Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 'repeech' Intervention Group | Experimental | Participants in this group will use the 'repeech' for treatment. |
|
| Control Group | Other | Participants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility | 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. | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Phonation Time (MPT) | 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. | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) |
| Diadochokinetic Rate (DDK) |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale (SUS) | The System Usability Scale (SUS) is a 10-item questionnaire used to assess the perceived usability of the digital speech therapy application. SUS is assessed only in the treatment group at 4 weeks, with higher scores indicating better perceived usability. | 4 weeks (post-treatment) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital | Yongin | Gyeonggi-do | South Korea | |||
| Ewha Womans University Mokdong Medical Center |
Not provided
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.
Not provided
Not provided
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.
|
| 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. |
|
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. |
| Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) |
| Percentage of Consonants Correct (PCC) | 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. | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) |
| Patient Health Questionnaire-9 (PHQ-9) | 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. | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) |
| Quality of Life of Dysarthric Speakers (QoL-Dys) | 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. | Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up) |
| Treatment Adherence | 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. | 4 weeks (post-treatment) |
| Seoul |
| South Korea |
| Ewha Womans University Seoul Medical Center | Seoul | South Korea |
| KyungHee University Hospital | Seoul | South Korea |
| National Rehabilitation Center | Seoul | South Korea |