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Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02242994
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Axel Krieger, Children's National Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Dynavox Maestro Device: Experimental App Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : March 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Speed of Communication [ Time Frame: Immediately ]
    Measure time (in minutes) to type 3 pre-set sentences


Secondary Outcome Measures :
  1. Error Rate of Communication [ Time Frame: At time of experiment ]
    Amount of typing errors per sentence


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242994


Locations
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United States, District of Columbia
Children's National
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Axel Krieger
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Axel Krieger, MD, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT02242994    
Other Study ID Numbers: Pro00003767
First Posted: September 17, 2014    Key Record Dates
Results First Posted: December 14, 2016
Last Update Posted: December 14, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases