, auditory, langauge, and motor abilities to understand and follow the assessment procedures, as determined by the Principal Investigator.
• Participants must be able to use general-purpose digital equipment and comfortable with using the digital therapeutics(DTx) platform for this study.
• 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.

You may not qualify if:

• Participants with sigificant structural problems affecting the oral cavity and cervial region that would hinder accurate assessment.
• 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.
• Participants currently receiving treatment for dementia within 3 months prior to study screening.
• Participants who are unable to read or write in the language of the study.
• Participants with severe mental health conditions including severe depression, schizophrenia, alcohol addicsion, drug dependence.
• Participants with a severe langauge disorder, as determined by the physician(MD), that would significantly hinder their abiity to use digital therapeutics platform.
• Participants deemed by the MD as unable to use general-purpose digital equipment.
• 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.
• Participants who decline to participate in the study.

Sponsors & Collaborators

• HAII corp.ltd: lead

Study Sites (5)

Yongin Severance Hospital

Yongin, Gyeonggi-do, South Korea

Location

Ewha Womans University Mokdong Medical Center

Seoul, South Korea

Location

Ewha Womans University Seoul Medical Center

Seoul, South Korea

Location

KyunHee University Hospital

Seoul, South Korea

Location

National Rehabilitation Center

Seoul, South Korea

Location

Central Study Contacts

Rachel Lee

CONTACT

+82 10-7390-5023; rachel.lee@haii.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study includes three blinded speech-language pathologists (SLPs) who will evaluate the speech intelligibility, the primary outcome measure. These SLPs will be blinded to the group assignments (treatment or control) of the participants. Each SLP will independentlry assess the speech intelligibility of participants at three times points: baseline, post-treatment, and follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a two-arm interventional study comparing the efficacy of \'repeech\' application to a workbook-based treatment for post-stroke dyasarthria. * 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).

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 1, 2024
• Study Start: November 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

KR (5)