Back to resultsData Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynavox Maestro
Experimental App
Sponsored by
About this trial
This is an interventional basic science trial for Cerebral Palsy
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:
-
Sites / Locations
- Children's National
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynavox Maestro and Experimental App
Arm Description
Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
Outcomes
Primary Outcome Measures
Speed of Communication
Measure time (in minutes) to type 3 pre-set sentences
Secondary Outcome Measures
Error Rate of Communication
Amount of typing errors per sentence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02242994
Brief Title
Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Axel Krieger
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynavox Maestro and Experimental App
Arm Type
Experimental
Arm Description
Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.
Intervention Type
Device
Intervention Name(s)
Dynavox Maestro
Intervention Description
Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Intervention Type
Device
Intervention Name(s)
Experimental App
Intervention Description
Participant receives experimental app to test speed and error rate of communication.
Primary Outcome Measure Information:
Title
Speed of Communication
Description
Measure time (in minutes) to type 3 pre-set sentences
Time Frame
Immediately
Secondary Outcome Measure Information:
Title
Error Rate of Communication
Description
Amount of typing errors per sentence
Time Frame
At time of experiment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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:
-
Facility Information:
Facility Name
Children's National
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
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