Trial Outcomes & Findings for Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy (NCT NCT02242994)

Results Overview

Measure time (in minutes) to type 3 pre-set sentences

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Immediately

Results posted on

2016-12-14

Participant milestones
Measure	Dynavox Maestro and Experimental App Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. Experimental App: Participant receives experimental app to test speed and error rate of communication.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy

Baseline characteristics by cohort
Measure	Dynavox Maestro and Experimental App n=5 Participants Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. Experimental App: Participant receives experimental app to test speed and error rate of communication.
Age, Continuous	10.6 years STANDARD_DEVIATION 4.3 • n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

Timeframe: Immediately

Measure time (in minutes) to type 3 pre-set sentences

Outcome measures
Measure	Dynavox Maestro and Experimental App n=5 Participants Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. Experimental App: Participant receives experimental app to test speed and error rate of communication.
Speed of Communication Experimental App	8.13 minutes Standard Error 12.61
Speed of Communication Dynavox	2.96 minutes Standard Error 4.28

Timeframe: At time of experiment

Amount of typing errors per sentence

Outcome measures
Measure	Dynavox Maestro and Experimental App n=5 Participants Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. Experimental App: Participant receives experimental app to test speed and error rate of communication.
Error Rate of Communication Experimental App	0.12 errors Standard Deviation 0.45
Error Rate of Communication Dynavox	0.11 errors Standard Deviation 0.40

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Children's National

Phone: 2024761284