No Power Bionic Lower Extremity Prosthesis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04070105

Enrollment

Registered

2019-08-28

Start date

2020-09-01

Completion date

2022-12-31

Last updated

2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower

Brief summary

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.

Interventions

DEVICECompliant 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

DEVICEAllPro

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking	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	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	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	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

Measure	Time frame	Description
Net V02 (Metabolic Cost) During Running	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

Countries

United States

Participant flow

Pre-assignment details

Participants enrolled in the study and tested a prototype foot to assess stiffness. A foot was then manufactured for them specifically. Due to COVID19 pauses in collection there was a significant gap between manufacturing the prosthetic feet and human subjects testing. One participant was no longer available to complete laboratory testing. The order of testing was randomized between participants, such that all participants completed testing in a different order.

Participants by arm

Arm	Count
Prosthetic Foot Intervention Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN) 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 Conventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual Commercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals	6
Total	6

Arm

Count

Prosthetic Foot Intervention

Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN) 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 Conventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual Commercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals

Total

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Lost to Follow-up	0	0	0	0	0	1

Baseline characteristics

Characteristic	Prosthetic Foot Intervention	—
Age, Continuous	48.7 years STANDARD_DEVIATION 14	—
Height (m)	1.75 meters STANDARD_DEVIATION 0.1	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	6 participants	—
Sex: Female, Male Female	1 Participants	—
Sex: Female, Male Male	5 Participants	—
Weight (kg)	80.0 kg STANDARD_DEVIATION 8.3	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 6
other Total, other adverse events	0 / 6
serious Total, serious adverse events	0 / 6

Outcome results

Primary

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)