Caesar Foot for Below Knee Amputation

Overseen By Brianna Rozell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Liberating Technologies, Inc.

Disqualifiers: Injuries, Non-English speaking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Caesar foot prosthetic in everyday settings for individuals with below-knee amputations. Participants will use their usual prosthetic foot for one month, then switch to the Caesar foot for two months to assess its impact on daily life and activity levels. Feedback will refine the prosthetic for broader use. Ideal candidates have had a below-knee amputation, are interested in running but lack a running blade, and have used their prosthetic for at least six months. As an unphased trial, this study offers participants the opportunity to contribute to the development of a potentially life-enhancing prosthetic.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the Caesar foot is safe for below knee amputation?

Research shows that the Caesar Foot is designed for individuals with a below-knee amputation. Although specific safety data for the Caesar Foot is limited, prosthetic devices like this prioritize user safety and comfort. Studies on prosthetic use highlight the importance of users feeling safe, regardless of their activity level.

The Caesar Foot undergoes testing in real-life situations, with developers closely monitoring its performance and any user issues. This testing aims to ensure the device's safety for everyday use.

While no specific safety issues have been reported for the Caesar Foot, ensuring prosthetic safety remains a top priority during development and testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caesar Foot for below-knee amputations because it promises greater flexibility and adaptability compared to standard prosthetic feet. Unlike traditional options that often provide limited movement, the Caesar Foot is designed to offer enhanced range of motion, potentially improving comfort and functionality for users. This innovation might allow wearers to perform daily activities more naturally and with less effort, which is a significant improvement over conventional prostheses.

What evidence suggests that the Caesar Foot is effective for below knee amputation?

Research has shown that people with lower limb amputations generally prefer energy storing and return (ESAR) prosthetic feet, such as the Caesar Foot, which this trial tests. Studies have found that ESAR feet perform better, and users express greater satisfaction compared to solid ankle cushioned heel (SACH) feet. Users often report that ESAR feet return more energy, making walking feel more natural and less tiring. The Caesar Foot aims to improve mobility and comfort, enhancing quality of life. These benefits are crucial for helping individuals live more active and fulfilling lives after an amputation. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer Johansson

Principal Investigator

Liberating Technologies, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a below-knee amputation, who are at least six months post-amputation and can walk or run well (K3 or K4 ambulator status). They must have a good-fitting prosthetic socket, enough space for the Caesar foot, match one of the Caesar prototypes in size/weight class, and want to run but don't have a running blade.

Inclusion Criteria

My AMP score is 37 or higher.

A certified prosthetist has approved me for running.

My prosthetic socket fits well, as confirmed by a specialist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants wear their usual prosthetic foot for 1 month to collect baseline data

4 weeks

1 visit (in-person)

Experimental Condition

Participants wear the Caesar Foot at home for about 2 months, including running training and acclimation

8 weeks

2-12 visits (in-person) for training

Post-Experimental Condition

Participants wear their usual prosthetic foot for 1 month after completing the experimental condition

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final call to discuss any falls and conduct an exit interview

2 weeks

1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Caesar Foot

Trial Overview The study tests the Caesar Foot prosthesis by having participants use it daily for two months. It compares their experiences with their usual prosthetic foot before and after this period. The goal is to see how well the Caesar Foot works in everyday life through surveys and performance measures.

How Is the Trial Designed?

Group I: Caesar Foot Experimental Treatment 1 Intervention

The participant wears the Caesar Foot at home for about 2 months.

Group II: Usual Prosthesis Pre-Experimental Condition (Baseline) Active Control 1 Intervention

The participant wears their usual prosthetic foot for 1 month before the experimental condition to collect baseline data.

Group III: Usual Prosthesis Post-Experimental Condition Active Control 1 Intervention

The participant wears their usual prosthetic foot for 1 month after completing the experimental condition and after receiving running training.

Who Is Running the Clinical Trial?

Liberating Technologies, Inc.

Lead Sponsor

Trials

13

Recruited

100+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Hanger Clinic: Prosthetics & Orthotics

Collaborator

Trials

11

Recruited

520+

University of Hartford

Collaborator

Trials

15

Recruited

600+

WillowWood

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07075198

NCT07075198 | Caesar Foot Take-Home Validation Testing 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6157252/

Energy storing and return prosthetic feet improve step ... Energy storing and return (ESAR) feet are generally preferred over solid ankle cushioned heel (SACH) feet by people with a lower limb amputation.

3. researchgate.net researchgate.net/figure/The-three-prosthetic-feet-prescribed-in-a-randomized-cross-over-order-for-daily-use-over_fig2_357792393

The three prosthetic feet prescribed in a randomized cross- ... In multiple studies, the ESAR prosthetic foot outperformed the SACH foot [40] . A standard ESAR foot is a viable option for public healthcare [40] , [41], and ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01128-5

Therapeutic benefits of lower limb prostheses: a systematic ... Enhancing the quality of life of people with a lower limb amputation is critical in prosthetic development and rehabilitation.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546594/

Lower Extremity Amputation - StatPearls - NCBI Bookshelf - NIH This activity reviews the evaluation and treatment of patients requiring a lower-extremity amputation and highlights the role of an interprofessional approach.

6. trialx.com trialx.com/clinical-trials/listings/312558/caesar-foot-take-home-validation-testing/

Caesar Foot Take-Home Validation Testing 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9636812/

A review of user needs to drive the development of lower ... The perception of safety while using a prosthesis is reported as the most important need, which is independent of the mobility level of the ...

8. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/pdf/prosthesis-draft-report.pdf

Lower Limb Prosthesis - Effective Health Care Program Assess validity of measures used in adults with lower limb amputation, whether patient characteristics can predict relative effectiveness of different lower ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06161961

Interventional Study on the Evaluation of Functionality ... The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees.

10. nist.gov nist.gov/system/files/documents/2017/04/28/239_limb_prosthetics_services_devices.pdf

Limb Prosthetics Services and Devices A transtibial prosthesis is an artificial limb that replaces a leg missing below the knee. ... However, it is rare for a below- knee amputee ...