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

NCT ID: NCT05865106

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-05-20

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.

Detailed Description

A total of 76 patients with post-stroke dysarthria will be recruited and stratified by the onset period into acute-subacute (within 6month after index stroke) and chronic (after 6 months after index stroke). Then participants are randomly divided into intervention and control groups.

Patients in the intervention group will be instructed to use smartphone-based speech therapy applications, including oro-motor exercise, phonation, articulation, resonance, syllable repetition, and reading exercises. After the baseline evaluation, treatment goals, and contents will be determined with a speech-language pathologist according to the condition of individual patients. Daily sessions will be provided for 1 hour per day, 5 days per week, over a 4-week period.

Patients in the control group will be instructed to receive traditional speech therapy. Traditional speech therapy can include face-to-face speech therapy, including oro-motor exercises, reading aloud slowly and clearly, and practicing proper breathing and sustained speech. To maintain the same dose and frequency as the intervention group, 60 minutes of treatment will be performed five days a week (e.g., two days of face-to-face speech therapy per week (60 minutes) + three days of self-training through the reading task workbook (60 minutes).

The aim of the study is to establish smartphone-based speech therapy is non-inferior to traditional speech therapy for improving speech intelligibility.

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

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.

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.

Traditional speech therapy

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.

Group Type: OTHER

Traditional 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

Traditional 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

Locations

Ewha Womans University Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 38356882 (View on PubMed)

Other Identifiers

SEUMC 2023-02-002

Identifier Type: -

Identifier Source: org_study_id