Skip to main content
OpenTrials
Completed

NCT Number: NCT01404559

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amputation

Age range

21 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ossur Variflex prosthetic foot

Device

Lightweight energy-storing prosthetic foot

Ossur Ceterus prosthetic foot

Device

Shock-absorbing prosthetic foot

Endolite Elite Blade prosthetic foot

Device

Multi-axial prosthetic foot

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 28, 2011
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.