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

NCT02242994 | Completed Results

• 1 other identifier: Pro00003767
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Speed of Communication

  Measure time (in minutes) to type 3 pre-set sentences

  Immediately

Secondary Outcomes (1)

• Error Rate of Communication

  At time of experiment

Study Arms (1)

Dynavox Maestro and Experimental App

EXPERIMENTAL

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; Device: Experimental App

Interventions

Dynavox Maestro DEVICE

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

Dynavox Maestro and Experimental App

Experimental App DEVICE

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

Dynavox Maestro and Experimental App

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Axel Krieger: lead

Study Sites (1)

Children's National

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Axel Krieger
• Organization: Children's National

akrieger@childrensnational.org

2024761284

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: September 17, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 14, 2016
• Results First Posted: December 14, 2016

Record last verified: 2016-10

Locations

US (1)