Caesar Foot Take-Home Validation Testing

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiberating Technologies, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Caesar Foot

Treatment groups

18 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Liberating Technologies, Inc.

Lead sponsor

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

Collaborator

Hanger Clinic: Prosthetics & Orthotics

Collaborator

WillowWood

Collaborator

University of Hartford

Collaborator