Clinical trial NCT05146765: Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke
Official title: Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke; Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysarthria as Late Effect of Stroke
Keywords: Dysarthria
Stroke
digital therapeutics
Speech Disorders
Language Disorders
speech rehabilitation
application
Post-stroke dysarthria
Lead sponsor: Ewha Womans University Seoul Hospital
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Neurologically stable, as determined by the clinician.
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:

1. Unable to measure articulatory or orofacial functions due to organic causes/lesions in articulatory and cervical structure.
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.

Primary outcomes:
measure: Speech intelligibility
timeFrame: Baseline, 4weeks
Secondary outcomes:
measure: The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2)
timeFrame: Baseline, 4weeks
Other outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: Baseline, 4weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 4weeks
measure: Generalized Anxiety disorder-7
timeFrame: Baseline, 4weeks
measure: Euro Quality of Life (EQ-5D)
timeFrame: Baseline, 4weeks
measure: Modified Computer Self-Efficacy Scale (mCSES)
timeFrame: Baseline, 4weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
Study officials:
affiliation: Department of Neurology, Ewha University College of Medicine, Seoul, Republic of Korea
name: Tae-Jin Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: