No Power Bionic Lower Extremity Prosthesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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No Power Bionic Lower Extremity Prosthesis

Conditions
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Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower

Intervention / Treatment
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* Device: Compliant Adaptive Energy Storage and Return Foot
* Device: Conventional Prosthetic Foot
* Device: Commercial High Activity Foot


Participation Criteria
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Eligibility Criteria
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Patient Population: Inclusion Criteria: At least 18 years old Transtibial amputation of one or both legs Classified as K3 or K4 on the Medicare Functional Classification Level Use of a well-fitting prosthetic socket and prosthetic foot for at least 6 months Able to walk and run without assistance Exclusion Criteria: Significant injury to intact limb History of balance impairments or neurologic disorders Significant cardiovascular or respiratory disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Prosthetic Foot<br>In this condition, participants will walk and run with their standard prosthetic feet | Device: Conventional Prosthetic Foot<br>* This is a commercial prosthetic foot that has been prescribed to the individual<br>|
| Experimental: CAESER Prosthetic Foot<br>In this condition, participants will walk and run with a new prosthesis designed to switch orientation of the foot with a push of a button. They will only wear this device in the lab for an approximately 4 hour period of time | Device: Compliant Adaptive Energy Storage and Return Foot<br>* The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button<br>* Other names: CAESAR Foot;|
| Active Comparator: Commercial High Activity Foot<br>In this condition, participants will run and walk with a commercial foot designed for high activity (AllPro, Fillauer, Chattanooga, TN) | Device: Commercial High Activity Foot<br>* This is a commercially available prosthetic foot designed for high-activity individuals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Ground reaction force between CAESAR Foot and Conventional foot | Participants will walk and run over sensors that measure the force under their foot | during one lab visit, approximately four hours | 
| Compare patient preferences between CAESAR Foot and Conventional foot | Participants will be asked their preferences using custom surveys | during one lab visit, approximately four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare metabolic cost between CAESAR Foot and Conventional Foot | Participants will wear a mask that measures their rate of oxygen consumption while they run | during one lab visit, approximately four hours |