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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Running | Experimental | Participants will run on an instrumented treadmill at one speed using three different prostheses. |
|
| Sprinting | Experimental | Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otto Bock prosthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomechanics | The investigators will measure stance average vertical ground reaction forces during running and sprinting. | 4-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Demand | The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant. | 4 days |
| Top Speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alena M Grabowski, PhD | VA Eastern Colorado Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder | Boulder | Colorado | 80309 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Biomechanics | The investigators will measure stance average vertical ground reaction forces during running and sprinting. | We hypothesized that prosthetic configurations would affect stance average vertical ground reaction forces. | Posted | Mean | Standard Deviation | N/kg | 4-10 days |
|
1 year
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Jung, DRI Executive Director | Denver Research Institute | 303-501-0540 | Judith.Jung@dri-va.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2014 | Jun 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000673 | Amputation, Traumatic |
| D014947 | Wounds and Injuries |
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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.
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|
| Ossur prosthesis | Device | 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. |
|
| Freedom Innovations prosthesis | Device | 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. |
|
The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.
| 4-10 days |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | m |
|
| Weight | Mean | Standard Deviation | kg |
|
| 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. |
|
|
| 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. | Best metabolic cost for a running-specific prosthetic configuration. | Posted | Mean | Standard Error | Net CoT (J/kg/m) | 4 days |
|
|
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| Secondary | Top Speed | The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant. | Fastest top speed for a running-specific prosthetic configuration. | Posted | Mean | Standard Deviation | m/s | 4-10 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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