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
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