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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

August 20, 2019

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed

1 year until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 27, 2024

Completed

Last Updated

March 27, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

August 20, 2019

Results QC Date

January 5, 2024

Last Update Submit

February 29, 2024

Conditions

Amputation Amputation, Traumatic Amputation; Traumatic, Leg, Lower

Outcome Measures

Primary Outcomes (4)

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

Secondary Outcomes (1)

Net V02 (Metabolic Cost) During Running
All conditions were complete during 3 lab visits, approximately four hours long

Study Arms (6)

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.