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
  Purpose

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.


Condition Intervention
Amputation
Device: Ossur Ceterus prosthetic foot
Device: Ossur Variflex prosthetic foot
Device: Freedom Innovations Silhouette VS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prosthetic condition 1
Subjects are fitted with the first of 3 prostheses which they will test.
Device: Ossur Ceterus prosthetic foot
Lightweight energy-storing prosthesis.
Active Comparator: Prosthetic condition 2
Subjects are fitted with the second of 3 prostheses which they will test.
Device: Ossur Variflex prosthetic foot
Shock-absorbing prosthesis.
Active Comparator: Prosthetic condition 3
Subjects are fitted with the third of 3 prostheses which they will test.
Device: Freedom Innovations Silhouette VS
Multi-axial prosthesis.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404559

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: William S Quillen, PT,DPT,PhD University of South Florida
Study Director: M. Jason Highsmith, PT,DPT,CP University of South Florida
  More Information

No publications provided

Responsible Party: William Quillen, Associate Dean & Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01404559     History of Changes
Other Study ID Numbers: 10193006
Study First Received: May 31, 2011
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Amputee
Transtibial
Military
Gait
Rehabilitation

ClinicalTrials.gov processed this record on April 17, 2014