UNLV PROSPER Trial — Pre-Screening

Screening Consent — Department of Physical Therapy

TITLE OF STUDY: PROSthetic PERformance enhancement trial (PROSPER) – Screening.

INVESTIGATOR: Dr. Jenny A. Kent, PhD, CSci.

For questions or concerns about the study, you may contact Dr. Kent at jenny.kent@unlv.edu or 702-895-5949. For questions regarding the rights of research subjects, any complaints or comments regarding the manner in which the study is being conducted, contact the UNLV Office of Research Integrity – Human Subjects at 702-895-2794 or via email at IRB@unlv.edu.

KEY INFORMATION SUMMARY

You are being invited to participate in a research study. Participation in research is completely voluntary.
The purpose of the research is to test a simple walking training program that may improve lower limb prosthesis users' mobility and walking confidence. This consent form only refers to the screening portion of the study, which will determine whether you are eligible to participate in the main study.
The screening will take 15 minutes and you will be asked to answer some questions. The information will be stored for future use, without your name and any identifiers attached to it.
Risks and/or discomforts may include the risk of breach of confidentiality.
There is no direct benefit to you from participating in this screening procedure.

DETAILED INFORMATION

PURPOSE OF THE STUDY. The overall goal of our research is to find out if prosthesis users can improve their walking skill and confidence by training on uneven surfaces. As a first step in this research, we have developed a training program and mobility assessments but need feedback from prosthesis users to make improvements. The study will involve four weeks of training at UNLV's Maryland Campus. You would be walking on either a treadmill or a mat, and either on a bumpy or a flat surface. The goal is for you to complete the training sessions three times per week. Additionally, you will also be asked to attend two assessment sessions and to wear an activity monitor for two weeks. We will also ask for your feedback about your experiences with the training and assessments using surveys. You will be compensated up to $325 in incremental gift card payments for participating in this study. You are being invited to join this research study because you may fit the eligibility criteria. The purpose of this screening is to find out whether you are eligible to participate in the main study. The information you provide will also be used to help us find out more about how we may best adapt the methods of future studies to include people who may benefit from this research.

PROCEDURES DURING THIS SCREENING. To find out whether you are eligible, you will be asked questions about your background, your medical history, and your prosthesis. You will additionally be asked to complete two questionnaires about balance confidence and mobility. After the screening, your responses will be reviewed by study personnel, who may ask you further questions to help determine whether you are eligible for the study. If you are eligible to be in the study and you are interested in participating, you will be given another consent form to read and sign. That consent form will further explain the procedures, risks, and potential benefits of the main study. Your study participation in the screening portion of the study will take a total of approximately 15 minutes. The screening procedure will take place either by electronic questionnaire, virtually (by phone or secure video call) or in person.

BENEFITS OF PARTICIPATION IN SCREENING. Participating in the screening procedures will determine whether you are eligible for the study. There is no other direct benefit to you from participating in the screening procedures. If these procedures show that you are eligible and you are considering participating in the main study, then a comprehensive review of the experimental procedures, risks, and potential benefits of the main study will be discussed with you at that time.

RISKS OF PARTICIPATION IN SCREENING. Breach of confidentiality: As with all research there is a risk that confidentiality could be compromised if an unauthorized person gains access to your data. This risk is reduced by our data security measures including password protected logins.

COST / COMPENSATION. There is no financial cost to you, and you will not be paid for taking part in this screening.

CONFIDENTIALITY. Your deidentified screening information will be kept as confidential in a secure, password-protected database and/or locked file cabinets. You will not be identified in any written or oral materials that could link you to this study. Data from this screening may be shared with the research community at large to advance science and health. We will remove all personal information that could identify you before any data files are shared with other researchers. This study is classified as a clinical trial and we will publish summary results from the study, including screening data, in scientific journals, and report results at scientific conferences. No screening or study participants will be identified in any of those summary results. In addition to the above, representatives of the Department of Defense are authorized to review research records.

VOLUNTARY PARTICIPATION. Your participation in this screening is voluntary. You may refuse to participate in this screening. The only alternative to participating in the screening procedures is not to participate. You may withdraw at any time without prejudice to your relations with UNLV. If you have questions about the screening process you are encouraged to contact the study team at humancapabilitylab@unlv.edu or 702-895-1254.

PARTICIPANT CONSENT: I have read the above information and agree to participate in this screening. I have been able to ask questions about the screening process and the research study. I am at least 18 years of age. A copy of this form has been given to me to keep.

Full consent document

Do you agree to answer the screening questions?

Yes No

Full Name

By signing below I confirm that I have read the screening consent information above, I agree to participate in this screening, and I am at least 18 years of age.

Use your mouse or finger to draw your signature. Tap Clear to start over.

Email Address

Mobile Phone Number

Date of Birth

Format: Month/Day/Year (e.g., 01/15/1980)

City and State

Where do you currently live?

