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Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
reprogramming assisted communication device interface
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:- Use of Dynavox ability to follow two-step commands impairment in arm function Exclusion Criteria:- increased risks of study

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children (with dystonia and controls)

Arm Description

Participants sat in a chair or their own wheelchair in front of a table whose surface height was adjusted at the midpoint between the hip and the Xiphoid process. They placed the hand that was not used for the task on their lap. An iPad® (Apple Inc, Cupertino, California) was located on the table in portrait mode in front of the participants at a distance that ranged between 40 and 55 cm. An adjustable metal bookstand supported the iPad® to allow the participants a comfortable screen view. The size of the screen was 19.5 × 14.6 cm. Custom software was developed for the experimental task (XCode 3.2 development environment, iOS 4.2 operating system; Apple Inc, Cupertino, California).

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 12, 2006
Last Updated
May 18, 2017
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00352326
Brief Title
Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity
Official Title
Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
For children who depend on devices to communicate, the rate of communication is a primary determinant of success. For children with motor impairments, the rate of communication may be limited by inability to contact buttons or cells rapidly or accurately. It is therefore essential to know how to adjust the device interface in order to maximize each child's rate of communication. The optimal rate of communication is determined by the Channel Capacity, which is the maximum value of the Information Rate for all possible keyboard button or cell layouts for the communication device. We construct a mathematical model for the information rate based on the relationship between movement time and the number of buttons per screen, the size of the buttons, and the length of a sequence of buttons that must be pressed to communicate each word in the vocabulary. We measure the parameters of the model using a custom-programmed touch-screen interface.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children (with dystonia and controls)
Arm Type
Experimental
Arm Description
Participants sat in a chair or their own wheelchair in front of a table whose surface height was adjusted at the midpoint between the hip and the Xiphoid process. They placed the hand that was not used for the task on their lap. An iPad® (Apple Inc, Cupertino, California) was located on the table in portrait mode in front of the participants at a distance that ranged between 40 and 55 cm. An adjustable metal bookstand supported the iPad® to allow the participants a comfortable screen view. The size of the screen was 19.5 × 14.6 cm. Custom software was developed for the experimental task (XCode 3.2 development environment, iOS 4.2 operating system; Apple Inc, Cupertino, California).
Intervention Type
Device
Intervention Name(s)
reprogramming assisted communication device interface
Intervention Description
The subjects were required to touch targets on the iPad® screen with the index finger of their preferred (less-affected) arm. The experimental task consisted of 180 targets divided in 4 blocks: 45 targets each block with a 1-minute interval between trials to avoid fatigue. Targets appeared at 1 of 9 different locations on the screen, and subjects moved their finger sequentially from one target to the next.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:- Use of Dynavox ability to follow two-step commands impairment in arm function Exclusion Criteria:- increased risks of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence D. Sanger
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity

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