AmputationNCT04070105

No Power Bionic Lower Extremity Prosthesis

A study testing Compliant Adaptive Energy Storage and Return Foot and AllPro in people with Amputation and Amputation, Traumatic, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
What is being tested?: Compliant Adaptive Energy Storage and Return Foot and AllPro
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 31 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Significant injury to intact limb
History of balance impairments or neurologic disorders
Significant cardiovascular or respiratory disease

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Read the 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.

Conditions: Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
Being tested: Compliant Adaptive Energy Storage and Return Foot, AllPro
Medical subject headings: Amputation, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Compliant Adaptive Energy Storage and Return FootDevice
Also called 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
AllProDevice
Participants will be fit with a high activity foot designed to be used for walking and running

Study groups in NCT04070105
Study group	Role	What they receive
CAESAR Foot, Prescribed Feet, AllPro	Experimental	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, Prescribed Feet, AllPro. Receives: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro
CAESAR Foot, AllPro, Prescribed Feet	Experimental	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, AllPro, Prescribed Feet Receives: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro
Prescribed Feet, AllPro, CAESAR Foot	Experimental	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, AllPro, CAESAR Foot Receives: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro
Prescribed Feet, CAESAR Foot, AllPro	Experimental	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, CAESAR Foot, AllPro Receives: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro
AllPro, Prescribed Feet, CAESAR Foot	Experimental	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, Prescribed Feet, CAESAR Foot Receives: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro
AllPro, CAESAR Foot, Prescribed Feet,	Experimental	Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, CAESAR Foot, Prescribed Feet Receives: Device: Compliant Adaptive Energy Storage and Return Foot; Device: AllPro

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking
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.
Measured: All conditions were complete during 3 lab visits, approximately four hours long
Participants Perceived Comfort When Using Different Prosthetic Feet During Walking
Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)
Measured: All conditions were complete during 3 lab visits, approximately four hours long
Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running
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.
Measured: All conditions were complete during 3 lab visits, approximately four hours long
Participants Perceived Comfort When Using Different Prosthetic Feet During Running
Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)
Measured: All conditions were complete during 3 lab visits, approximately four hours long

Secondary outcomes (1)

Net V02 (Metabolic Cost) During Running
Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace
Measured: All conditions were complete during 3 lab visits, approximately four hours long

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202031 Dec 2022

First posted28 Aug 2019
Study start1 Sep 2020
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AmputationStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
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)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04070105
Sponsor's protocol ID: HUM00150407
Status last verified: Feb 2024
First submitted: 20 Aug 2019
Last updated: 27 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Impact of Footwear on Gait in Unilateral Transtibial Amputees
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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
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All Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: No Power Bionic Lower Extremity Prosthesis
ClinicalTrials.gov ID: NCT04070105
Acronym / sponsor ID: HUM00150407
Conditions: Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 28 Aug 2019 (actual)
Results: Posted 27 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot

Arm	Type	Receives
CAESAR Foot, Prescribed Feet, AllPro	Experimental	Device: Compliant Adaptive Energy Storage and Return Foot, Device: AllProParticipants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, Prescribed Feet, AllPro.
CAESAR Foot, AllPro, Prescribed Feet	Experimental	Device: Compliant Adaptive Energy Storage and Return Foot, Device: AllProParticipants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, AllPro, Prescribed Feet
Prescribed Feet, AllPro, CAESAR Foot	Experimental	Device: Compliant Adaptive Energy Storage and Return Foot, Device: AllProParticipants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, AllPro, CAESAR Foot
Prescribed Feet, CAESAR Foot, AllPro	Experimental	Device: Compliant Adaptive Energy Storage and Return Foot, Device: AllProParticipants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, CAESAR Foot, AllPro
AllPro, Prescribed Feet, CAESAR Foot	Experimental	Device: Compliant Adaptive Energy Storage and Return Foot, Device: AllProParticipants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, Prescribed Feet, CAESAR Foot
AllPro, CAESAR Foot, Prescribed Feet,	Experimental	Device: Compliant Adaptive Energy Storage and Return Foot, Device: AllProParticipants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, CAESAR Foot, Prescribed Feet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

Significant injury to intact limb
History of balance impairments or neurologic disorders
Significant cardiovascular or respiratory disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Compliant Adaptive Energy Storage and Return FootAlso: CAESAR FootThe 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, CAESAR Foot, Prescribed Feet,, AllPro, Prescribed Feet, CAESAR Foot, CAESAR Foot, AllPro, Prescribed Feet, CAESAR Foot, Prescribed Feet, AllPro, Prescribed Feet, AllPro, CAESAR Foot, Prescribed Feet, CAESAR Foot, AllPro
AllProParticipants will be fit with a high activity foot designed to be used for walking and running	Device	AllPro, CAESAR Foot, Prescribed Feet,, AllPro, Prescribed Feet, CAESAR Foot, CAESAR Foot, AllPro, Prescribed Feet, CAESAR Foot, Prescribed Feet, AllPro, Prescribed Feet, AllPro, CAESAR Foot, Prescribed Feet, CAESAR Foot, AllPro

Primary outcome

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)

1 secondary outcome

Net V02 (Metabolic Cost) During Running
Time frame: All conditions were complete during 3 lab visits, approximately four hours long

Results and safety

Results posted to the registry on 27 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAESAR, Then Prescribed, Then AllPro	0	0
CAESAR, Then AllPro, Then Prescribed	2	2
Prescribed, Then AllPro, Then CAESAR	1	1
Prescribed, Then CAESAR, Then AllPro	1	1
AllPro, Then CAESAR, Then Prescribed	1	1
AllPro, Then Prescribed, Then CAESAR	1	0

Primary outcome: 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. Mean (Standard Deviation). Unit: Body-weights

Measure	Prescribed n = 5	AllPro n = 5	CAESAR n = 5
Value	.175 (0.043)	.166 (0.022)	.166 (0.013)

Population analysed: Participants walked with each of three feet: prescribed, CAESAR, and AllPro

Primary outcome: Participants Perceived Comfort When Using Different Prosthetic Feet During Walking

Time frame: All conditions were complete during 3 lab visits, approximately four hours long. Mean (Standard Deviation). Unit: score on a scale

Measure	Prescribed n = 5	AllPro n = 5	CAESAR n = 5
Value	84.8 (11.1)	80.6 (18.7)	77.4 (23.9)

Primary outcome: 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. Mean (Standard Deviation). Unit: Body-weights

Measure	Prescribed n = 3	AllPro n = 2	CAESAR n = 3
Value	0.093 (0.006178)	0.079 (0.005169)	.154 (0.004942)

Population analysed: Participants ran with each of three feet: prescribed, CAESAR, and AllPro

Primary outcome: Participants Perceived Comfort When Using Different Prosthetic Feet During Running

Time frame: All conditions were complete during 3 lab visits, approximately four hours long. Mean (Standard Deviation). Unit: score on a scale

Measure	Prescribed n = 4	AllPro n = 5	CAESAR n = 5
Value	51.8 (27.2)	59.6 (23.3)	66.4 (36.5)

Population analysed: Participants who ran in the lab with each foot style. One participant did not complete the survey with his prescribed foot

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During each of the three, approximately 4 hour, data collection sessions. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prosthetic Foot Intervention	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): Six participants were enrolled and we built six feet for those individuals. Due to delays because of COVID pauses in human subjects testing, only five were available to test the final foot design. Of these, only three were able to run on a treadmill comfortably for five minutes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Amputation

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Compliant Adaptive Energy Storage and Return Foot and AllPro in people with Amputation and Amputation, Traumatic, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04070105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.