Sunday, October 25, 2009

Testing Protocol as of 25 October 2009

Version 2, 10/21/09
WiiCane: An Accelerometer-based Tool for Mobility Training
Touch Graphics, Inc.
330 West 38th Street Suite 900
New York, New York 10018
Phone (212) 375-6341, Fax (646) 452-4211

Testing Protocol

Creation of the Device

The WiiCane project proposes to adapt the Wii gaming technology to develop a feedback device for long-cane mobility training for blind and deaf-blind children and adults.  The Nintendo Wii gaming console includes a small, lightweight, inexpensive WiiRemote component with accelerometer-based motion tracking.  The current project proposes to use this device attached to the shaft of a cane during mobility training.  The device will provide auditory or vibratory feedback to the cane user for immediate correction of movement and will also provide computerized tracking information for instructors and researchers.  The project will focus on the device’s ability to monitor two specific cane-use behaviors:  maintenance of the user’s direction within a straight line path; and cane arc width adequate to insure footfall preview (for hazard protection).  The objective is to create a device that is easy and fun for the user and that provides corrective feedback to improve cane mobility instruction and learning.  A diagram of the device is attached to Form 4.13B (Device) showing how the WiiRemote component is mounted below the handle of a cane, enabling it to pivot so that the camera can be directed either in front of the user or under the cane to monitor motion and direction. 

Verification Study

The first stage of product testing was a verification experiment.  This experiment has taken place at Western Michigan University at Kalamazoo.  This location was chosen in order to use the consultation services of Dr. Robert Wall Emerson of the University’s world-renowned Department of Blindness and Low Vision Studies.  The verification study has helped the development team confirm the accuracy of their proposed motion capture apparatus by comparing the data it collects with the known accuracy of the optical tools developed by Dr. Emerson.  The study also provided recommendations for improving the device’s measurement algorithms.  Since Dr. Emerson’s optical tracking equipment is too bulky and delicate to ship, it was preferable to conduct the verification study at his home site.  The subjects were ten sighted college students recruited through advertisements and classroom announcements.  

Since WMU maintains its own IRB, this experiment was submitted separately for review at their local IRB. Since the subjects were all over 18 years old, and since they wore blindfolds to simulate blindness, they were not considered a protected population, and we expected the IRB submission to qualify for expedited or exempt status.   This experiment, and its participants, are completely separate from the experiment in the current application to IRC; it is acknowledged here because of its common funding source and because it will result in information for improvement of the device to be used in the current study.
Recruitment and Consent Process

Following the verification study, the Testing Coordinator will contact staff at each of four test sites to identify potential participants for usability testing of the device, scheduled for November 2009. Test Sites and age ranges for recruitment are as follows; 8 participants per site, for a total of 32 participants, are anticipated.
  • Jewish Guild for the Blind, participant ages 2-4.
  • New York Institute for Special Education, participant ages 5-12.
  • Overbrook School for the Blind, participant ages 13-22.
  • Helen Keller National Center, participant ages 17-adult.
Testing will start with children aged six and older.  We will add younger children to the testing, at the sites indicated, only once success with older ones has been shown. 

