The Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria

Last updated: August 28, 2024
Sponsor: Ewha Womans University Seoul Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Speech Disorders

Treatment

Home-based speech therapy

Smartphone-based speech therapy

Clinical Study ID

NCT05877950
SEUMC 2023-02-003
  • Ages > 18
  • All Genders

Study Summary

This clinical trial aims to determine if a new smartphone-based speech therapy is effective self-treatment method for patients with post-stroke dysarthria. For this study, participants in the intervention group will use the speech therapy app for 1 hour per day, 5 days per week, over a 4-week period. The active control group will receive home-based speech therapy with the same duration and frequency as the intervention group.

The study will help us understand if smartphone-based speech therapy is a viable treatment option for post-stroke dysarthria patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 or over.

  2. Neurologically stable stroke patients diagnosed by a stroke specialist neurologist.

  3. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialtyneurologist.

  4. First-ever stroke patients without previous stroke history.

  5. Patients with sufficient cognitive abilities to operate the smartphone-based speechtherapy application (Mini-Mental State Exam score ≥ 26)

  6. As judged by the neurology specialists: patients with sufficient vision, hearing,communication skills, and motor skills to participate in this study

  7. Must have voluntarily understood the trial and signed a consent form agreeing tocomply with precautions.

Exclusion

Exclusion Criteria:

  1. Co-existing language disorder (e.g., aphasia). Aphasia will be determined by astroke specialist.

  2. Co-existing progressive neurological disorders that can affect dysarthria (e.g.,dementia, Pick's disease, Huntington's disease, Parkinson's disease, orParkinsonism).

  3. Diagnosis of severe mental disorders as determined by a clinician (e.g., depression,schizophrenia, alcohol addiction, or drug addiction).

  4. Patients taking concomitant medications that could affect the trial results duringthe study period (e.g., cognitive dysfunction medications, anticholinergics,anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, andhypnotics).

  5. Patients unable to use/access smartphone technology.

  6. Illiterate patients.

  7. Patients unable to communicate in Korean.

  8. Is unsuitable for participation due to other reasons, as determined by theinvestigator.

  9. Has refused to participate in the study.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Home-based speech therapy
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

In this study, 100 patients with post-stroke dysarthria will be recruited and stratified into acute-subacute (within 1 month after index stroke) and chronic (after 6 months after index stroke) groups. Participants will then be randomly assigned to either the intervention or active control group.

Patients in the intervention group will use a smartphone-based speech therapy app that includes oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercises. Treatment goals and contents will be determined based on individual patient conditions by a speech-language pathologist after the baseline evaluation. Participants will receive daily sessions for 1 hour per day, 5 days per week, over a 4-week period.

Patients in the active control group will receive home-based speech therapy, which includes oro-motor exercises and reading tasks from a workbook, for the same frequency as the intervention group. Both groups will also receive usual stroke care.

The study aims to evaluate the efficacy of mobile-based speech therapy compared to home-based speech therapy in improving speech intelligibility scores 4 weeks after baseline for patients with dysarthria in the acute-subacute and chronic phases following stroke.