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

NCT ID: NCT02242994

Last Updated: 2016-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dynavox Maestro

Intervention Type DEVICE

Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.

Experimental App

Intervention Type DEVICE

Participant receives experimental app to test speed and error rate of communication.

Interventions

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Dynavox Maestro

Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.

Intervention Type DEVICE

Experimental App

Participant receives experimental app to test speed and error rate of communication.

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

7 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axel Krieger

OTHER

Sponsor Role lead

Responsible Party

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Axel Krieger

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Children's National

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00003767

Identifier Type: -

Identifier Source: org_study_id