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Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.
Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active. Here we will test this device to determine how it affects the user's mechanics during running and walking. Participants will come to a research laboratory for three test sessions where they will run and walk in their current foot, a commercial high-activity foot, and the prototype CAESAR foot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAESAR Foot, Prescribed Feet, AllPro | Experimental | Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, Prescribed Feet, AllPro. |
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| CAESAR Foot, AllPro, Prescribed Feet | Experimental | Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, AllPro, Prescribed Feet |
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| Prescribed Feet, AllPro, CAESAR Foot | Experimental | Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, AllPro, CAESAR Foot |
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| Prescribed Feet, CAESAR Foot, AllPro | Experimental | Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, CAESAR Foot, AllPro |
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| AllPro, Prescribed Feet, CAESAR Foot |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compliant Adaptive Energy Storage and Return Foot | Device | The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking | Participants will walk over sensors that measure the force under their foot. Peak ground reaction force in the anterior direction is measured in Newtons and then divided by the individual's body weight (BW). The resultant force is measured in Body-weights. | All conditions were complete during 3 lab visits, approximately four hours long |
| Participants Perceived Comfort When Using Different Prosthetic Feet During Walking | Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable) | All conditions were complete during 3 lab visits, approximately four hours long |
| Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running | Participants will run on a treadmill with force sensors below the treadmill belt. Data will be measured in Newtons and then normalized by dividing by body weight. | All conditions were complete during 3 lab visits, approximately four hours long |
| Participants Perceived Comfort When Using Different Prosthetic Feet During Running | Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable) | All conditions were complete during 3 lab visits, approximately four hours long |
| Measure | Description | Time Frame |
|---|---|---|
| Net V02 (Metabolic Cost) During Running | Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace | All conditions were complete during 3 lab visits, approximately four hours long |
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Patient Population:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Participants enrolled in the study and tested a prototype foot to assess stiffness. A foot was then manufactured for them specifically. Due to COVID19 pauses in collection there was a significant gap between manufacturing the prosthetic feet and human subjects testing. One participant was no longer available to complete laboratory testing. The order of testing was randomized between participants, such that all participants completed testing in a different order.
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| ID | Title | Description |
|---|---|---|
| FG000 | CAESAR, Then Prescribed, Then AllPro | Participants will walk and run with three prostheses in random order |
| FG001 | CAESAR, Then AllPro, Then Prescribed | Participants will walk and run with three prostheses in random order |
| FG002 | Prescribed, Then AllPro, Then CAESAR | Participants will walk and run with three prostheses in random order |
| FG003 | Prescribed, Then CAESAR, Then AllPro | Participants will walk and run with three prostheses in random order |
| FG004 | AllPro, Then CAESAR, Then Prescribed | Participants will walk and run with three prostheses in random order |
| FG005 | AllPro, Then Prescribed, Then CAESAR | Participants will walk and run with three prostheses in random order |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prosthetic Foot Intervention | Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN) Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button Conventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual Commercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals |
| 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 |
| 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 | Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking | Participants will walk over sensors that measure the force under their foot. Peak ground reaction force in the anterior direction is measured in Newtons and then divided by the individual's body weight (BW). The resultant force is measured in Body-weights. | Participants walked with each of three feet: prescribed, CAESAR, and AllPro | Posted | Mean | Standard Deviation | Body-weights | All conditions were complete during 3 lab visits, approximately four hours long |
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During each of the three, approximately 4 hour, data collection sessions
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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 | Prosthetic Foot Intervention | Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN) Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button Conventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual Commercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals |
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Six participants were enrolled and we built six feet for those individuals. Due to delays because of COVID pauses in human subjects testing, only five were available to test the final foot design. Of these, only three were able to run on a treadmill comfortably for five minutes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deanna Gates | University of Michigan | 7346472698 | gatesd@umich.edu |
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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 | Jan 5, 2024 | Jan 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000673 | Amputation, Traumatic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot
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Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, Prescribed Feet, CAESAR Foot |
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| AllPro, CAESAR Foot, Prescribed Feet, | Experimental | Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, CAESAR Foot, Prescribed Feet |
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| AllPro | Device | Participants will be fit with a high activity foot designed to be used for walking and running |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height (m) | Mean | Standard Deviation | meters |
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| Weight (kg) | Mean | Standard Deviation | kg |
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This is a commercially available prosthetic foot designed for high-activity individuals
| OG002 | CAESAR | Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button |
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| Primary | Participants Perceived Comfort When Using Different Prosthetic Feet During Walking | Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable) | Posted | Mean | Standard Deviation | score on a scale | All conditions were complete during 3 lab visits, approximately four hours long |
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| Primary | Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running | Participants will run on a treadmill with force sensors below the treadmill belt. Data will be measured in Newtons and then normalized by dividing by body weight. | Participants ran with each of three feet: prescribed, CAESAR, and AllPro | Posted | Mean | Standard Deviation | Body-weights | All conditions were complete during 3 lab visits, approximately four hours long |
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| Secondary | Net V02 (Metabolic Cost) During Running | Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace | Participants who could run comfortably on the treadmill for 5 minutes with that foot | Posted | Mean | Standard Deviation | mL/kg/min | All conditions were complete during 3 lab visits, approximately four hours long |
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| Primary | Participants Perceived Comfort When Using Different Prosthetic Feet During Running | Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable) | Participants who ran in the lab with each foot style. One participant did not complete the survey with his prescribed foot | Posted | Mean | Standard Deviation | score on a scale | All conditions were complete during 3 lab visits, approximately four hours long |
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