N/A N=28 Randomized Triple-blind Treatment

Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities

Amputation

Bottom Line

View on ClinicalTrials.gov: NCT01404559 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Obstacle Course Completion Time — 425; 444; 419; 287 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ossur Variflex prosthetic foot (Device); Ossur Ceterus prosthetic foot (Device); Endolite Elite Blade prosthetic foot (Device)
Age: Adult · 21+ yrs
Sex: Male
Sponsor: University of South Florida
Primary completion: Jun 2013

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	—

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.

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

View full record on ClinicalTrials.gov →

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.