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
  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 Variflex prosthetic foot
Device: Ossur Ceterus prosthetic foot
Device: Endolite Elite Blade prosthetic foot

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:
  • 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.


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 foot 1 (Ossur Variflex)
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex).
Device: Ossur Variflex prosthetic foot
Lightweight energy-storing 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).
Device: Ossur Ceterus prosthetic foot
Shock-absorbing 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).
Device: Endolite Elite Blade prosthetic foot
Multi-axial 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: November 17, 2014
Last Updated: December 4, 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 September 02, 2015