NCT06874322

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

February 21, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 25, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

February 21, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

Speech Impairmentvoice recognition tooldictation toolvoice recognition appdictation appvoiceitt appspeech disabilitiesdysarthriamoderate dysarthria

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline (Day 1), 5-6 months, and 7-8 months

  • 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.

    Baseline (day 1), 5-6 months, and 7-8 months

Secondary Outcomes (3)

  • User Satisfaction

    7-8 months

  • Change in Communication-Related Frustration

    7-8 months

  • Change in Participants' Accounts on Social Interaction Quality

    7-8 months

Study Arms (1)

Voiceitt

EXPERIMENTAL

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/

Other: Voiceitt

Interventions

Participants will use Voiceitt App

Voiceitt

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Assistive Technology

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Speech DisordersDysarthria

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArticulation Disorders

Study Officials

  • Brad E Dicianno, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brad E Dicianno, MD

CONTACT

Zara Ambadar, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2025

First Posted

March 13, 2025

Study Start

June 25, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations