Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke
NCT ID: NCT05146765
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-01-18
2022-08-30
Brief Summary
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Detailed Description
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Patients in the intervention group will be instructed to receive speech treatments including oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercise (App on mobile devices). Daily sessions will be provided during a 4-week period. Both groups will also receive treatment as usual. The aim of the study is to investigate the efficacy of mobile-based speech therapy in patients with dysarthria in the acute phase following stroke.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
The intervention group will receive treatment as usual along with the speech therapy app.
Mobile application
Device: Use of mobile application Participants will be instructed to use the speech therapy app for 30 minutes to one hour per day over a 4-week period.
Treatment as usual
The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
Control
The control group will receive treatment as usual only.
No interventions assigned to this group
Interventions
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Mobile application
Device: Use of mobile application Participants will be instructed to use the speech therapy app for 30 minutes to one hour per day over a 4-week period.
Treatment as usual
The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
Eligibility Criteria
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Inclusion Criteria
2. Onset of stroke within four weeks prior to randomization.
3. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
4. Maintains enough cognitive function to use the speech therapy application without problems, as determined by a Mini-Mental State Exam score of 26 ≥ within 1 month prior to randomization.
5. Capable of walking or moving alone or with the assistance of a walking aid (e.g., walkers, canes, or wheelchairs).
6. Must have intact vision, hearing, communication skills, and motor skills, as well as comprehension sufficient to proceed with assessment, as judged by the clinician.
Exclusion Criteria
2. Has comorbid neurological conditions that, in the opinion of the investigator, could impair study participation, such as dementia (Alzheimer's disease, vascular dementia, Central Nervous System Infection \[e.g., Human Immunodeficiency Virus, syphilis\], Creutzfeld-Jacob disease, etc.), Pick's disease, Huntington's disease, or Parkinson's disease.
3. Has a Mini-Mental State Exam score of 26 or below at the time of screening.
4. Has a Clinical Dementia Rating score of 1 ≥ or a Global Deterioration Scale score of 3 ≥ at the time of screening.
5. Received dementia treatment within 3 months of screening.
6. Takes medication that may impact cognitive function during the clinical trial period.
7. Co-medication is prohibited during the entire trial period for the following medications: drugs for dementia treatment, Central Nervous System stimulants, anticholinergics, tricyclic antidepressants, typical antipsychotics, and sleeping pills (excluding rapid-acting sleeping pills).
8. Co-medication is permitted if continued use of the following medications has been at a stable dose for 2 months prior to randomization: atypical antipsychotics, anxiolytics, antidepressants (excluding tricyclic antidepressants), thyroid hormone, and rapid-acting sleeping pills.
9. Is uneducated or illiterate.
10. Has been diagnosed with a serious mental illness such as severe depression, schizophrenia, alcohol addiction, or drug addiction.
11. Unable to use D-ST01 due to severe speech impairment, as determined by the clinician.
ALL
No
Sponsors
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Ewha Womans University Seoul Hospital
OTHER
Responsible Party
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Tae-Jin Song, MD, PhD
Principal investigator, Department of neurology, Seoul Hospital, Ewha Womans University College of Medicine
Principal Investigators
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Tae-Jin Song, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Ewha University College of Medicine, Seoul, Republic of Korea
Locations
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Ewha Womans University Medical Center
Seoul, , South Korea
Countries
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References
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Kim Y, Kim M, Kim J, Song TJ. Smartphone-Based Speech Therapy for Poststroke Dysarthria: Pilot Randomized Controlled Trial Evaluating Efficacy and Feasibility. J Med Internet Res. 2024 Apr 25;26:e56417. doi: 10.2196/56417.
Other Identifiers
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D-ST01
Identifier Type: -
Identifier Source: org_study_id