Effect of Speech Rehabilitation Based on Mobile Application for People With Dysarthria After Stroke: A Single-Center, Investigator-Blinded, Randomized, Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Speech intelligibility on a visual analogue scale (VAS)
研究概览
简要总结
This study evaluates the efficacy of smartphone-based speech therapy administered at home compared with usual care. Participants will be randomized into the treatment and waitlist control groups with an allocation ratio of 1:1.
详细描述
Despite the importance of dysarthria intervention in post-stroke rehabilitation, further research in this area remains underexplored. This study builds on previous research on the use of smartphone-based dysarthria interventions based on motor learning principles, such as repetitive training and feedback and neuroplasticity through repetition, motivation, and reward. The treatment duration of 1h, 5 times a week for 4 weeks, is consistent with previous behavioral interventions for post-stroke dysarthria. This study aimed to determine whether the condition of patients with stroke can be improved through the use of smartphone-based interventions. This is a single-center, investigator-blinded, randomized, crossover effectiveness study. In this study, both the objective and subjective measurements will be performed three times: at baseline, post-phase 1 study (week 4), and post-phase 2 study (week 8). The study includes three intervention cycles, and for each research cycle, 12 subjects will be recruited to participate (6 per each group × 3 cycles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the interactive nature of rehabilitation, masking the intervention to patients and research investigators is impossible. Therefore, separate outcome assessors will be blinded, who will not be involved in the treatment procedures, to minimize bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to use a smartphone-based speech therapy application, as determined by self-reporting cognitive abilities.
- •Speaks English as a native language.
排除标准
- •Unable to use smartphone application or conduct speech assessment due to severe speech impairment.
- •Self-reported co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
- •Patient with severe mental disorders as self-reported (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).
- •Illiterate patients.
结局指标
主要结局
Speech intelligibility on a visual analogue scale (VAS)
时间窗: Immediately after and 8 weeks after treatment
Speech intelligibility ratings are often estimated using a visual analogue scale . Listeners will be asked to rate the degree to which they are able to understand the speech samples using a horizontally oriented continuous scale with end points labeled, totally unintelligible and completely intelligible (0-100). The averaged score from the listeners will serve as the speech intelligibility score of the participants.
次要结局
- Dysarthria Impact Profile (DIP)(Immediately after and 8 weeks after treatment)
- Quality of Life in the Dysarthria Speaker(Immediately after and 8 weeks after treatment)
- Carer Communication Outcomes After Stroke (CaCOAST)(Immediately after and 8 weeks after treatment)
- Speaking Rate (syl/s)(Immediately after and 8 weeks after treatment)
- Acoustic vowel space (KHz)(Immediately after and 8 weeks after treatment)
研究者
Yunjung Kim
Principal Investigator
Florida State University