Amputation
Conditions
Keywords
Amputee, Transtibial, Military, Gait, Rehabilitation
Brief summary
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.
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.
Interventions
DEVICEOssur Variflex prosthetic foot
Lightweight energy-storing prosthetic foot
DEVICEOssur Ceterus prosthetic foot
Shock-absorbing prosthetic foot
DEVICEEndolite Elite Blade prosthetic foot
Multi-axial prosthetic foot
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obstacle Course Completion Time | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transtibial Amputees This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention. | 14 |
| 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. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Transtibial Amputees | Non-amputee Controls | Total |
|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 5.9 | 38.5 years STANDARD_DEVIATION 5.1 | 33.2 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: 21 days total (7days per prosthetic foot condition)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prosthetic Foot 1 (Ossur Variflex) | Bioenergetics Between Feet Components 21 Days After Fitting Prostheses | 15.7 ml O2/kg/min | Standard Deviation 2.29 |
| Prosthetic Foot 2 (Ossur Ceterus) | Bioenergetics Between Feet Components 21 Days After Fitting Prostheses | 15.57 ml O2/kg/min | Standard Deviation 2.26 |
| Prosthetic Foot 3 (Endolite Elite Blade) | Bioenergetics Between Feet Components 21 Days After Fitting Prostheses | 15.05 ml O2/kg/min | Standard Deviation 2.17 |
| Non-amputee Controls | Bioenergetics Between Feet Components 21 Days After Fitting Prostheses | 11.05 ml O2/kg/min | Standard Deviation 1.89 |
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.
Time frame: 21 days total (7days per prosthetic foot condition)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prosthetic Foot 1 (Ossur Variflex) | Obstacle Course Completion Time | 425 seconds | Standard Deviation 144 |
| Prosthetic Foot 2 (Ossur Ceterus) | Obstacle Course Completion Time | 444 seconds | Standard Deviation 220 |
| Prosthetic Foot 3 (Endolite Elite Blade) | Obstacle Course Completion Time | 419 seconds | Standard Deviation 130 |
| Non-amputee Controls | Obstacle Course Completion Time | 287 seconds | Standard Deviation 58 |