Participants must be visually impaired, and must use mobility canes for independent travel. Participants at the Helen Keller National Center will be deaf-blind.  Participants at all sites should have no additional disabilities, including motor, cognitive or behavioral problems.  An appropriate staff person at each institution will be identified as a liaison to participants and will be responsible for collection and transmission of data as needed.  Once the liaison at each institution has identified qualified candidates, the liaison will contact adults, or children’s parent or guardian, to discuss the testing protocols, requirements for participating, payment for participation, and procedures put in place for the protection of human subjects in research. 
The liaison will contact potential participants or their parents by a letter either given to the adult participant or sent home with the child as is often done with parental permission slips.  If this is not feasible in an individual case, the letter script may be communicated by telephone or by e-mail.  A copy of the letter/telephone/e-mail script is provided as a separate document.  Students asked to participate will be given a consent form to give to their parent to sign and to bring back to the liaison.  Consent forms are provided as separate documents.  Students and parents will have time to consider the study and to ask questions before they have to make a decision.  As noted in the consent form, students or parents with questions about the study may contact the testing coordinator or the project evaluator.  Their names, e-mail addresses and home telephone numbers are given, and they will receive their messages every day.  The consent form also provides the e-mail address and phone number of IRC in case students or parents have questions about their rights as research subjects.  Willing participants or their parent will also receive an electronic version of the Pre-Participation Questionnaire.  This document assesses the participant’s degree of visual impairment, educational background and cane experience and is included in the IRC submission.  It will be administered and collected by the liaison.
Usability Testing
Usability testing will take place at the named sites over a four-week period, one week per site, beginning with participants aged six or older.  Younger children will be tested only after success with older children has been established.  The Co-PI for Pedagogy, who is a qualified orientation and mobility specialist on the project staff, and a testing assistant will conduct one to two sessions lasting around  one hour with each participant.  This time includes equipment setup, interview, preparation, trials with each participant, and a brief post-trial interview.  A staff member from the test site host organization will be present during all test sessions but will not administer the testing.   

Participants or their parent will be told both in the consent form and at the time of testing that we want them to try out the device to see if it is useful and to solicit their reactions for the purpose of improving the product, not to evaluate them personally.  In each session, the participant will first try out the WiiCane device, making sure that he or she understands the meanings of various feedbacks (either audible or vibratory, or, in the case of the deaf-blind participants, only vibratory).  Next, the participant will be asked to walk along a 30-foot-long course, using the WiiCane as a mobility aid.  The computer will monitor their movements and will generate a complete record of their performance in each session.  Benign auditory or vibratory signal feedback will be sent from the computer to the participant through the device or through wireless headphones, and the system will log for future analysis the participant’s ability to use the feedback to correct behaviors that fall outside pre-set allowable ranges. In order to insure uniformity of vision across subjects, partially-sighted participants will be asked to wear a customized occluded goggle so that they cannot use vision to alter their cane use.  This will be explained in advance in the consent form.  Participants who consent but then express anxiety at wearing the goggle will be allowed to discontinue their participation with full payment.  At the end of testing, participants will be asked a series of questions designed to elicit their responses to the system.

Payment to participants ($150 plus travel reimbursement) will be made in cash on completing the session, and they will sign a receipt.  It will be given directly to the adult participant or to an accompanying parent.  Payment will be made to all participants who attend the session, even if they choose not to complete the study.  Payment will not be made to students who do not attend the session.

Data analysis will focus on the usability and effectiveness of the remote feedback to improve participants’ cane use for the two behavioral criteria (maintenance of a straight line path and use of a proper-sized cane arc).  All records will be maintained by Dr. Annette Gourgey, project evaluator, for a period of five years.  All participants will be identified by an ID number and Dr. Gourgey will be the only person in possession of the master list of names and numbers.  Only Mr. Landau and Drs. Bourquin and Gourgey will have access to the records.

The long-term goal is consistent with Touch Graphics, Inc.’s practice of conducting high quality research and converting the findings to practical and needed assistive and accessible educational materials.  Thus, the Company will seek to make necessary changes to the WiiCane system as suggested by the research outcomes, to be followed by a product roll-out within one year of the end of the project.  We will design and manufacture a custom cane that includes a pivoting fixture for mounting the WiiRemote device.  The software will run on any PC that has Bluetooth capability (normally included with most recent laptops, and easy to add to desktop models and older laptops with an inexpensive expansion card).  With the addition of Owner’s Manuals and packaging and promotional materials, we hope to start selling up to 100 systems per year, at a total cost to an organizational customer of $1,200, including setup and training.  Realistically, students could begin training on the WiiCane as early as late 2010. 

No comments: