Speech Rehabilitation Based on Mobile Applications

December 31, 2025 updated by: Yunjung Kim, Florida State University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speech intelligibility on a visual analogue scale (VAS)
Time Frame: Immediately after and 8 weeks after treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dysarthria Impact Profile (DIP)
Time Frame: Immediately after and 8 weeks after treatment
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
Time Frame: Immediately after and 8 weeks after treatment
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)
Time Frame: Immediately after and 8 weeks after treatment
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)
Time Frame: Immediately after and 8 weeks after treatment
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)
Time Frame: Immediately after and 8 weeks after treatment
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: Immediately after and 8 weeks after treatment
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jinwoo Kim, PhD, Haii Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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