Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke; Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Speech intelligibility
Study Overview
Brief Summary
This pilot trial will establish the feasibility of a new digitized speech rehabilitation developed for patients with post-stroke dysarthria. For this study, participants will be instructed to use the speech therapy app for 30 minutes to 1 hour per day over a 4-week period.
Detailed Description
A total of 40 patients with post-stroke dysarthria will be recruited and randomly divided into intervention and control groups.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Outcome Assessor
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Neurologically stable, as determined by the clinician.
- •Onset of stroke within four weeks prior to randomization.
- •Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
- •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.
- •Capable of walking or moving alone or with the assistance of a walking aid (e.g., walkers, canes, or wheelchairs).
- •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
- •Unable to measure articulatory or orofacial functions due to organic causes/lesions in articulatory and cervical structure.
- •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.
- •Has a Mini-Mental State Exam score of 26 or below at the time of screening.
- •Has a Clinical Dementia Rating score of 1 ≥ or a Global Deterioration Scale score of 3 ≥ at the time of screening.
- •Received dementia treatment within 3 months of screening.
- •Takes medication that may impact cognitive function during the clinical trial period.
- •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).
- •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.
- •Is uneducated or illiterate.
- •Has been diagnosed with a serious mental illness such as severe depression, schizophrenia, alcohol addiction, or drug addiction.
- •Unable to use D-ST01 due to severe speech impairment, as determined by the clinician.
Outcomes
Primary Outcomes
Speech intelligibility
Time Frame: Baseline, 4weeks
Speech intelligibility is evaluated with a score of 0 (normal), 1 (intelligible, some differences noticeable), 2 (intelligible, noticeably different), 3 (intelligible with careful listening, some unintelligible), 4 (difficult to understand, many words unintelligible), 5 (usually unintelligible), or 6 (unintelligible).
Secondary Outcomes
- The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2)(Baseline, 4weeks)
Investigators
Tae-Jin Song, MD, PhD
Principal investigator, Department of neurology, Seoul Hospital, Ewha Womans University College of Medicine
Ewha Womans University Seoul Hospital