Caesar Foot Take-Home Validation Testing

Recruiting now · Not applicable

Conditions studied: Prosthesis User, Lower Limb Amputation Below Knee (Injury)

In brief

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.

Key facts

Study ID

NCT07075198

Run by

Liberating Technologies, Inc.

People needed

18

Starts

2025-10-01

Expected to finish

2026-08-01

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.).

Where it is running

• Hanger Clinic — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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