Motor Speech Disorder, Stroke
Conditions
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).
Interventions
BEHAVIORALSmart-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.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech intelligibility on a visual analogue scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dysarthria Impact Profile (DIP) | 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. |
| Quality of Life in the Dysarthria Speaker | 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. |
| Speaking Rate (syl/s) | 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. |
| Acoustic vowel space (KHz) | 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. |
| Carer Communication Outcomes After Stroke (CaCOAST) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) | 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. |
Countries
United States
Outcome results
None listed