Hello List Serve Community,
*OP Solutions* is recruiting subjects for a research study titled
“Prosthetic Smart Socket Technology to Improve Patient Interaction,
Usability, Comfort, Fit, and Function”
*PURPOSE* The purpose of this study is to determine whether a prosthetic
socket that notifies its user via smartphone prompt of excessive distal
pressure will improve user sock ply compliance. Once prompted the user
knows to adjust the sock ply which they are using, potentially decreasing
distal pressure, reducing skin and functional problems more effectively
than relying upon the usual feedback and standard prosthetic fit protocols
and practices.
*INCLUSION CRITERIA*
1. Unilateral transtibial amputation
2. Must be new or revision amputation or unstable volume fluctuation
3. Candidate for intermediate stage socket fitting, not yet fit into their
first socket
4. Male or female, of any ethnicity
5. 18-75 yrs of age
6. 100-275lbs
*TIME COMMITMENT* Complete participation in the study lasts 120 days. After
fitting the new prosthesis there will be 4 data collections following the
fitting at 30, 60, 90, and 120 days.
*LOCATION *The prosthetic clinic where the subject receives normal care.
*BENEFITS OF PARTICIPATION *There is no cost to participate in this study.
Subjects can receive up to $500 for their participation and the benefit of
an Alps iForce. The prosthetist will receive the prosthesis at no cost.
This includes a Variflex foot, a finished flex interface graphite frame
socket, iForce, 2 liners, 2 suspension sleeves, and 12 socks. You will have
access to the data for clinical use after the data collection is complete.
*IF YOU ARE INTERESTED IN PARTICIPATING *Contact us with a prospective
subject. We will provide an informed consent document and discuss all the
risks and rewards with the subject. Once they have provided informed
consent, proceed with fitting into the check socket. We will ship all
components and fabricate the socket with the iForce within 7 business days.
Once the socket is fit, you will log into the data collection site and
proceed with data collection.
***If you are a Prosthetist who has a subject interested in participating
in this study or more information, please contact: Jason Kahle MSMS, CPO *
*Phone (866)990-0888 *
*E-mail [email protected]
*Study funded by U.S Department of Defense. In collaboration with the
University of South Florida School of Physical Therapy and Rehabilitation
Sciences. Clinical Trials.gov NCT03199222
—
*Magen Koch*
*General Manager *
*866-990-0888 <866-990-0888>*
*OPSolutions.us
*
