TTAS : Transtibial Socket Amputee Study

STUDY BASICS

Do you have a below the knee amputation? Do you use a conventional socket prosthetic? You may be eligible for a research study to to develop a novel Socket Suspension System fit monitor. Compensation is provided.

STUDY PURPOSE

This study will provide a better understanding of the novel Socket Suspension System fit monitor that will monitor socket fit based on relative motion between the residual limb and the prosthetic socket. It is possible there will be generalized knowledge to the medical and research community as a result of this study, including but not limited to improving the outcomes for patients with a below-knee amputation. 

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants:

• Are 18-80 years old 
• Have an amputation below the knee
• Use a conventional socket prosthetic
• Are not pregnant 

WHAT PARTICIPANTS CAN EXPECT

There will be three groups of study participants for this study. Groups 1 and 2 will be capable of walking for 5-10 minutes without assistance/assistive devices. Group 3 will be capable of walking on a treadmill for 5-10 minutes without assistance/assistive devices. A research CT scan of the residual limb is required for participants in Groups 1 and 2.

Group 1: The participants will complete a total of 14 overground walking trials while wearing reflective markers on their body and beads on the skin of their residual tibia. Each participant will wear their normal socket (7 trials) and normal socket with a reduced liner (7 trials). 

Group 2: The participants will complete a total of 14 overground walking trials while wearing their normal socket (7 trials) and normal socket with the fit monitor (7 trials). 

Group 3: The participants will complete 10 minutes walking on the treadmill while wearing the fit monitor and reflective markers on their body. No radiographic imaging will be collected.