No Power Bionic Lower Extremity Prosthesis

University of Michigan

Status: Completed

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

Treatments: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro

Study type: Interventional

Funder types: Other

Identifiers

NCT04070105

HUM00150407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 6 patient groups

CAESAR Foot, Prescribed Feet, AllPro

Experimental group

Description:

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

Treatment:

Device: AllPro

Device: Compliant Adaptive Energy Storage and Return Foot

CAESAR Foot, AllPro, Prescribed Feet

Experimental group

Description:

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

Treatment:

Device: AllPro

Device: Compliant Adaptive Energy Storage and Return Foot

Prescribed Feet, AllPro, CAESAR Foot

Experimental group

Description:

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

Treatment:

Device: AllPro

Device: Compliant Adaptive Energy Storage and Return Foot

Prescribed Feet, CAESAR Foot, AllPro

Experimental group

Description:

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

Treatment:

Device: AllPro

Device: Compliant Adaptive Energy Storage and Return Foot

AllPro, Prescribed Feet, CAESAR Foot

Experimental group

Description:

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

Treatment:

Device: AllPro

Device: Compliant Adaptive Energy Storage and Return Foot

AllPro, CAESAR Foot, Prescribed Feet,

Experimental group

Description:

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

Treatment:

Device: AllPro

Device: Compliant Adaptive Energy Storage and Return Foot