No Power Bionic Lower Extremity Prosthesis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Amputation Amputation, Traumatic Amputation; Traumatic, Leg, Lower

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CAESAR Foot, Prescribed Feet, AllPro

Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, Prescribed Feet, AllPro.

Group Type EXPERIMENTAL

Compliant Adaptive Energy Storage and Return Foot

Intervention Type 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

AllPro

Intervention Type DEVICE

Participants will be fit with a high activity foot designed to be used for walking and running

CAESAR Foot, AllPro, Prescribed Feet

Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, AllPro, Prescribed Feet

Group Type EXPERIMENTAL

Compliant Adaptive Energy Storage and Return Foot

Intervention Type 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

AllPro

Intervention Type DEVICE

Participants will be fit with a high activity foot designed to be used for walking and running

Prescribed Feet, AllPro, CAESAR Foot

Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, AllPro, CAESAR Foot

Group Type EXPERIMENTAL

Compliant Adaptive Energy Storage and Return Foot

Intervention Type 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

AllPro

Intervention Type DEVICE

Participants will be fit with a high activity foot designed to be used for walking and running

Prescribed Feet, CAESAR Foot, 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

Group Type EXPERIMENTAL

Compliant Adaptive Energy Storage and Return Foot

Intervention Type 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

AllPro

Intervention Type DEVICE

Participants will be fit with a high activity foot designed to be used for walking and running

AllPro, Prescribed Feet, CAESAR Foot

Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, Prescribed Feet, CAESAR Foot

Group Type EXPERIMENTAL

Compliant Adaptive Energy Storage and Return Foot

Intervention Type 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

AllPro

Intervention Type DEVICE

Participants will be fit with a high activity foot designed to be used for walking and running

AllPro, CAESAR Foot, Prescribed Feet,

Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, CAESAR Foot, Prescribed Feet

Group Type EXPERIMENTAL

Compliant Adaptive Energy Storage and Return Foot

Intervention Type 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

AllPro

Intervention Type DEVICE

Participants will be fit with a high activity foot designed to be used for walking and running

Interventions

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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

Intervention Type DEVICE

AllPro

Participants will be fit with a high activity foot designed to be used for walking and running

Intervention Type DEVICE

Other Intervention Names

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CAESAR Foot

Eligibility Criteria

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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