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Not yet recruiting NCT05877950

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

No phase Interventional Dysarthria As Late Effect of Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone-based speech therapy, Home-based speech therapy.
Who it may be relevant to
Registry conditions: Dysarthria As Late Effect of Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective, Randomized, Multi-Centered Clinical Trial to Investigate the Effectiveness of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria

Overview

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.

Detailed 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.

Interventions

  • Device Smartphone-based speech therapy
    Participants will be instructed to use the speech therapy app for 1 hour per day (5 days for 1 week) over a 4-week period.
  • Other Home-based speech therapy
    Participants will receive treatment maintaining the same frequency as the intervention group.

Primary outcome measures

  • Speech intelligibility [Time frame: Baseline, 4 weeks]
Secondary outcome measures (3)
  • Maximum phonation Time (MPT) [Time frame: Baseline, 4 weeks]
  • Oral-diadochokinesis (DDK) [Time frame: Baseline, 4 weeks]
  • Percentage of Consonants Correct (PCC, %) [Time frame: Baseline, 4 weeks]

Eligibility criteria

Inclusion criteria

  • Aged 18 or over.
  • Neurologically stable stroke patients diagnosed by a stroke specialist neurologist.
  • Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
  • First-ever stroke patients without previous stroke history.
  • Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26)
  • As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study
  • Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions.

Exclusion criteria

  • Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist.
  • Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
  • Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).
  • Patients taking concomitant medications that could affect the trial results during the study period (e.g., cognitive dysfunction medications, anticholinergics, anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, and hypnotics).
  • Patients unable to use/access smartphone technology.
  • Illiterate patients.
  • Patients unable to communicate in Korean.
  • Is unsuitable for participation due to other reasons, as determined by the investigator.
  • Has refused to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05877950 · SEUMC 2023-02-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