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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.
Specific Aims
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic foot 1 (Ossur Variflex) | Active Comparator | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex). |
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| Prosthetic foot 2 (Ossur Ceterus) | Active Comparator | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus). |
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| Prosthetic foot 3 (Endolite Elite Blade) | Active Comparator | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade). |
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| Non-amputee controls | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ossur Variflex prosthetic foot | Device | Lightweight energy-storing prosthetic foot |
|
| 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) |
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Inclusion Criteria (Amputees):
Inclusion Criteria (Non-amputees)
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| Name | Affiliation | Role |
|---|---|---|
| William S Quillen, PT,DPT,PhD | University of South Florida | Principal Investigator |
| M. Jason Highsmith, PT,DPT,CP | University of South Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prosthetic Foot 1 (Ossur Variflex) | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week). Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ossur Ceterus prosthetic foot | Device | Shock-absorbing prosthetic foot |
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| Endolite Elite Blade prosthetic foot | Device | Multi-axial prosthetic foot |
|
| FG001 |
| Prosthetic Foot 2 (Ossur Ceterus) |
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week). Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot |
| FG002 | Prosthetic Foot 3 (Endolite Elite Blade) | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week). Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot |
| FG003 | 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 intervention. Control group.: There are no interventions in this observational arm of the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transtibial Amputees | This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention. |
| BG001 | 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 intervention. Control group.: There are no interventions in this observational arm of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | 21 days total (7days per prosthetic foot condition) |
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| Primary | 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. | Posted | Mean | Standard Deviation | ml O2/kg/min | 21 days total (7days per prosthetic foot condition) |
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Control subjects were not determined to be at risk given that they were not exposed to an intervention and the activities used to measure performance are routine in their daily work and activities.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unilateral Transtibial Amputees | This arm/group included unilateral transtibial amputees who who were assessed three times. They were exposed to 3 different prosthetic feet interventions. | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William S. Quillen | University of South Florida | 8139749863 | wquillen@health.usf.edu |
| Male |
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| OG003 | 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 intervention. Control group.: There are no interventions in this observational arm of the study. |
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