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

NCT ID: NCT05877950

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Dysarthria As Late Effect of Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Smartphone-based speech therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Home-based speech therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Home-based speech therapy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role: collaborator

National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role: collaborator

Ewha Womans University Seoul Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tae-Jin Song, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ewha Womans University Medical Center

Role: CONTACT

knstar@hanmail.net

+82-2-6986-3307

Other Identifiers

SEUMC 2023-02-003

Identifier Type: -

Identifier Source: org_study_id