Back to resultsNo Power Bionic Lower Extremity Prosthesis
Primary Purpose
Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compliant Adaptive Energy Storage and Return Foot
Conventional Prosthetic Foot
Commercial High Activity Foot
Sponsored by
About this trial
This is an interventional basic science trial for Amputation
Eligibility 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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Conventional Prosthetic Foot
CAESER Prosthetic Foot
Commercial High Activity Foot
Arm Description
In this condition, participants will walk and run with their standard prosthetic feet
In this condition, participants will walk and run with a new prosthesis designed to switch orientation of the foot with a push of a button. They will only wear this device in the lab for an approximately 4 hour period of time
In this condition, participants will run and walk with a commercial foot designed for high activity (AllPro, Fillauer, Chattanooga, TN)
Outcomes
Primary Outcome Measures
Compare Ground reaction force between CAESAR Foot and Conventional foot
Participants will walk and run over sensors that measure the force under their foot
Compare patient preferences between CAESAR Foot and Conventional foot
Participants will be asked their preferences using custom surveys
Secondary Outcome Measures
Compare metabolic cost between CAESAR Foot and Conventional Foot
Participants will wear a mask that measures their rate of oxygen consumption while they run
Full Information
NCT ID
NCT04070105
First Posted
August 20, 2019
Last Updated
January 23, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04070105
Brief Title
No Power Bionic Lower Extremity Prosthesis
Official Title
No Power Bionic Lower Extremity Prosthesis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Prosthetic Foot
Arm Type
Active Comparator
Arm Description
In this condition, participants will walk and run with their standard prosthetic feet
Arm Title
CAESER Prosthetic Foot
Arm Type
Experimental
Arm Description
In this condition, participants will walk and run with a new prosthesis designed to switch orientation of the foot with a push of a button. They will only wear this device in the lab for an approximately 4 hour period of time
Arm Title
Commercial High Activity Foot
Arm Type
Active Comparator
Arm Description
In this condition, participants will run and walk with a commercial foot designed for high activity (AllPro, Fillauer, Chattanooga, TN)
Intervention Type
Device
Intervention Name(s)
Compliant Adaptive Energy Storage and Return Foot
Other Intervention Name(s)
CAESAR Foot
Intervention Description
The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button
Intervention Type
Device
Intervention Name(s)
Conventional Prosthetic Foot
Intervention Description
This is a commercial prosthetic foot that has been prescribed to the individual
Intervention Type
Device
Intervention Name(s)
Commercial High Activity Foot
Intervention Description
This is a commercially available prosthetic foot designed for high-activity individuals
Primary Outcome Measure Information:
Title
Compare Ground reaction force between CAESAR Foot and Conventional foot
Description
Participants will walk and run over sensors that measure the force under their foot
Time Frame
during one lab visit, approximately four hours
Title
Compare patient preferences between CAESAR Foot and Conventional foot
Description
Participants will be asked their preferences using custom surveys
Time Frame
during one lab visit, approximately four hours
Secondary Outcome Measure Information:
Title
Compare metabolic cost between CAESAR Foot and Conventional Foot
Description
Participants will wear a mask that measures their rate of oxygen consumption while they run
Time Frame
during one lab visit, approximately four hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
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No Power Bionic Lower Extremity Prosthesis
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