Caesar Foot Take-Home Validation Testing

Part of paid clinical trials in Austin, Texas.

Sponsor
Liberating Technologies, Inc.
Study ID
NCT07075198
Status
Recruiting
Apply to this trial

Conditions

  • Lower Limb Amputation Below Knee (Injury)
  • Prosthesis User

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual Prosthesis Pre-Experimental Condition (Baseline)
    The participant wears their usual prosthetic foot for 1 month before the experimental condition to collect baseline data.
  • Experimental: Caesar Foot
    The participant wears the Caesar Foot at home for about 2 months.
  • No Intervention: Usual Prosthesis Post-Experimental Condition
    The participant wears their usual prosthetic foot for 1 month after completing the experimental condition and after receiving running training.

Primary Outcome Measure

Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hanger ClinicAustinTexas78758
Shane Wurdeman, PhD
[email protected]
402-290-8051
Todd Castleberry
[email protected]
(512) 284-1337

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By research site
Hanger Clinic· Austin, TX

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