A Prospective, Randomized, Multi-Centered Clinical Trial to Investigate the Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Speech intelligibility
研究概览
简要总结
This clinical trial aims to determine if a new smartphone-based speech therapy is effective self-treatment method for patients with post-stroke dysarthria. For this study, participants in the intervention group will use the speech therapy app for 1 hour per day, 5 days per week, over a 4-week period. The active control group will receive home-based speech therapy with the same duration and frequency as the intervention group.
The study will help us understand if smartphone-based speech therapy is a viable treatment option for post-stroke dysarthria patients.
详细描述
In this study, 100 patients with post-stroke dysarthria will be recruited and stratified into acute-subacute (within 1 month after index stroke) and chronic (after 6 months after index stroke) groups. Participants will then be randomly assigned to either the intervention or active control group.
Patients in the intervention group will use a smartphone-based speech therapy app that includes oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercises. Treatment goals and contents will be determined based on individual patient conditions by a speech-language pathologist after the baseline evaluation. Participants will receive daily sessions for 1 hour per day, 5 days per week, over a 4-week period.
Patients in the active control group will receive home-based speech therapy, which includes oro-motor exercises and reading tasks from a workbook, for the same frequency as the intervention group. Both groups will also receive usual stroke care.
The study aims to evaluate the efficacy of mobile-based speech therapy compared to home-based speech therapy in improving speech intelligibility scores 4 weeks after baseline for patients with dysarthria in the acute-subacute and chronic phases following stroke.
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)
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
- •Aged 18 or over.
- •Neurologically stable stroke patients diagnosed by a stroke specialist neurologist.
- •Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
- •First-ever stroke patients without previous stroke history.
- •Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26)
- •As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study
- •Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions.
排除标准
- •Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist.
- •Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
- •Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).
- •Patients taking concomitant medications that could affect the trial results during the study period (e.g., cognitive dysfunction medications, anticholinergics, anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, and hypnotics).
- •Patients unable to use/access smartphone technology.
- •Illiterate patients.
- •Patients unable to communicate in Korean.
- •Is unsuitable for participation due to other reasons, as determined by the investigator.
- •Has refused to participate in the study.
结局指标
主要结局
Speech intelligibility
时间窗: Baseline, 4 weeks
The change in speech intelligibility from baseline to 4 weeks post-intervention will be assessed. Speech intelligibility will be evaluated by having three naive listeners transcribe the participants' recorded speech. These transcriptions will then be compared to the original sentences to calculate a percentage score representing intelligibility. The final intelligibility score will be calculated as the average of the scores from the three naive listeners. A higher percentage indicates greater speech intelligibility.
次要结局
- Percentage of Consonants Correct (PCC, %)(Baseline, 4 weeks)
- Maximum phonation Time (MPT)(Baseline, 4 weeks)
- Oral-diadochokinesis (DDK)(Baseline, 4 weeks)
研究者
Tae-Jin Song, MD, PhD
Principal Investigator
Ewha Womans University Seoul Hospital