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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Quillen, University of South Florida
ClinicalTrials.gov Identifier:
NCT01404559
First received: May 31, 2011
Last updated: December 4, 2014
Last verified: December 2014

May 31, 2011
December 4, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
  • Obstacle Course Completion Time [ Time Frame: 21 days total (7days per prosthetic foot condition) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
  • Biomechanics between feet components 21 days after fitting prostheses [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Measures of joint movement and joint forces.
  • Preference between feet components 21 days after fitting prostheses [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Interview and survey to determine which components are preferred by users.
  • Bioenergetics between feet components 21 days after fitting prostheses [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Measures of energy expenditure and perceived exertion.
Complete list of historical versions of study NCT01404559 on ClinicalTrials.gov Archive Site
Not Provided
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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
Metabolic and Biomechanical 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amputation
  • Device: Ossur Variflex prosthetic foot
    Lightweight energy-storing prosthetic foot
  • Device: Ossur Ceterus prosthetic foot
    Shock-absorbing prosthetic foot
  • Device: Endolite Elite Blade prosthetic foot
    Multi-axial prosthetic foot
  • Active Comparator: Prosthetic foot 1 (Ossur Variflex)
    This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex).
    Intervention: Device: Ossur Variflex prosthetic foot
  • Active Comparator: Prosthetic foot 2 (Ossur Ceterus)
    This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus).
    Intervention: Device: Ossur Ceterus prosthetic foot
  • Active Comparator: Prosthetic foot 3 (Endolite Elite Blade)
    This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade).
    Intervention: Device: Endolite Elite Blade prosthetic foot
  • No Intervention: Non-amputee controls
    This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Male
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01404559
10193006
Yes
William Quillen, University of South Florida
University of South Florida
Not Provided
Principal Investigator: William S Quillen, PT,DPT,PhD University of South Florida
Study Director: M. Jason Highsmith, PT,DPT,CP University of South Florida
University of South Florida
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP