SOFT ACTIVE ANKLE-FOOT ORTHOTIC

INTRODUCTION

You are invited to participate in a research study to validate the functionality of a new soft active ankle-foot orthotic (AAFO), intended to be used to mitigate the effects offoot drop condition. The decision to join, or not to join, is up to you. In this research study, we are testing a new ankle-foot orthotic prototype in an effort to determinewhether or not our new device is comfortable to wear, easy to use, and aesthetically pleasing.

WHAT IS INVOLVED IN THE STUDY?

You will be asked to test the new device by wearing it and walking across a room on flat ground. Following this activity, the device willbe removed, and you will be asked to complete a brief survey. This study will take approximately 10 minutes to complete. The investigators may stop the study or take you out of the study at any time they judge it is in your best interest. You can stop participating atany time.

RISKS

This study involves a few minor risks. The first is the possibility ofminor leg discomfort if the device is applied too tightly. However, you will be able to make anynecessary adjustments to the device, at any time, using the Velcro straps.Additionally, you may recognize that your gait changes while wearing the device. If this occurs and you are uncomfortable with this feeling, you may ask to stop the study. Lastly, you will wear a backpack that weighs approximately 6.5 pounds in this study and due to the weight, minor muscle fatigue pain may be felt in the back; however, this amount is expected to be less than or equal to that caused by a typical school backpack.These are the primary risks associated with this study; however, there may also be other risks that we cannot predict.

BENEFITS TO TAKING PART IN THE STUDY

The device you will be testing is only a prototype and will not be available for immediate use. It is reasonable to expect thatthis study will result in better knowledge of what will make an ankle-foot orthotic more comfortable and user friendly; however, we can’tguarantee that you will personally experience benefits from participating in this study. Others may benefit in the future fromthe information we find in this study.

CONFIDENTIALITY

Your name will not be used if data from this study ispresented to an audience. Every effort will be made to keep your informationconfidential. We will take the following steps to keep information about you confidential, and to protect it from unauthorizeddisclosure, tampering, or damage. The RIT researchers will store all informationon a password-protected server at RIT,accessible only to researchers working on this study.

INCENTIVES

There are no incentives for participating in this study.

YOUR RIGHTS AS A RESEARCH PARTICIPANT?

Participation in this study is voluntary. You have the right not to participate at all or to leave the study at any time. Decidingnot to participate or choosing to leave the study will not result in any penalty or loss of benefits to which you are entitled. Ifyou decide to leave the study, you must notify the researcher identified below by phone or email. If you leave the study, anysurvey information you have already provided to us will remain as part of the study.

CONTACT FOR QUESTIONS OR PROBLEMS?

If you have any questions about the study or any problems, please contact:

Geni Giannotti- email:

Adam Podolec- email:

Consent of Subject (or Legally Authorized Representative)

Signature of Subject or Representative Date

______

(Upon signing, the subject or the legally authorized representative will receive a copy of this form, and the original will be heldin the subject’s research record.)

Anticipated User Survey for Prototype Testing

Aesthetics:

1.)Compared to current commercially-available ankle-foot orthotics,would you consider this device aesthetically pleasing? (better, same, worse)

Commercially
Available AFO / Rating for our device
(circle one answer for each device)
/ Better / Same / Worse
/ Better / Same / Worse
/ Better / Same / Worse
/ Better / Same / Worse

2.)Are there any specific features that make our device not aesthetically pleasing? Please be specific and feel free to offer suggestions for improvement.

Application:

1.)How long did it take you to put on the device? How long to remove it? Record times in the provided spaces below. Note: we will time each event for you.

Application: ______minutes, ______seconds

Removal: ______minutes, ______seconds

2.)Using the scale below, please rate the difficulty of device application (circle a number)

1 2 3 4 5

3.)Are there specific parts/areas of the device that make it difficult to put on? Please be specific and feel free to offer suggestions for improvement.

Comfort:

1.)Please rate the comfort of this device by circling one of the numbers (1-10) on the scale below.

2.)Are there specific parts/areas of the device that make it uncomfortable to wear? Please be specific and feel free to offer suggestions for improvement.