PITT Amputee Study

STUDY BASICS

Do you have a leg amputation? Do you use a prosthesis with a liner, and can you walk comfortably for at least 5 minutes with it? If so, you may be able to take part in a research study to find out if temperature control liners work better than standard liners. Compensation is provided.

STUDY PURPOSE

When a person suffers the loss of a body part (amputation), an artificial body part called a prosthesis can help the person return to their normal activities and functioning. A liner that fits over the residual limb is also often used to improve the comfort and functionality of the prosthesis, but many people who use these devices still experience discomfort and difficulty walking. The purpose of this study is to find out if prosthetic liners made with temperature control materials can help improve comfort and functionality of the prosthesis and increase activity levels and prosthetic usage in people with lower limb amputations. Researchers hope their findings will lead to better outcomes for people who use prosthetic devices.

COULD THIS STUDY BE RIGHT FOR YOU?

• Have a leg amputation
• Use liner suspension in your prosthesis
• Can walk comfortably for at least 5 minutes with your prosthesis

WHAT PARTICIPANTS CAN EXPECT

During an initial visit, researchers will measure your height, weight, foot size, and liner size, and provide participants with two new liners. Some participants will receive standard liners and some will receive temperature control liners. You will be asked to wear the new liners for 6 months. Every 6 weeks, you will have a 30-60 minute study visit where you will complete a questionnaire and 2-minute walk test. After 6 months, you will receive two new liners to wear for another 6 months. These liners will be a different material than the ones provided at the beginning of the study. After 12 months, you will have a final study visit. You will be permitted to keep the liners from the study.