The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic foot offers a reduction of the amount of oxygen used while walking, if stability is improved over current prosthetic feet, and whether the experimental device actually increases activity in amputees.
Tensegrity Prosthetics' objectives are to test whether the K3 Promoter prosthetic foot affects walking efficiency or stability in trans-tibial unilateral amputees when compared to their current prostheses. The primary objectives are to determine if the experimental foot changes Cost of Transport (ml O2/kg/meter) or Stride Time Variability compared to an amputee's current prosthesis. Cost of Transport is an indicator of metabolic efficiency and Stride Time Variability indicates how likely a person is to fall. Oxygen consumption and stride time will be collected on a treadmill at the Gait and Motion Lab at the University of Colorado in Boulder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Experimental prosthetic foot
University of Colorado Gait Lab
Boulder, Colorado, United States
Change in metabolic cost of transport
Time frame: 30 and 60 days after the beginning of the protocol
Stride time variability
Time frame: 30 and 60 days after beginning of protocol
Amputee Mobility Predictor Questionnaire
Time frame: Beginning and end of protocol
Actual change in activity as measured by a step counter
Time frame: throughout protocol (60 days)
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