N/A
Completed N=28
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Amputation
Source: ClinicalTrials.gov NCT01404559 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Obstacle Course Completion Time — 425; 444; 419; 287 seconds
Summary
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Obstacle Course Completion Time |
425; 444; 419; 287 | — |
| PRIMARY Bioenergetics Between Feet Components 21 Days After Fitting Prostheses |
15.7; 15.57; 15.05; 11.05 | — |
Eligibility Criteria
Inclusion Criteria (Amputees):
- Unilateral transtibial amputee ambulating on a K4 prosthesis for >1yr
- K4 functional level
- Currently active duty military or other uniformed service (e.g. police), recently separated Veteran, or strong high-performance athletic history as an amputee (e.g. ranked triathlete, paralympian, etc.)
- Schedule availability and willingness to comply with study protocols
- Aged < 45 years
- Medical clearance, within the last 6 months, for participation in vigorous physical activities
Inclusion Criteria (Non-amputees)
- Currently active duty military, ROTC, or other uniformed service (e.g. police) or recently separated Veteran, or highly accomplished recreational athlete (e.g. marathoner)
- Schedule availability and willingness to comply with study protocols
- Aged < 45 years
- Medical clearance, within the last 6 months, for participation in vigorous physical activities
Data sourced from ClinicalTrials.gov (NCT01404559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.