Cerebral Palsy
Conditions
Brief 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.
Interventions
DEVICEDynavox Maestro
Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
DEVICEExperimental App
Participant receives experimental app to test speed and error rate of communication.
Sponsors
Axel Krieger
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speed of Communication | Immediately | Measure time (in minutes) to type 3 pre-set sentences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Error Rate of Communication | At time of experiment | Amount of typing errors per sentence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Dynavox Maestro and Experimental App |
|---|---|
| Age, Continuous | 10.6 years STANDARD_DEVIATION 4.3 |
| Gender Female | 2 Participants |
| Gender Male | 3 Participants |
| Region of Enrollment United States | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Speed of Communication
Measure time (in minutes) to type 3 pre-set sentences
Time frame: Immediately
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dynavox Maestro and Experimental App | Speed of Communication | Experimental App | 8.13 minutes | Standard Error 12.61 |
| Dynavox Maestro and Experimental App | Speed of Communication | Dynavox | 2.96 minutes | Standard Error 4.28 |
Secondary
Error Rate of Communication
Amount of typing errors per sentence
Time frame: At time of experiment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dynavox Maestro and Experimental App | Error Rate of Communication | Dynavox | 0.11 errors | Standard Deviation 0.4 |
| Dynavox Maestro and Experimental App | Error Rate of Communication | Experimental App | 0.12 errors | Standard Deviation 0.45 |