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Caesar Foot Take-Home Validation Testing

Liberating Technologies, Inc. · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Hanger Clinic: Prosthetics & Orthotics · NCT07075198

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
18
US sites recruiting
1
Study start
October 2025
Record last updated
October 14, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Caesar Foot

Conditions: Prosthesis User; Lower Limb Amputation Below Knee (Injury)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.).

Recruiting US locations

  • Hanger Clinic

    Austin, TX 78758

    Site contact: Shane Wurdeman, PhD · 402-290-8051 · swurdeman@hanger.com

Study contacts (from the official record)

  • Jennifer Johansson · 774-233-0874 · jen.johansson@liberatingtech.com
  • Brianna Rozell · 774-233-0876 · brianna.rozell@liberatingtech.com
Caesar Foot Take-Home Validation Testing (NCT07075198) | Bored Studies