No Power Bionic Lower Extremity Prosthesis

Not Applicable

Completed

• Conditions: Amputation; Traumatic, Leg, Lower; Amputation, Traumatic; Amputation
• Interventions: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro

• Registration Number: NCT04070105
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2020-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Results First Submitted: 2024-01-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Results First Posted: 2024-03-27
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

• Significant injury to intact limb
• History of balance impairments or neurologic disorders
• Significant cardiovascular or respiratory disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CAESAR Foot, Prescribed Feet, AllPro	Compliant Adaptive Energy Storage and Return Foot	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, Prescribed Feet, AllPro.
CAESAR Foot, AllPro, Prescribed Feet	Compliant Adaptive Energy Storage and Return Foot	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, AllPro, Prescribed Feet
Prescribed Feet, CAESAR Foot, AllPro	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
CAESAR Foot, Prescribed Feet, AllPro	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.
Prescribed Feet, AllPro, CAESAR Foot	Compliant Adaptive Energy Storage and Return 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
Prescribed Feet, AllPro, CAESAR Foot	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
CAESAR Foot, AllPro, Prescribed Feet	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
Prescribed Feet, CAESAR Foot, AllPro	Compliant Adaptive Energy Storage and Return Foot	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, CAESAR Foot, AllPro
AllPro, CAESAR Foot, Prescribed Feet,	Compliant Adaptive Energy Storage and Return Foot	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, CAESAR Foot, Prescribed Feet
AllPro, Prescribed Feet, CAESAR Foot	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
AllPro, CAESAR Foot, Prescribed Feet,	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
AllPro, Prescribed Feet, CAESAR Foot	Compliant Adaptive Energy Storage and Return 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

Primary Outcome Measures

Name	Time	Method
Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking	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	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	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	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)

Secondary Outcome Measures

Name	Time	Method
Net V02 (Metabolic Cost) During Running	All conditions were complete during 3 lab visits, approximately four hours long	Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States