Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke

Not Applicable

Completed

• Conditions: Dysarthria as Late Effect of Stroke
• Interventions: Device: Mobile application; Other: Treatment as usual

• Registration Number: NCT05146765
• Lead Sponsor: Ewha Womans University Seoul Hospital

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 Timeline

• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-07
• Study Start: 2022-01-18
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Mobile application	The intervention group will receive treatment as usual along with the speech therapy app.
Intervention	Treatment as usual	The intervention group will receive treatment as usual along with the speech therapy app.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The percent change in score on the Urimal Test of Articulation and Phonology 2 (UTAP2)	Baseline, 4weeks	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.

Trial Locations

Locations (1)

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of