Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
NCT ID: NCT01404559
Last Updated: 2014-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2012-07-31
2013-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Prosthetic foot 1 (Ossur Variflex)
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex).
Ossur Variflex prosthetic foot
Lightweight energy-storing prosthetic foot
Prosthetic foot 2 (Ossur Ceterus)
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus).
Ossur Ceterus prosthetic foot
Shock-absorbing prosthetic foot
Prosthetic foot 3 (Endolite Elite Blade)
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade).
Endolite Elite Blade prosthetic foot
Multi-axial prosthetic foot
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.
No interventions assigned to this group
Interventions
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Ossur Variflex prosthetic foot
Lightweight energy-storing prosthetic foot
Ossur Ceterus prosthetic foot
Shock-absorbing prosthetic foot
Endolite Elite Blade prosthetic foot
Multi-axial prosthetic foot
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
45 Years
MALE
Yes
Sponsors
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University of South Florida
OTHER
Responsible Party
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William Quillen
Associate Dean & Professor
Principal Investigators
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William S Quillen, PT,DPT,PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
M. Jason Highsmith, PT,DPT,CP
Role: STUDY_DIRECTOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Other Identifiers
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10193006
Identifier Type: -
Identifier Source: org_study_id