Recruiting

Caesar Foot

Sponsor:

Liberating Technologies, Inc.

Code:

NCT07075198

Conditions

Prosthesis User

Lower Limb Amputation Below Knee (Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Caesar Foot

Study Details

Brief 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.

Conditions

Prosthesis User

Lower Limb Amputation Below Knee (Injury)

Study ID

NCT07075198

Start date

Oct, 2025

Status verified date

Oct, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.).

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual Prosthesis Pre-Experimental Condition (Baseline)

The participant wears their usual prosthetic foot for 1 month before the experimental condition to collect baseline data.

experimental: Caesar Foot

The participant wears the Caesar Foot at home for about 2 months.

no intervention: Usual Prosthesis Post-Experimental Condition

The participant wears their usual prosthetic foot for 1 month after completing the experimental condition and after receiving running training.

Interventions

Caesar 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.

Primary outcome measure

  • Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Jennifer Johansson

774-233-0874jen.johansson@liberatingtech.com

Brianna Rozell

774-233-0876brianna.rozell@liberatingtech.com

Locations

Hanger Clinic

Recruiting

Austin, Texas, United States, 78758

Contacts

Shane Wurdeman, PhD

402-290-8051swurdeman@hanger.com

Todd Castleberry

(512) 284-1337tcastleberry@hanger.com

More Information

Sponsor

Liberating Technologies, Inc.

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Liberating Technologies, Inc. on 2025-10-14.