Caesar Foot Take-Home Validation Testing

NCT07075198 | Recruiting

• 2 other identifiers: 138751R44HD113432-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Prosthetic Limb Users Survey of Mobility (PLUS-M)

  The version of the PLUS-M being administered consists of 22 questions. Each question asks about their ability to ambulate in certain instances and at certain speeds, and is scored on a scale of 1 (unable to do) to 5 (without any difficulty). A higher score indicates a better outcome. This survey will be given at the end of each study condition. Since the first month of the Caesar condition will be for training and acclimation, the PLUS-M will be given after the second month that the participant is in the experimental condition.

  1 month

Study Arms (3)

Usual Prosthesis Pre-Experimental Condition (Baseline)

NO INTERVENTION

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

Caesar Foot

EXPERIMENTAL

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

Device: Caesar Foot

Usual Prosthesis Post-Experimental Condition

NO INTERVENTION

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

Interventions

Caesar Foot DEVICE

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.

Caesar Foot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.).

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Hanger Clinic: Prosthetics & Orthotics: collaborator
• WillowWood: collaborator
• University of Hartford: collaborator

Study Sites (1)

Hanger Clinic

Austin, Texas, 78758, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jennifer Johansson

  Liberating Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Johansson

CONTACT

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

Brianna Rozell

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)