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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 9
- 主要终点
- Speech Intelligibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 19 years of age or older.
- •Participants must be neurologically stable after stroke, as determined by a qualified physician.
- •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).
- •Participants must have a Korean Mini-Mental State Examination (K-MMSE) score of 26 or higher within 1 month before study entry.
- •Participants must have sufficient vision, hearing, and motor function to complete the study procedures.
- •Participants must be able to use a tablet PC without difficulty.
- •Participants must provide voluntary written informed consent.
排除标准
- •Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment.
- •Participants diagnosed with dementia or who used medication for dementia within 3 months before screening.
- •Participants who are illiterate.
- •Participants with severe psychiatric illness, such as major depression, schizophrenia, or drug dependence.
- •Participants with severe language impairment that would prevent use of the digital application.
- •Participants with any other clinical reason that, in the investigator's judgment, would make participation unsuitable.
研究组 & 干预措施
Control Group
Participants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria.
干预措施: Workbook (Other)
'repeech' Intervention Group
Participants in this group will use the 'repeech' for treatment.
干预措施: repeech (Device)
结局指标
主要结局
Speech Intelligibility
时间窗: 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.
次要结局
- 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))
- Maximum Phonation Time (MPT)(Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up))
- Diadochokinetic Rate (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 of Dysarthric Speakers (QoL-Dys)(Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up))
- Treatment Adherence(4 weeks (post-treatment))