Amputation, Traumatic, Traumatic Amputation of Lower Extremity, Wounds and Injuries
Conditions
Brief summary
The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.
Interventions
DEVICEOtto Bock prosthesis
Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
DEVICEOssur prosthesis
Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
DEVICEFreedom Innovations prosthesis
Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
Sponsors
United States Department of Defense
VA Eastern Colorado Health Care System
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at one speed and we measured metabolic rates and biomechanics. 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at multiple speeds and we measured top speeds and biomechanics.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* bilateral or unilateral transtibial amputation * at least one year of running experience using running-specific prostheses * 18-55 years old * no current problems with their prosthesis or residual limb * at a K4 Medicare Functional Classification Level
Exclusion criteria
* Cardiovascular, pulmonary, or neurological disease or disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanics | 4-10 days | The investigators will measure stance average vertical ground reaction forces during running and sprinting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Demand | 4 days | The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant. |
| Top Speed | 4-10 days | The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Running Participants will run on an instrumented treadmill at one speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter. | 15 |
| Sprinting Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed using different prostheses.
Participants will run using the Otto Bock, Ossur and Freedom Innovations prostheses at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Running | Total | Sprinting |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 30 Participants | 15 Participants |
| Age, Continuous | 33.4 years STANDARD_DEVIATION 6.1 | 30 years STANDARD_DEVIATION 6.1 | 28 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 29 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 1.77 m STANDARD_DEVIATION 0.08 | 1.77 m STANDARD_DEVIATION 0.12 | 1.77 m STANDARD_DEVIATION 0.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 21 Participants | 10 Participants |
| Region of Enrollment United States | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
| Weight | 76.1 kg STANDARD_DEVIATION 14.1 | 76.1 kg STANDARD_DEVIATION 14.1 | 76 kg STANDARD_DEVIATION 12.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Biomechanics
The investigators will measure stance average vertical ground reaction forces during running and sprinting.
Time frame: 4-10 days
Population: We hypothesized that prosthetic configurations would affect stance average vertical ground reaction forces.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Running | Biomechanics | 0.1386 N/kg | Standard Deviation 0.0031 |
| Sprinting | Biomechanics | 0.1835 N/kg | Standard Deviation 0.0204 |
Secondary
Metabolic Demand
The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.
Time frame: 4 days
Population: Best metabolic cost for a running-specific prosthetic configuration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Running | Metabolic Demand | 3.82 Net CoT (J/kg/m) | Standard Error 1.5 |
| Sprinting | Metabolic Demand | 3.38 Net CoT (J/kg/m) | Standard Error 1 |
Secondary
Top Speed
The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.
Time frame: 4-10 days
Population: Fastest top speed for a running-specific prosthetic configuration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Running | Top Speed | 8.18 m/s | Standard Deviation 1 |
| Sprinting | Top Speed | 9.42 m/s | Standard Deviation 0.9 |