Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke; Pilot Trial

Conditions
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Dysarthria as Late Effect of Stroke

Intervention / Treatment
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* Device: Mobile application
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group will receive treatment as usual along with the speech therapy app. | Device: Mobile application<br>* 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.<br>Other: Treatment as usual<br>* The patients will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.<br>|
| No Intervention: Control<br>The control group will receive treatment as usual only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility | 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). | Baseline, 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2) | he UTAP2, an essential tool for determining articulatory proficiency, will be employed to evaluate the Percentage of Consonants Correct (PCC), a crucial metric for identifying irregularities in articulation. Study participants will be instructed to read all 30 words from the UTAP2 word-level test. Following this, evaluators will calculate the PCC, expressed as a percentage, using the 94 consonants included in these words. This methodology acknowledges that a PCC of 0% signifies lower articulatory accuracy, whereas a PCC of 100% reflects a higher level of precision. | Baseline, 4weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysarthria, Stroke, digital therapeutics, Speech Disorders, Language Disorders, speech rehabilitation, application, Post-stroke dysarthria