Speech Rehabilitation Based on Mobile Applications

Effect of Speech Rehabilitation Based on Mobile Application for People With Dysarthria After Stroke: A Single-Center, Investigator-Blinded, Randomized, Crossover Trial

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Motor Speech Disorder
• Intervention / Treatment: Behavioral: Smart-phone based, self-driven speech rehabilitation

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).

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32309
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech intelligibility on a visual analogue scale (VAS)	Speech intelligibility ratings are often estimated using a visual analogue scale . Listeners will be asked to rate the degree to which they are able to understand the speech samples using a horizontally oriented continuous scale with end points labeled, totally unintelligible and completely intelligible (0-100). The averaged score from the listeners will serve as the speech intelligibility score of the participants.	Immediately after and 8 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysarthria Impact Profile (DIP)	DIP is an assessment tool designed to measure the psychosocial impact of dysarthria on affected individuals. It consists of several sections with statements rated on a five-point scale, ranging from "strongly agree" to "strongly disagree." DIP incorporates positively and negatively worded statements with differing scoring schemes. The fifth section prompts participants to list and rank their main concerns, including speech impairment. The final score indicates the global impact of dysarthria, with lower scores indicating a higher level of impact.	Immediately after and 8 weeks after treatment
Quality of Life in the Dysarthria Speaker	QoL-DyS is a patient-centered measure designed to evaluate the self-perceived quality of life in individuals with post-stroke dysarthria. This measure consists of 40 items, each rated on a scale of 0 (never) to 4 (all of the time). The questionnaire is divided into 4 parts, with 10 questions each, covering the following aspects: speech characteristics, situational difficulty, compensatory strategies, and perceived reactions of others.	Immediately after and 8 weeks after treatment
Carer Communication Outcomes After Stroke (CaCOAST)	CaCOAST assesses the carer's perception of the patient's communication effectiveness and its impact on their quality of life. The measure has 20 items, each assessed on a scale of 0 to 4, and a percentage summary measure is calculated. The first 15 items assess the carer's perception of the patient's communication, whereas the last 5 assess the impact of the patient's communication difficulties on the carer's quality of life.	Immediately after and 8 weeks after treatment
Speaking Rate (syl/s)	Changes in acoustic signals will be measured. Specifically, changes in the number of syllables per second (speaking rate) will be reported as slow speaking rate is a frequent speech characteristic of people with stroke.	Immediately after and 8 weeks after treatment
Acoustic vowel space (KHz)	Changes in acoustic signals will be measured. Specifically, changes in the size of acoustic vowel space (in KHz2) will be reported, as this is well known to be reduced in speakers with stroke and to correlate with speech intelligibility.	Immediately after and 8 weeks after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS)	SUS is a 10-item questionnaire (usability performance in the aspects of effectiveness, efficiency, and overall ease of use) with 5 response options for respondents, from strongly agree to strongly disagree. For the interpretation of the results, the scores are normalized and converted into a total score of 100. Based on research, a SUS score above 68 would be considered above-average usability, and above 80.3 would be considered excellent.	Immediately after and 8 weeks after treatment

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Study Director: Jinwoo Kim, PhD, Haii Corp.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: STUDY00004205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the nature of the data which will be collected (including voice), the investigators do not plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No