NCT00352326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

8.9 years

First QC Date

July 12, 2006

Last Update Submit

May 18, 2017

Conditions

Study Arms (1)

Children (with dystonia and controls)

EXPERIMENTAL

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).

Device: reprogramming assisted communication device interface

Interventions

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.

Children (with dystonia and controls)

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Terence D. Sanger

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 14, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations