Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A total of 60 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention The intervention group will receive treatment as usual along with the speech therapy app. |
Device: 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.
Other: Treatment as usual
The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
|
| No Intervention: Control The control group will receive treatment as usual only. |
Outcome Measures
Primary Outcome Measures
- Speech intelligibility [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 Outcome Measures
- The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2) [Baseline, 4weeks]
The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2)
- Change in the speech mechanism test [Baseline, 4weeks]
Change in the speech mechanism test [ Time Frame: Baseline, 4weeks ] Speech mechanism screening tests will be used to measure the degree of dysarthria. The test consists of three categories; 1)evaluating the structure and function of the articulators, 2)phonation and articulation accuracy, and 3) articulation regularity and accuracy in the alternate motion rates and sequential motion rates.
Other Outcome Measures
- National Institute of Health Stroke Scale (NIHSS) [Baseline, 4weeks]
NIHSS will be used to assess stroke-related neurologic deficits. The NIHSS scale is made up of 11 different elements that evaluate specific abilities; level of consciousness (LOC), best gaze, visual field, facial palsy, motor arm, motor leg, limb ataxia, sensory, best language, dysarthria, extinction, inattention. The score ranges from 0 to 42; higher scores indicate more severe stroke symptoms.
- Patient Health Questionnaire-9 (PHQ-9) [Baseline, 4weeks]
The PHQ-9 is a nine-item self-reported questionnaire that is used to assess depressive symptoms. The score ranges from 0 to 27, with lower scores indicating less depressive severity.
- Generalized Anxiety disorder-7 [Baseline, 4weeks]
GAD-7(Generalized Anxiety disorder-7) will be used to assess anxiety. The GAD-7(Generalized Anxiety disorder-7) is a seven-item self-reported questionnaire that evaluates anxiety symptoms. The score ranges from 0 to 21, with lower scores indicating lower anxiety symptoms.
- Euro Quality of Life (EQ-5D) [Baseline, 4weeks]
EQ-5D will be used to assess the quality of life. The EQ-5D is a self-report questionnaire that measures health-related quality of life. The questionnaire consists of five dimensions: mobility, self-care, ordinary activities, discomfort, and mood state related to anxiety or depression. The responses indicate three levels of severity ("no problems", "some problems", and "extreme problems") within each EQ-5D dimension.
- Modified Computer Self-Efficacy Scale (mCSES) [Baseline, 4weeks]
mCSES will be used to assess participants' perceptions of self-efficacy with respect to using a computerized system. The mCSES is a 10-item self-reported questionnaire. The score ranges from 0 to 100; higher scores indicate a stronger sense of personal competence.
Eligibility Criteria
Criteria
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 21 ≥ 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 20 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ewha Womans University Medical Center | Seoul | Korea, Republic of | 07804 |
Sponsors and Collaborators
- Ewha Womans University Seoul Hospital
Investigators
- Principal Investigator: Tae-Jin Song, MD, PhD, Department of Neurology, Ewha University College of Medicine, Seoul, Republic of Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D-ST01