An interventional study of Compliant Adaptive Energy Storage and Return Foot and AllPro in Amputation, Amputation, Traumatic and Amputation; Traumatic, Leg, Lower, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by University of Michigan · Not applicable, Interventional, and Basic science
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.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 6 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
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Patient Population:
Inclusion Criteria:
Exclusion Criteria:
Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, Prescribed Feet, AllPro.
Device: Compliant Adaptive Energy Storage and Return Foot · Device: AllPro
Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, AllPro, Prescribed Feet
Device: Compliant Adaptive Energy Storage and Return Foot · Device: AllPro
Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, AllPro, CAESAR Foot
Device: Compliant Adaptive Energy Storage and Return Foot · Device: AllPro
Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, CAESAR Foot, AllPro
Device: Compliant Adaptive Energy Storage and Return Foot · Device: AllPro
Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, Prescribed Feet, CAESAR Foot
Device: Compliant Adaptive Energy Storage and Return Foot · Device: AllPro
Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, CAESAR Foot, Prescribed Feet
Device: Compliant Adaptive Energy Storage and Return Foot · Device: AllPro
The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button
Also known as: CAESAR Foot
Participants will be fit with a high activity foot designed to be used for walking and running
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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: All conditions were complete during 3 lab visits, approximately four hours long
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
Time frame: All conditions were complete during 3 lab visits, approximately four hours long
| Milestone | CAESAR, Then Prescribed, Then AllPro | CAESAR, Then AllPro, Then Prescribed | Prescribed, Then AllPro, Then CAESAR | Prescribed, Then CAESAR, Then AllPro | AllPro, Then CAESAR, Then Prescribed | AllPro, Then Prescribed, Then CAESAR |
|---|---|---|---|---|---|---|
| Started | 0 | 2 | 1 | 1 | 1 | 1 |
| Completed | 0 | 2 | 1 | 1 | 1 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| Body-weights | Prescribed | AllPro | CAESAR |
|---|---|---|---|
| Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking | .175 ± 0.043 | .166 ± 0.022 | .166 ± 0.013 |
Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)
| score on a scale | Prescribed | AllPro | CAESAR |
|---|---|---|---|
| Participants Perceived Comfort When Using Different Prosthetic Feet During Walking | 84.8 ± 11.1 | 80.6 ± 18.7 | 77.4 ± 23.9 |
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.
| Body-weights | Prescribed | AllPro | CAESAR |
|---|---|---|---|
| Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running | 0.093 ± 0.006178 | 0.079 ± 0.005169 | .154 ± 0.004942 |
Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace
| mL/kg/min | Prescribed | AllPro | CAESAR |
|---|---|---|---|
| Net V02 (Metabolic Cost) During Running | 25.66 ± 2.93 | 26.86 ± 2.99 | 27.68 ± 2.52 |
Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)
| score on a scale | Prescribed | AllPro | CAESAR |
|---|---|---|---|
| Participants Perceived Comfort When Using Different Prosthetic Feet During Running | 51.8 ± 27.2 | 59.6 ± 23.3 | 66.4 ± 36.5 |
Collected over During each of the three, approximately 4 hour, data collection sessions. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prosthetic Foot Intervention | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Prosthetic Foot Intervention |
|---|---|
| Mean | 48.7 ± 14.0 |
| Sex: Female, Male(Participants) | Prosthetic Foot Intervention |
|---|---|
| Female | 1 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Prosthetic Foot Intervention |
|---|
| Region of Enrollment(participants) | Prosthetic Foot Intervention |
|---|---|
| United States | 6 |
| Height (m)(meters) | Prosthetic Foot Intervention |
|---|---|
| Mean | 1.75 ± 0.10 |
| Weight (kg)(kg) | Prosthetic Foot Intervention |
|---|---|
| Mean | 80.0 ± 8.3 |
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