No Power Bionic Lower Extremity Prosthesis

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 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)
  • 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 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)

Secondary Measures

  • Net V02 (Metabolic Cost) During Running
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Deanna H Gates, Associate Professor – University of Michigan

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