RecruitingNot ApplicableNCT07075198

Caesar Foot Take-Home Validation Testing

Sponsor

Liberating Technologies, Inc.

Enrollment

18 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee (Injury)Prosthesis User

Summary

The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment. Participants will take the device home and use it throughout their daily life for two months. A one-month baseline period, using their usual foot, will be completed both before and after the two-month period with the Caesar foot condition. Self-report surveys and performance-based measures will be collected in the clinic at the end of each condition. The intent of this study is to determine the Caesar foot's feasibility in a real-world environment. Data will be collected to understand impact to the user's daily life and physical activity through outcomes and participant feedback. The feedback obtained during this study will be essential to informing the design intended for commercialization.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

Have transtibial limb absence of one or both limbs
Express interest in running, but do not currently have a running blade (as determined by self-report)
Are at least 18 years of age
Are at least six months post amputation
Are classified as K3 or K4 ambulator status as determined by a certified prosthetist
Have an AMP score of at least 37
Are capable of running safely as determined by a certified prosthetist's clinical judgement
Have a well-fitting socket as determined by a certified prosthetist
Have adequate clearance between distal end of the residual limb and ground for the Caesar foot
Meets the foot size and weight class of one of the available Caesar prototypes

Exclusion Criteria4

Present or sustained injuries to residual limb or contralateral leg affecting functional ability
Non-English speaking participants will be excluded from this study due to limited access to interpreter services. These services would be needed for several visits, including training to learn how to use the device safely, along with requested verbal feedback from the participant to evaluate the design and usability of the system.
Using a prosthetic foot that an individual is unfamiliar with for higher activity tasks may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.
Individuals can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).

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Interventions

DEVICECaesar Foot

The investigators developed a bimodal, passive mechanical prosthetic foot called the Caesar Foot. The Caesar Foot has two modes: one optimized for walking, and one optimized for higher-energy activities like running. It has a switching device that was designed such that when it switches modes, it inherently accounts for the alignment and stiffness differences between walking and running feet (such as the longer length, higher stiffness, and different ground contact points required for running feet). Therefore, it should be largely comparable to a daily use prosthesis / walking foot when in walking mode, and an running specific prosthesis / running blade when in running mode. This foot is attached and aligned to the user's usual prosthetic socket.