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Search / Trial NCT07075198

Caesar Foot Take-Home Validation Testing

Launched by LIBERATING TECHNOLOGIES, INC. · Jul 10, 2025

Trial Information

Current as of August 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new type of prosthetic foot called the Caesar foot, designed for people who have had a below-the-knee amputation. The goal is to see how well this foot works in everyday life, especially for those interested in running but who don’t currently use a running-specific prosthetic foot. Participants will first use their regular prosthetic foot for one month, then take the Caesar foot home and use it daily for two months, and finally go back to their regular foot for another month. Researchers will check in at the clinic after each period to gather feedback and test how the foot affects daily activities and physical performance.

To be eligible, participants need to be at least 18 years old, have had a below-knee amputation for at least six months, and be classified as having moderate to high mobility by a prosthetist (a specialist who fits prosthetic limbs). They should be interested in running and able to run safely, have a good-fitting socket (the part of the prosthesis that attaches to the leg), and meet certain size and weight requirements for the Caesar foot. People with injuries that affect walking or running, non-English speakers, and pregnant women cannot join the study. Those who take part can expect to try the new foot in their daily routines and share their experiences to help improve the design before it becomes widely available.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.).

About Liberating Technologies, Inc.

Liberating Technologies, Inc. is an innovative clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through the development of cutting-edge technologies. Focused on enhancing the quality of life for individuals with mobility challenges, the company leverages its expertise in robotics and rehabilitation to design and implement clinical trials that evaluate the efficacy and safety of novel therapeutic solutions. With a commitment to collaboration and transparency, Liberating Technologies aims to foster partnerships with healthcare professionals, researchers, and regulatory bodies, ensuring that their studies are conducted with the highest standards of integrity and scientific rigor.

Locations

Patients applied

0 patients applied

Trial Officials

Jennifer Johansson

Principal Investigator

Liberating Technologies, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported