Purpose

This study evaluates the efficacy of smartphone-based speech therapy administered at home compared with usual care. Participants will be randomized into the treatment and waitlist control groups with an allocation ratio of 1:1.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must be able to use a smartphone-based speech therapy application, as determined by self-reporting cognitive abilities. - Speaks English as a native language.

Exclusion Criteria

  • Unable to use smartphone application or conduct speech assessment due to severe speech impairment. - Self-reported co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism). - Patient with severe mental disorders as self-reported (e.g., depression, schizophrenia, alcohol addiction, or drug addiction). - Illiterate patients.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
This is a single-center, investigator-blinded, randomized, crossover effectiveness study. After recruitment, the participants will be randomly assigned to one of two groups: Group 1 will first receive smartphone-based speech therapy and then usual care as a control, whereas Group 2 will be on waitlist control first and then receive speech therapy. In this study, both the objective and subjective measurements will be performed three times: at baseline, post-phase 1 study (week 4), and post-phase 2 study (week 8). The study includes three intervention cycles, and for each research cycle, 12 subjects will be recruited to participate (6 per each group × 3 cycles).
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Due to the interactive nature of rehabilitation, masking the intervention to patients and research investigators is impossible. Therefore, separate outcome assessors will be blinded, who will not be involved in the treatment procedures, to minimize bias.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention
Participants in the intervention group will use a speech therapy application, a software designed for post-stroke dysarthria speech therapy and provided in the form of a mobile application. The application provides intensive speech treatment, including respiration, phonation, resonance, prosody, and articulation exercises. The system analyzes patients' voices collected while using the application and delivers the results through real-time visual and summary feedback, increasing patients' ability to self-monitor.
  • Behavioral: Smart-phone based, self-driven speech rehabilitation
    Participants will perform the speech exercises for 60 min per day. Participants may complete the speech exercises all at once or split them into several sessions. Thus, participants assigned to the intervention group will use the application for 30-60 min daily, 5 days per week, for 4 consecutive weeks.
No Intervention
Waitlist control

Recruiting Locations

Florida State University
Tallahassee 4174715, Florida 4155751 32309
Contact:
Yunjung Kim, PhD
850 645 4804
ykim19@fsu.edu

More Details

NCT ID
NCT06592183
Status
Recruiting
Sponsor
Florida State University

Study Contact

Yunjung Kim
8506454804
ykim19@fsu.edu

Detailed Description

Despite the importance of dysarthria intervention in post-stroke rehabilitation, further research in this area remains underexplored. This study builds on previous research on the use of smartphone-based dysarthria interventions based on motor learning principles, such as repetitive training and feedback and neuroplasticity through repetition, motivation, and reward. The treatment duration of 1h, 5 times a week for 4 weeks, is consistent with previous behavioral interventions for post-stroke dysarthria. This study aimed to determine whether the condition of patients with stroke can be improved through the use of smartphone-based interventions. This is a single-center, investigator-blinded, randomized, crossover effectiveness study. In this study, both the objective and subjective measurements will be performed three times: at baseline, post-phase 1 study (week 4), and post-phase 2 study (week 8). The study includes three intervention cycles, and for each research cycle, 12 subjects will be recruited to participate (6 per each group × 3 cycles).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.