Actively Recruiting
Caesar Foot Take-Home Validation Testing for Prosthesis Users with Below-Knee Amputation
Led by Liberating Technologies, Inc. · Updated on 2025-10-14
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Liberating Technologies, Inc.
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of the bimodal Caesar Foot, a prosthetic device designed for both walking and running, in a real-world setting. This study focuses on users with transtibial limb absence who are interested in running but do not currently have a running blade. The purpose is to assess the feasibility and user experience of the Caesar Foot through performance and self-report measures over multiple conditions. The study follows a pilot longitudinal comparative effectiveness design with a sequence of baseline, experimental, and post-experimental periods. Participants will go through three main conditions: first, wearing their usual prosthetic foot for one month as a baseline; second, using the Caesar Foot at home for about two months, including a running training program led by physical therapists; and third, returning to their usual foot for one month after the experimental period. The Caesar Foot has two modes optimized for walking and running, with alignment and stiffness adjustments. Training sessions will help participants learn to run safely and competently with the new foot. During the study, participants will attend five site visits and complete various self-report surveys and performance-based tests, including the Prosthetic Limb Users Survey of Mobility (PLUS-M), walking and running speed tests, and activity monitoring with step counts and fall tracking. Periodic check-in calls will monitor participant progress and address concerns. Data collected will provide insights into mobility, fatigue, social participation, and prosthesis experience, helping improve future designs. The entire participation lasts about four months with at-home and clinic-based assessments.
CONDITIONS
Brief Title
Caesar Foot Take-Home Validation Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have transtibial limb absence of one or both limbs
- Express interest in running but do not currently have a running blade
- 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 limb and ground for the Caesar foot
- Meet the foot size and weight class of one of the available Caesar prototypes
You will not qualify if you...
- Present or sustained injuries to residual limb or contralateral leg affecting functional ability
- Non-English speaking participants due to limited interpreter services
- Pregnant women (screened by self-disclosure)
- Other disqualifying criteria as determined by investigator, such as cognitive issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
5 site visits
Duration - 1 month
Participants wear their usual prosthetic foot at home to collect baseline data for 1 month before trying the Caesar Foot.
At-home wear with monitoring and periodic check-in calls
Duration - Approximately 2 months
Participants wear the Caesar Foot at home for about 2 months, including a running training program with 2 to 12 one-hour sessions to learn and demonstrate running competency.
Wearing the foot at home with activity monitoring, periodic calls, and 2 to 12 training sessions
Duration - 1 month
Participants return to wearing their usual prosthetic foot at home for 1 month after completing the experimental condition and running training.
At-home wear with monitoring and periodic check-in calls
Duration - Shortly after final visit
A final call with the study team to review any falls, clarify survey data, and complete the exit interview and preference survey.
1 phone call
Trial Site Locations
Total: 1 location
1
Hanger Clinic
Austin, Texas, United States, 78758
Actively Recruiting
Research Team
J
Jennifer Johansson
B
Brianna Rozell
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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