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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post-stroke Dysarthria
- Sponsor
- HAII corp.ltd
- Enrollment
- 92
- Locations
- 5
- Primary Endpoint
- Speech Intelligibility
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
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 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.
Secondary Outcomes
- 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))
- Compliance(4 weeks (post-treatment))