Clinical trial NCT06592183: Speech Rehabilitation Based on Mobile Applications
Official title: Effect of Speech Rehabilitation Based on Mobile Application for People With Dysarthria After Stroke: A Single-Center, Investigator-Blinded, Randomized, Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Motor Speech Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Speech intelligibility on a visual analogue scale (VAS)
timeFrame: Immediately after and 8 weeks after treatment
Secondary outcomes:
measure: Dysarthria Impact Profile (DIP)
timeFrame: Immediately after and 8 weeks after treatment
measure: Quality of Life in the Dysarthria Speaker
timeFrame: Immediately after and 8 weeks after treatment
measure: Carer Communication Outcomes After Stroke (CaCOAST)
timeFrame: Immediately after and 8 weeks after treatment
measure: Speaking Rate (syl/s)
timeFrame: Immediately after and 8 weeks after treatment
measure: Acoustic vowel space (KHz)
timeFrame: Immediately after and 8 weeks after treatment
Other outcomes:
measure: System Usability Scale (SUS)
timeFrame: Immediately after and 8 weeks after treatment
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Haii Corp.
name: Jinwoo Kim, PhD
role: STUDY_DIRECTOR
References: