A Comparison of External Mechanical Work Between Different Prosthetic Feet (SEW)
Traumatic Amputation of Lower Extremity
About this trial
This is an interventional treatment trial for Traumatic Amputation of Lower Extremity
Eligibility Criteria
Inclusion Criteria:
Males and/or Females between the ages of 40 and 65. b. People with unilateral transtibial amputations for vascular reasons or from traumatic events.
c. At the lowest level of function candidates will have the ability to use a prosthesis for ambulation on level surfaces at a fixed cadence.
d. People with a diagnosis of diabetes mellitus and/or peripheral vascular disease leading to amputation or people who have been amputated as a result of trauma.
e. People comfortably fitted with a prosthesis for a period of at least 6 months.
f. Candidates who score within the range of 29 to 47 on the Amputee Mobility Predictor which would indicate that subjects achieved the minimum required score to be fitted with a prosthesis.
g. Able to tolerate the testing protocol and would not fatigue at any time during testing.
h. Men's shoe size should be between 7.5 (25 cm) and 12.5 (29 cm). i. Women's shoe size should be between 8.5 (25 cm) and 13.5 (29 cm).
Exclusion Criteria:
People who weigh more than 255 pounds at baseline visit. People receiving renal dialysis b. People with severe cardiac or pulmonary disease limiting ability to exercise including angina or poorly controlled hypertension.
c. People with neurological disorder such as or stroke that affecting ability to ambulate d. People with severe lower limb arthritis e. People with wound on non-amputated side f. People experiencing problems with prosthetic fit g. People with poor control of diabetes
Sites / Locations
- Miami VAHS
Arms of the Study
Arm 1
Experimental
Prosthetic Feet
Randomized to 4 different prosthetic feet (SACH, SAFE, TALUX, and Proprio Foot)