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

NCT05877950 | Not Yet Recruiting

• 1 other identifier: SEUMC 2023-02-003
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dysarthria As Late Effect of Stroke

Outcome Measures

Primary Outcomes (1)

• Speech intelligibility

  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 Outcomes (3)

• Maximum phonation Time (MPT)

  Baseline, 4 weeks

• Oral-diadochokinesis (DDK)

  Baseline, 4 weeks

• Percentage of Consonants Correct (PCC, %)

  Baseline, 4 weeks

Other Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 4 weeks

• Quality of Life in the Dysarthric Speaker (QOL-Dys)

  Baseline, 4 weeks

• Communicative Effectiveness Survey (CES)

  Baseline, 4 weeks

Study Arms (2)

Smartphone-based speech therapy with usual stroke care

EXPERIMENTAL

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

Home-based speech therapy with usual stroke care

ACTIVE COMPARATOR

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

Interventions

Smartphone-based speech therapy DEVICE

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.

Smartphone-based speech therapy with usual stroke care

Home-based speech therapy OTHER

Participants will receive treatment maintaining the same frequency as the intervention group.

Home-based speech therapy with usual stroke care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ewha Womans University Seoul Hospital: lead
• Ewha Womans University Mokdong Hospital: collaborator
• National Rehabilitation Center, Seoul, Korea: collaborator

Central Study Contacts

Ewha Womans University Medical Center

CONTACT

+82-2-6986-3307; knstar@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 26, 2023
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share