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

May 17, 2023 updated by: Tae-Jin Song, MD, PhD, Ewha Womans University Seoul Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 specialty neurologist.
  4. First-ever stroke patients without previous stroke history.
  5. Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy 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 to comply with precautions.

Exclusion Criteria:

  1. Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist.
  2. Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
  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 during the study period (e.g., cognitive dysfunction medications, anticholinergics, anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, and hypnotics).
  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 the investigator.
  9. Has refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartphone-based speech therapy with usual stroke care

Smartphone-based speech therapy: Participants will be instructed to use smartphone-based speech therapy (application), including oro-motor exercises, phonation, articulation, resonance, syllable repetition, and reading exercises.

Usual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
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.
Active Comparator: Home-based speech therapy with usual stroke care

Home-based speech therapy: Participants will receive treatment such as oro-motor exercises and reading tasks from a workbook.

Usual stroke care: Participants will follow the treatment as usual, including conventional stroke therapy if needed based on the medical guidelines.
Other: Home-based speech therapy
Participants will receive treatment maintaining the same frequency as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech intelligibility
Time Frame: Baseline, 4 weeks
The change in speech intelligibility from baseline to 4 weeks post-intervention will be assessed. Speech intelligibility will be evaluated by having three naive listeners transcribe the participants' recorded speech. These transcriptions will then be compared to the original sentences to calculate a percentage score representing intelligibility. The final intelligibility score will be calculated as the average of the scores from the three naive listeners. A higher percentage indicates greater speech intelligibility.
Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum phonation Time (MPT)
Time Frame: Baseline, 4 weeks
The change in maximum phonation time (MPT) from baseline to 4 weeks post-intervention will be assessed. MPT will be used to assess participants' maximum phonation time. The speech evaluator instructs the patient to take a comfortable breath and then produce the sound /a/ for as long as possible. The task is performed twice, and the maximum duration of the two measurements is used.
Baseline, 4 weeks
Oral-diadochokinesis (DDK)
Time Frame: Baseline, 4 weeks
The Oral-diadochokinesis (DDK) change from baseline to 4 weeks post-intervention will be assessed. DDK will be used to assess articulation rate, regularity, and accuracy. Participants are instructed to repeat the syllables /pa/, /ta/, /ka/, and /pataka/ as quickly and accurately as possible. The number of repetitions is divided by the duration of the task.
Baseline, 4 weeks
Percentage of Consonants Correct (PCC, %)
Time Frame: Baseline, 4 weeks
The Percentage of Consonants Correct (PCC, %) change from baseline to 4 weeks post-intervention will be assessed. PCC is evaluated as a percentage score calculated from the Urimal Test of Articulation and Phonology 2 (UTAP2).
Baseline, 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 4 weeks
PHQ-9 will be used to assess depression. The PHQ-9 is a nine-item self-reported questionnaire for the measurement of depressive symptoms during the last two weeks.
Baseline, 4 weeks
Quality of Life in the Dysarthric Speaker (QOL-Dys)
Time Frame: Baseline, 4 weeks
QOL-Dys will be used to assess the comprehensive quality of life of individuals with dysarthria. The questionnaire consists of four dimensions: characteristics of speech, situational difficulties, use of compensation strategies, and perception of others. The responses are rated on a 5-point scale from 0 to 4, indicating the extent to which participants agree with each statement.
Baseline, 4 weeks
Communicative Effectiveness Survey (CES)
Time Frame: Baseline, 4 weeks
CES will be used to assess the communication efficiency of individuals with dysarthria in daily situations. The rating scale consists of 8 items and uses a 7-category rating scale ranging from "1 = not effective at all" to "7 = extremely effective" for everyday speaking situations.
Baseline, 4 weeks
System Usability Questionnaire (SUS)
Time Frame: 4 weeks
SUS will be used to assess user's subjective views of a system's usability. SUS will only be used in the intervention group at the end of treatment.
4 weeks
Application usage logs
Time Frame: 4 weeks
The log data will be used to evaluate compliance and acoustic factors. During the 4-week experimental period, the application login time, daily task completion rate, and raw data (.wav) of patients' voices are stored on the server for analysis.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Seoul Hospital

Collaborators

Ewha Womans University Mokdong Hospital
National Rehabilitation Center, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEUMC 2023-02-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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