- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242994
Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
October 24, 2016 updated by: Axel Krieger
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Children's National
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Participant receives experimental app to test speed and error rate of communication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speed of Communication
Time Frame: Immediately
|
Measure time (in minutes) to type 3 pre-set sentences
|
Immediately
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Error Rate of Communication
Time Frame: At time of experiment
|
Amount of typing errors per sentence
|
At time of experiment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
July 24, 2014
First Submitted That Met QC Criteria
September 15, 2014
First Posted (Estimate)
September 17, 2014
Study Record Updates
Last Update Posted (Estimate)
December 14, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00003767
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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