Caesar Foot Take-Home Validation Testing
Liberating Technologies, Inc.
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.
Description
In this study, the investigators will administer a suite of performance-based and self-report measures to assess demonstrated and perceived differences between the foot conditions. The primary measure for this study is the Prosthetic Limb Users Survey of Mobility (PLUS-M). The investigators hypothesize that the participants will have greater mobility as reported by the PLUS-M in the Caesar foot as compared to their usual walking foot. There are many aspects of mobility and activity that may not be captured by a single assessment. Therefore, the investigators will examine additional explorator…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 li…
Interventions
- DeviceCaesar 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.
Location
- Hanger ClinicAustin, Texas