No Power Bionic Lower Extremity Prosthesis

February 29, 2024 updated by: Deanna H Gates, University of Michigan
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Other Names:
  • CAESAR Foot
Device: AllPro
Participants will be fit with a high activity foot designed to be used for walking and running
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
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
Other Names:
  • CAESAR Foot
Device: AllPro
Participants will be fit with a high activity foot designed to be used for walking and running
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
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
Other Names:
  • CAESAR Foot
Device: AllPro
Participants will be fit with a high activity foot designed to be used for walking and running
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
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
Other Names:
  • CAESAR Foot
Device: AllPro
Participants will be fit with a high activity foot designed to be used for walking and running
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
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
Other Names:
  • CAESAR Foot
Device: AllPro
Participants will be fit with a high activity foot designed to be used for walking and running
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
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
Other Names:
  • CAESAR Foot
Device: AllPro
Participants will be fit with a high activity foot designed to be used for walking and running

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
All conditions were complete during 3 lab visits, approximately four hours long
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)
All conditions were complete during 3 lab visits, approximately four hours long
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.
All conditions were complete during 3 lab visits, approximately four hours long
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)
All conditions were complete during 3 lab visits, approximately four hours long

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
All conditions were complete during 3 lab visits, approximately four hours long

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00150407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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