NCT05865106Completed
The Efficacy and Feasibility of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
A Prospective, Randomized, Multi-Center Pilot Trial to Evaluate the Efficacy and Feasibility of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria
Source: ClinicalTrials.gov · Last updated 30 Aug 2024
Brief summary (registry, in English)
This clinical trial aims to determine if a new smartphone-based speech therapy is effective and feasible for patients with post-stroke dysarthria. 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 control group will receive the same duration and frequency of traditional speech therapy 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 8 May 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 20 May 2024
- Lead sponsor
- Ewha Womans University Seoul Hospital
- Diseases
- Stroke
- NCT number
- NCT05865106
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 1 Jun 2023 to the primary completion date, 20 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ewha Womans University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.