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Clinical Trials/NCT01404559
NCT01404559
Completed
Not Applicable

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

University of South Florida1 site in 1 country28 target enrollmentJuly 2012
ConditionsAmputation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation
Sponsor
University of South Florida
Enrollment
28
Locations
1
Primary Endpoint
Obstacle Course Completion Time
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
June 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Quillen

Associate Dean & Professor

University of South Florida

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Obstacle Course Completion Time

Time Frame: 21 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 Prostheses

Time Frame: 21 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.

Study Sites (1)

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