Clinical trial NCT06670014: Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria.
Official title: A Randomized, Parallel-Group, Assessor-Blind, Multi-Center, Non-Inferiority Pivotal Study to Evaluate the Efficacy and Safety of the Digital Therapeutics &#39;repeech&#39; for the Post-Stroke Dysarthria.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-stroke Dysarthria
Lead sponsor: HAII corp.ltd
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 92
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm interventional study comparing the efficacy of \&#39;repeech\&#39; application to a workbook-based treatment for post-stroke dyasarthria.

* Treatment group: Participants in the treatment group will use the \&#39;repeech\&#39; 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).
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to evaluate the efficacy and safety of a digital therapeutic (DTx) application, \&#39;repeech\&#39;, 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), \&#39;repeech\&#39;, designed to complement tradtional speech therapy by addressing challenges such as accessibility, frequency of sessions, and personalized feedback. The \&#39;repeech\&#39; 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 \&#39;repeech\&#39; 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\&#39;s effectiveness and usability.

Eligibility criteria: Inclusion Criteria:

1. Participants must be 19 years of age or older.
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:

1. Participants with sigificant structural problems affecting the oral cavity and cervial region that would hinder accurate assessment.
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.

Primary outcomes:
measure: Speech Intelligibility
timeFrame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Secondary outcomes:
measure: Maximum Phonation Time (MPT)
timeFrame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
measure: Diadochokinesis Test, DDK
timeFrame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
measure: Percentage of consonants correct, PCC
timeFrame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
measure: Patient Health Questionnaire--9, PHQ-9
timeFrame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
measure: Quality of life in the dysarthric speaker, QoL-DyS
timeFrame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
measure: Compliance
timeFrame: 4 weeks (post-treatment)
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: KyunHee University Hospital
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
References: