Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07075198

Caesar Foot Take-Home Validation Testing

Led by Liberating Technologies, Inc. · Updated on 2025-10-14

18

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

Sponsors

L

Liberating Technologies, Inc.

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Caesar Foot Take-Home Validation Testing

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • Have present or past injuries to residual limb or other leg affecting ability
  • Are non-English speaking due to limited interpreter access
  • Are pregnant
  • May be excluded for other issues like cognitive problems at investigator discretion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hanger Clinic

Austin, Texas, United States, 78758

Actively Recruiting

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Research Team

J

Jennifer Johansson

CONTACT

B

Brianna Rozell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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