Post-stroke Dysarthria
Conditions
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.
Interventions
DEVICErepeech
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.
OTHERWorkbook
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.
Sponsors
HAII corp.ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study includes three blinded speech-language pathologists (SLPs) who will evaluate speech intelligibility, the primary outcome measure. These SLPs will be blinded to the group assignments (treatment or control) of the participants. Each SLP will independently assess the speech intelligibility of participants at three time points: baseline, post-treatment, and follow-up.
Intervention model description
This is a two-arm, randomized, parallel-group, assessor-blinded, multicenter, non-inferiority interventional study comparing digital speech therapy using the repeech application with workbook-based home treatment in participants with post-stroke dysarthria. * Intervention group: Participants assigned to the experimental group will use the repeech application for 4 weeks. They will be instructed to practice for 30 to 60 minutes per day, 5 days per week. * Control group: Participants assigned to the active comparator group will receive workbook-based home treatment consisting of conventional behavioral speech-therapy exercises. They will be instructed to practice with the same frequency and duration as the experimental group: 30 to 60 minutes per day, 5 days per week, for 4 weeks.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must be 19 years of age or older. 2. Participants must be neurologically stable after stroke, as determined by a qualified physician. 3. Participants must have objective post-stroke dysarthria, defined as a score of 1 or 2 on the dysarthria item of the National Institutes of Health Stroke Scale (NIHSS). 4. Participants must have a Korean Mini-Mental State Examination (K-MMSE) score of 26 or higher within 1 month before study entry. 5. Participants must have sufficient vision, hearing, and motor function to complete the study procedures. 6. Participants must be able to use a tablet PC without difficulty. 7. Participants must provide voluntary written informed consent.
Exclusion criteria
1. Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment. 2. Participants diagnosed with dementia or who used medication for dementia within 3 months before screening. 3. Participants who are illiterate. 4. Participants with severe psychiatric illness, such as major depression, schizophrenia, or drug dependence. 5. Participants with severe language impairment that would prevent use of the digital application. 6. Participants with any other clinical reason that, in the investigator's judgment, would make participation unsuitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility | 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 a standardized Korean passage developed to assess speech intelligibility. Speech samples will be evaluated by three blinded speech-language pathologists (SLPs), who will independently assess intelligibility using a scale from 0 to 100, where 0 represents completely unintelligible speech and 100 represents fully intelligible speech. The average score from the three evaluations will be used for analysis. The primary outcome is the change in speech intelligibility from baseline to 4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Phonation Time (MPT) | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) | Maximum Phonation Time (MPT) refers to the longest duration for which a participant can sustain the vowel /a/ after a deep inhalation. The task is performed twice, and the longest duration is recorded in seconds. |
| Diadochokinetic Rate (DDK) | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) | Diadochokinetic rate (DDK) measures the speed and accuracy of repetitive speech movements. Participants repeat /pa/, /ta/, /ka/, and /pataka/ as quickly and accurately as possible. The number of correctly repeated syllables or syllable sequences per second is recorded. |
| Percentage of Consonants Correct (PCC) | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) | Percentage of Consonants Correct (PCC) assesses consonant articulation accuracy during a standardized 30-word reading task. Accuracy is calculated as the percentage of correctly produced consonants out of the total intended consonants. |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) | The PHQ-9 is a self-administered questionnaire used to assess depressive symptoms. It consists of 9 items, with higher scores indicating more severe depressive symptoms. Participants complete the PHQ-9 through the study application. |
| Quality of Life of Dysarthric Speakers (QoL-Dys) | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) | The QoL-Dys is a self-reported questionnaire used to assess disease-specific quality of life in individuals with dysarthria. It evaluates the impact of dysarthria-related communication difficulties on daily life. Participants complete the Korean version of the QoL-Dys through the study application. |
| Treatment Adherence | 4 weeks (post-treatment) | Treatment adherence is defined as the number of completed sessions divided by the 20 prescribed sessions, expressed as a percentage. In the treatment group, completed sessions are recorded through application logs. In the control group, completed sessions are recorded through workbook checklists reviewed by study staff. |
Countries
South Korea
Outcome results
None listed