N/A
N=5
Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT02242994 ↗Enrolled (actual)
5
Serious AEs
—
Results posted
Dec 2016
Primary outcome: Primary: Speed of Communication — 8.13; 2.96 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dynavox Maestro (Device); Experimental App (Device)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Axel Krieger
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speed of Communication |
8.13; 2.96 | — |
| SECONDARY Error Rate of Communication |
0.12; 0.11 | — |
Summary
The purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App.
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 7 years old - 21 years old
- been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy.
- are able to communicate through written words
- are able to follow a 3- steps directions, and follow study directions and procedures.
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT02242994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.