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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: February 3, 2014
Last verified: February 2014

May 31, 2011
February 3, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01404559 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 Ceterus prosthetic foot
    Lightweight energy-storing prosthesis.
  • Device: Ossur Variflex prosthetic foot
    Shock-absorbing prosthesis.
  • Device: Freedom Innovations Silhouette VS
    Multi-axial prosthesis.
  • Active Comparator: Prosthetic condition 1
    Subjects are fitted with the first of 3 prostheses which they will test.
    Intervention: Device: Ossur Ceterus prosthetic foot
  • Active Comparator: Prosthetic condition 2
    Subjects are fitted with the second of 3 prostheses which they will test.
    Intervention: Device: Ossur Variflex prosthetic foot
  • Active Comparator: Prosthetic condition 3
    Subjects are fitted with the third of 3 prostheses which they will test.
    Intervention: Device: Freedom Innovations Silhouette VS
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
February 2014

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