The Efficacy and Feasibility of Smartphone-Based Speech Therapy for People with Post-Stroke Dysarthria

NCT05865106 | Completed

• 1 other identifier: SEUMC 2023-02-002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to determine if a new smartphone-based speech therapy is effective and feasible for patients with post-stroke dysarthria. 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 control group will receive the same duration and frequency of traditional speech therapy 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 (4)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 4 weeks

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

  Baseline, 4 weeks

• System Usability Questionnaire (SUS)

  4 weeks

Study Arms (2)

Smartphone-based speech therapy

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.

Device: Smartphone-based speech therapy

Traditional speech therapy

OTHER

Traditional speech therapy: Traditional speech therapy methods, such as face-to-face sessions, oro-motor exercises for the tongue, lips, chin, and jaw, reading aloud slowly and clearly, and practicing proper breathing and sustained speech, will be employed.

Other: Traditional 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

Traditional speech therapy OTHER

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

Traditional speech therapy

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

Study Sites (1)

Ewha Womans University Medical Center

Seoul, Seoul, 07804, South Korea

Location

Related Publications (1)

• Kim Y, Kim M, Kim J, Song TJ. Efficacy and feasibility of a digital speech therapy for post-stroke dysarthria: protocol for a randomized controlled trial. Front Neurol. 2024 Jan 31;15:1305297. doi: 10.3389/fneur.2024.1305297. eCollection 2024.

  PMID: 38356882 DERIVED

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 18, 2023
• Study Start: June 1, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)