Try the Caesar take-home foot for everyday use and running
Caesar Foot Take-Home Validation Testing
This trial tests whether people with below‑knee amputations who are interested in running can use the bimodal Caesar foot at home for two months to see if it improves mobility and daily activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Liberating Technologies, Inc. Industry-sponsored |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT07075198 on ClinicalTrials.gov |
What this trial studies
Participants will complete a one‑month baseline period using their usual prosthetic foot, then take the Caesar foot home for two months, followed by a one‑month return to their usual foot. Outcomes include the Prosthetic Limb Users Survey of Mobility (PLUS‑M) as the primary measure, plus exploratory self‑report measures (PROMIS, TAPES‑R, EQ‑5D, PLUS‑F) and performance tests such as the 10‑Meter Walk Test, gait speeds, and a timed quarter‑mile. Surveys will be collected on a HIPAA‑compliant platform or paper if needed, and performance measures will be taken in clinic visits at the end of each condition. The study is sponsored by Liberating Technologies with collaborators including NICHD, Hanger Clinic, and WillowWood, and is conducted at Hanger Clinic in Austin, Texas.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) at least six months post‑transtibial amputation who are K3 or K4 ambulators, have an AMP score ≥37, are interested in running but do not yet use a running blade, have a well‑fitting socket and adequate residual limb clearance, and fit the prototype size/weight classes.
Not a fit: Patients who are lower‑activity (K1/K2), have recent injuries or other conditions limiting function, poor socket fit, inadequate clearance, or who cannot attend clinic visits (including non‑English speakers for this protocol) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the Caesar foot could help active below‑knee amputees increase mobility and confidence for walking and running in everyday life.
How similar studies have performed: Related bimodal and running prosthetic feet have shown positive results in controlled settings, but take‑home, real‑world validation of this specific device is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 limb and ground for the Caesar foot * Meets the foot size and weight class of one of the available Caesar prototypes Exclusion Criteria: * 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. Individuals can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).
Where this trial is running
Austin, Texas
- Hanger Clinic — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Johansson — Liberating Technologies, Inc.
- Study coordinator: Jennifer Johansson
- Email: jen.johansson@liberatingtech.com
- Phone: 774-233-0874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.