- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874322
Voiceitt for People With Impairments in Speech
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Conditions like CP, ALS, Stroke or Parkinson's disease, etc., cause communication impairment. There are few augmentative communication options that allow people with these impairments to communicate effectively.
Voiceitt is an app that is designed to assist people with speech impairments by using a voice recognition and dictation tool that adapts to users' unique, non-standard speech patterns. However, its effectiveness in clinical populations has not been established. This study is bridging the gap in evaluating the preliminary effectiveness and feasibility of Voiceitt app in improving communication among people with mild to moderate speech impairments.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brad E Dicianno, MD
- Phone Number: (412) 648-6666
- Email: dicianno@pitt.edu
Study Contact Backup
- Name: Zara Ambadar, Ph.D
- Phone Number: 4126086118
- Email: ambadar@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- Center for Assistive Technology
-
Contact:
- Brad E Dicianno, MD
- Phone Number: (412) 648-6666
- Email: dicianno@pitt.edu
-
Contact:
- Katya Hill, PhD, CCC-SLP
- Phone Number: 412-383-6659
- Email: khill@pitt.edu
-
Principal Investigator:
- Brad E Dicianno, MD
-
Sub-Investigator:
- Katya Hill, PhD,CCC-SLP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Voiceitt
Participants will use Voiceitt App.
Voiceitt is a voice recognition and dictation tool that adapts to users' unique, non-standard speech patterns.
It integrates with mainstream devices and platforms to enable communication, accessibility, and independence for people with speech disabilities.
https://www.voiceitt.com/
|
Participants will use Voiceitt App
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Communication Abilities as measured by SIR
Time Frame: Baseline (Day 1), 5-6 months, and 7-8 months
|
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.
|
Baseline (Day 1), 5-6 months, and 7-8 months
|
|
Change in Communication Abilities as measured by Communication Effectiveness Index (CETI)
Time Frame: Baseline (day 1), 5-6 months, and 7-8 months
|
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.
|
Baseline (day 1), 5-6 months, and 7-8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User Satisfaction
Time Frame: 7-8 months
|
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.
|
7-8 months
|
|
Change in Communication-Related Frustration
Time Frame: 7-8 months
|
Self-reported change in frustration levels during communication.
|
7-8 months
|
|
Change in Participants' Accounts on Social Interaction Quality
Time Frame: 7-8 months
|
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.
|
7-8 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brad E Dicianno, MD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY24100164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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