No Power Bionic Lower Extremity Prosthesis

University of Michigan1 site in 1 country6 target enrollmentSeptember 1, 2020

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2020

End Date

December 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Deanna H Gates

Associate Professor

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking

Time Frame: All conditions were complete during 3 lab visits, approximately four hours long

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 Perceived Comfort When Using Different Prosthetic Feet During Running

Time Frame: All conditions were complete during 3 lab visits, approximately four hours long

Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)

Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running

Time Frame: All conditions were complete during 3 lab visits, approximately four hours long

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 Perceived Comfort When Using Different Prosthetic Feet During Walking

Time Frame: All conditions were complete during 3 lab visits, approximately four hours long

Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)