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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Congenital/Traumatic | Experimental | Individuals who were born with a limb deficiency or who have had a traumatic amputation. |
|
| Dysvascular/Diabetic | Experimental | Individuals who have had an amputation as a result of vascular disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental prosthetic foot (K3 Promoter) | Device | Experimental prosthetic foot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in metabolic cost of transport | 30 and 60 days after the beginning of the protocol | |
| Stride time variability | 30 and 60 days after beginning of protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Amputee Mobility Predictor Questionnaire | Beginning and end of protocol | |
| Actual change in activity as measured by a step counter | throughout protocol (60 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jerome Rifkin, MS ME | Contact | 303-666-7722 | jrifkin@tenspro.com |
| Name | Affiliation | Role |
|---|---|---|
| Jerome Rifkin, MS ME | Tensegrity Prosthetics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Gait Lab | Boulder | Colorado | 80310 | United States |
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