Speech Rehabilitation Based on Mobile Applications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Stroke Motor Speech Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Smart-phone based, self-driven speech rehabilitation

Intervention Type BEHAVIORAL

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.

Waitlist control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No