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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Ossur Variflex prosthetic foot; Device: Ossur Ceterus prosthetic foot; Device: Endolite Elite Blade prosthetic foot

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstacle Course Completion Time	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.	21 days total (7days per prosthetic foot condition)
Bioenergetics Between Feet Components 21 Days After Fitting Prostheses	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.	21 days total (7days per prosthetic foot condition)

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (ESTIMATE): July 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 15, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait; Military; Amputee; Transtibial
• Other Study ID Numbers: 10193006