- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070105
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
6
Phase
- 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
- Name: Deanna Gates, PhD
- Phone Number: 734-647-5514
- Email: gatesd@umich.edu
Study Contact Backup
- Name: Jordan Kartes, BS
- Phone Number: 734-647-5514
- Email: kartesj@umich.edu
Study Locations
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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:
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
|
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:
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
|
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:
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
|
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:
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
|
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:
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
|
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:
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
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
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
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)
September 1, 2020
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 23, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
February 29, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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