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

Not Applicable
Completed
Conditions
Amputation
Interventions
Device: Endolite Elite Blade prosthetic foot
Device: Ossur Ceterus prosthetic foot
Device: Ossur Variflex prosthetic foot
Registration Number
NCT01404559
Lead Sponsor
University of South Florida
Brief 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.

Detailed Description

Specific Aims

* Compare the effectiveness of popular prostheses for improving performance in physically demanding tasks and environments.

* Compare amputee performance to a group of high-functioning non-amputees to determine performance differences between the groups.

Hypotheses:

Prosthetic feet with shock absorbing and torsional features will perform better in field activities. Prosthetic feet with high energy return and low mass will perform better during treadmill running. Non-amputee controls will demonstrate superior performance in all outcomes in both field and laboratory environments compared to amputee subjects.

Relevance:

This study has the potential to quantify differences between highly mobile amputees and non-amputees. Additionally, it will provide objective measures of how different prostheses may enhance mobility of soldiers with amputations. The study will compare laboratory and field measures to indicate which conditions increase efficiency of prostheses during rapidly changing mobility demands. This has the potential to permit retention of already trained soldiers.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
28
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Prosthetic foot 3 (Endolite Elite Blade)Endolite Elite Blade prosthetic footThis arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade).
Prosthetic foot 2 (Ossur Ceterus)Ossur Ceterus prosthetic footThis arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus).
Prosthetic foot 1 (Ossur Variflex)Ossur Variflex prosthetic footThis arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex).
Primary Outcome Measures
NameTimeMethod
Obstacle Course Completion Time21 days total (7days per prosthetic foot condition)

Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.

Bioenergetics Between Feet Components 21 Days After Fitting Prostheses21 days total (7days per prosthetic foot condition)

Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of South Florida

🇺🇸

Tampa, Florida, United States

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