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Completed

NCT Number: NCT04070105

No Power Bionic Lower Extremity Prosthesis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compliant Adaptive Energy Storage and Return Foot

Device

The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button

Other names: CAESAR Foot

AllPro

Device

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

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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