Thank you for your time. If do not meet the criteria to enroll into this particular study would you like us to contact you again if another study comes up for which you might qualify to participate in?

Yes No

Future Study Interests

Have you had a lower limb amputation or absence at the ankle level or above (on one or both sides)?

Yes No

Do you use a prosthetic limb for walking?

Yes No

Do you use your prosthetic limb regularly for walking — that is, as a regular part of your daily activities?

Yes No

Are you able to walk for at least 3 minutes at a time, with or without a walking aid or assistive device?

Yes No

Was your prosthetic limb fitted by a trained prosthetist?

Yes No

Are you able to travel to the UNLV campus in Las Vegas, Nevada, for study visits?

Yes No

Which side(s) is your lower limb amputation on?

Unilateral – Left side Unilateral – Right side Bilateral (both sides)

My LEFT lower limb amputation level is:

Symes (through the ankle) Transtibial (below the knee, above the ankle) Knee disarticulation (through the knee) Transfemoral (above the knee, below the hip) Hip disarticulation (through the hip) Hemipelvectomy (through the pelvis) Other

You selected 'Other' for your left side — please briefly describe the level of your left lower limb amputation.

My RIGHT lower limb amputation level is:

Symes (through the ankle) Transtibial (below the knee, above the ankle) Knee disarticulation (through the knee) Transfemoral (above the knee, below the hip) Hip disarticulation (through the hip) Hemipelvectomy (through the pelvis) Other

You selected 'Other' for your right side — please briefly describe the level of your right lower limb amputation.

The cause of my amputation(s) is: (Select all that apply)

Traumatic Vascular Congenital Other

You selected 'Other' for cause of amputation — please briefly describe the cause.

I have an upper limb amputation or absence at the wrist or above (on one or both sides):

Yes No

The skin on my residual limb(s) has sore spots:

Never Rarely Sometimes Frequently Always

The skin on my residual limb(s) has ulcers (open sores):

Never Rarely Sometimes Frequently Always

The skin on my residual limb(s) breaks down when I walk:

Never Rarely Sometimes Frequently Always

I have pain in my residual limb(s) when I walk:

Never Rarely Sometimes Frequently Always

On a scale of 0–10, where 0 is the most uncomfortable socket fit you can imagine and 10 is the most comfortable, how would you score the comfort of your socket at the moment?

Enter a whole number from 0 (least comfortable) to 10 (most comfortable).

Health conditions

Answering 'Yes' to any of these does not necessarily preclude your participation in this study. Please select all that currently apply.

Do you have any of the following? (Select all that apply)

If you answered 'Yes' to any health conditions above, please provide further information. You can also note anything you are unsure about, or anything not listed that may be relevant to the study.

Are you currently pregnant, or is there any chance you could be pregnant?

Yes No Not sure

Are you currently receiving physical therapy treatment to improve your walking?

Yes No

Do you think you will likely be receiving physical therapy treatment to improve your walking in the next six months?

Yes No

Have you ever used a treadmill since your lower limb amputation?

Yes No

Have you walked on a treadmill for 60 minutes or more in total since your amputation?

Yes No

My age (in years):

My sex assigned at birth:

Male Female Other Don't wish to answer

My gender:

Woman Man Transgender Woman Transgender Man Non-binary Agender (I don't identify with any gender) Gender not listed Don't wish to answer

My gender is...

I am of Hispanic, Latino, or of Spanish origin:

Yes No Don't wish to answer

I would describe myself as: (select one or more)

American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White Don't wish to answer

How did you hear about this study?

Activities-specific Balance Confidence (ABC) Scale

For each activity, indicate your confidence doing it without losing your balance or becoming unsteady, from 0% (no confidence) to 100% (completely confident). If you do not currently do the activity, imagine how confident you would be. If you normally use a walking aid or hold onto someone, rate your confidence as if using those supports.

How confident are you that you will not lose your balance or become unsteady when you…

…walk around the house?

…walk up or down stairs?

…bend over and pick up a slipper from the front of a closet floor?

…reach for a small can off a shelf at eye level?

…stand on your tip toes and reach for something above your head?

…stand on a chair and reach for something?

…sweep the floor?

…walk outside the house to a car parked in the driveway?

…get into or out of a car?

…walk across a parking lot to the mall?

…walk up or down a ramp?

…walk in a crowded mall where people rapidly walk past you?

…are bumped into by people as you walk through the mall?

…step onto or off of an escalator while you are holding onto a railing?

…step onto or off an escalator while holding onto parcels such that you cannot hold onto the railing?

…walk outside on icy sidewalks?

PLUS-M Mobility Questionnaire

Please respond to all questions as if you were wearing the prosthetic leg(s) you use most days. If you would normally use a cane, crutch, or walker for the task, answer as if you were using that device.

Choose “Unable to do” if you would need help from another person, would need a wheelchair or scooter, or feel the task may be unsafe for you.

Are you able to walk a short distance in your home?