Language for the Website on the C Leg Project:

Clinical Trial Evaluation:

The Microprocessor Control C Leg

Versus Traditional Non-microprocessor Transfemoral Prosthesis

With the introduction of the C Leg, the prosthetics industry has not seen as dramatic an improvement in component technology since the inception of energy storing foot technology. The evolution of knee technology such as the C Leg has been validated in recent investigations throughout the industry. These studies have shown that with use of the C Leg there is a significant change in gait, stamina and psycho-social well-being (Otto Bock, C Leg Participant, 1997). However, this research has been limited in scope in that it has not include patient pre and post C Leg activity levels, and on the patient’s well being in a real world environment.

PRS is currently conducting a research study on the comparison of the C Leg to a traditional non microprocessor (NMP) prosthesis at the time just before, during and after a transition to a C Leg. The purpose of this research is to provide a comprehensive “real world” view of the microprocessor technology currently available to users. [LLW1]In so doing, we surmise that funding agencies will be better educated as to the direct incentives both qualitatively and quantitatively for increasing the access to the beneficial prosthetic technologies.

Currently, we are studying a population of 20 transfemoral (above the knee) amputees in a range of ages and functional levels over two years. In this study, PRS will evaluate each group to determine why people choose, continue to use and prefer one prosthesis over another as well as to document the functional differences between the two systems.[LLW2]

Thisstudy will not only highlight the functional capabilities of the C Leg, but also it will highlight the strength of individual choice and preference through all activity levels. As it is designed, the study outcomes will provide clinical data and performance documentation illustrating the C Leg’s functionality in a real world setting.

In order to accomplish this several activities have been determined:

  • Conduct a clinical trial to emulate and participant a real world situation where 20 patients transfer from a non-microprocessor (NMP) prosthesis to an Otto Bock 3C100, (C Leg).
  • Two unique participant groups; Geriatric (K-2) and Active (K-3-4) in order to capture the different functionality benefits of using the C Leg system. For each group we will collect objective gait and validated preference & satisfaction data during this multiphase study. In order to do this, several outcomes measurements tools are being used
  • In order to provide quantitative and qualitative data, we will use existing scientifically validated measurement tools and tools developed specifically for this research;
  • Quantitative Tools:
  • Amputee Mobility Predictor (AMP), Robert Gailey, PhD PT
  • Divided Attention Task, “Walk & Talk”, PRS
  • Stair Assessment Index (SAI), PRS
  • Hill Assessment Index (HAI), PRS
  • Obstacle Course, PRS
  • Qualitative Tools:
  • Prosthesis Evaluation Questionnaire (PEQ), PRS
  • Addendum: Falls & Mental Energy, PRS
  • Short Form 36 (SF 36), MOS

[LLW1]Mui Importante: please leave.

[LLW2]Mui Importante, please keep.