Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
|ClinicalTrials.gov Identifier: NCT01404559|
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : December 15, 2014
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Amputation||Device: Ossur Variflex prosthetic foot Device: Ossur Ceterus prosthetic foot Device: Endolite Elite Blade prosthetic foot||Not Applicable|
- 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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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.
- Obstacle Course Completion Time [ Time Frame: 21 days total (7days per prosthetic foot condition) ]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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404559
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||William S Quillen, PT,DPT,PhD||University of South Florida|
|Study Director:||M. Jason Highsmith, PT,DPT,CP||University of South Florida|