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

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National

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.
Device: Dynavox Maestro
Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
Device: Experimental App
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

Axel Krieger

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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