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

Cerebral Palsy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02242994
• Other study ID #: Pro00003767
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2014
• Last updated: January 15, 2016
• Start date: March 2014

Study information

• Verified date: January 2016
• Source: Children's Research Institute
• Contact: Ryan S Decker, MS
• Email: rdecker[@]cnmc.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 21 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Dynavox Maestro
Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
• Experimental App
Participant receives experimental app to test speed and error rate of communication.

Locations

Country	Name	City	State
United States	Children's National	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Axel Krieger

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed of Communication	Measure time (in minutes) to type 3 pre-set sentences	Immediately	No
Secondary	Error Rate of Communication	Amount of typing errors per sentence	At time of experiment	No