The Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria

Официальное название

A Prospective, Randomized, Multi-Centered Clinical Trial to Investigate the Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Smartphone-based speech therapy
  Participants will be instructed to use the speech therapy app for 1 hour per day (5 days for 1 week) over a 4-week period.
• Другое Home-based speech therapy
  Participants will receive treatment maintaining the same frequency as the intervention group.

Первичные конечные точки

• Speech intelligibility [Срок оценки: Baseline, 4 weeks]

Вторичные конечные точки (3)

• Maximum phonation Time (MPT) [Срок оценки: Baseline, 4 weeks]
• Oral-diadochokinesis (DDK) [Срок оценки: Baseline, 4 weeks]
• Percentage of Consonants Correct (PCC, %) [Срок оценки: Baseline, 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05877950 · SEUMC 2023-02-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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