About this trial
The primary objective of this pilot study is to evaluate the feasibility and preliminary effectiveness of the Voiceitt app in improving communication for individuals with speech impairments due to conditions such as cerebral palsy (CP), stroke, Amyotrophic Lateral Sclerosis (ALS), or Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 13 or older
moderately severe speech dysarthria due to conditions such as CP, stroke, ALS or Parkinson's Disease, etc.
Ability to understand and follow instructions for using the Voiceitt app.
Disqualifiers
Severe cognitive impairments that prevent the understanding of the Voiceitt app and required training.
Patients who have additional speech impairments other than dysarthria, such as significant aphasia or verbal apraxia.
Severe physical impairments that prevent interaction with the app.
Non-English speakers.
Trial design
Single group
Treatments tested in this trial
Voiceitt
Other interventionParticipants will use Voiceitt App
Treatment groups
Trial outcomes
Primary outcomes
Change in Communication Abilities as measured by SIR
Change in Communication Abilities as measured by Speech Intelligibility Rating (SIR) that quantifies clarity of speech. The rating ranges from 1-5. low rating means speech is unintelligible, and highest rating means speech is intelligible to all listeners. Change in SIR is measured by administering SIR at 3 different time points, at baseline, and two times after intervention.
Change in Communication Abilities as measured by Communication Effectiveness Index (CETI)
Change in Communication Abilities as measured by Communication Effectiveness Index (CETI) that measures perceived effectiveness of communication in daily activities. CETI is a 16 item questionnaire. Each item is scored from 1-100. The final score of CETI is the averaged score across the 16 items, and ranges from 1-100. A high score indicates good performance in functional communication and a low score, poor performance. Change in CETI is measured by administering CETI at 3 different time points, at baseline, and two times after intervention.
Secondary outcomes
User Satisfaction
User satisfaction is assessed through surveys and interviews focusing on ease of use, satisfaction with the app, and perceived changes. The survey uses Likert-type scale where users choose the answer option that represent their assessment of the app on several usability questions. An example of the question-and-answer choices is "How easy was it to set up the Voiceitt app? Very easy, Easy, Neutral, Difficult, Very difficult." Reported data will be a combination of frequency of participants choosing favorable and unfavorable answer choices, and a qualitative analysis based on participants' responses to the survey and interview.
Change in Communication-Related Frustration
Self-reported change in frustration levels during communication.
Change in Participants' Accounts on Social Interaction Quality
Through qualitative interviews, participants will be asked about how the app influenced their social interactions and participation in daily activities. This information will be reported qualitatively as themes using qualitative analysis.
Sponsors and contacts
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University of Pittsburgh
Lead sponsor
Duquesne University
Collaborator