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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Caesar Foot
DeviceThe 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.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Usual Prosthesis Pre-Experimental Condition (Baseline)No intervention 0 interventions
Group B: Caesar FootExperimental treatment 1 intervention
Group C: Usual Prosthesis Post-Experimental ConditionNo intervention 0 interventions
Trial outcomes
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.
Time frame
1 monthSponsors and contacts
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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
Source ClinicalTrials.gov