Slope Adaptive Foot for Amputation

Overseen By Mary E Matsumoto, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Skin problems, Not regular user, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prosthetic foot called the Fillauer Slope Adaptive Foot (SAF). It aims to help veterans with below-knee amputations walk more effectively on sloped or uneven surfaces, enhancing mobility and reducing fall risks. Participants will try both the SAF and a typical hydraulic foot to determine which works better for them. The trial seeks U.S. military veterans with a below-knee amputation who have used a prosthesis comfortably for at least a year and can walk in the community without limits. As an unphased trial, this study offers veterans the chance to explore innovative prosthetic technology that could enhance their daily mobility.

Will I have to stop taking my current medications?

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

What prior data suggests that the Slope Adaptive Foot is safe for veterans with below-knee amputations?

Research has shown that slope-adaptive prosthetic feet, such as the Fillauer Slope Adaptive Foot (SAF), can improve walking on sloped surfaces. Studies have found that these feet may enhance safety by increasing the gap between the toe and the ground, helping to prevent trips and falls. This suggests that the SAF is a suitable option for individuals with below-knee amputations. Additionally, initial testing with Veterans received positive feedback, indicating possible improvements in daily activities and confidence.

Although specific safety details for the SAF are not provided, its design focuses on enhancing movement and safety, which are promising signs of its suitability. It is important to consult healthcare providers to understand the potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Fillauer Slope Adaptive Foot (SAF) is unique because it adapts to uneven terrain, providing a more natural walking experience for amputees. Unlike standard prosthetic feet, which may struggle on slopes or uneven surfaces, the SAF adjusts its angle to match the ground, enhancing stability and comfort. Researchers are excited about this innovation as it could significantly improve mobility and quality of life for users by allowing them to navigate a wider range of environments with ease.

What evidence suggests that the Slope Adaptive Foot is effective for improving mobility in veterans with below-knee amputations?

Research shows that the Fillauer Slope Adaptive Foot (SAF) can help people with below-knee amputations move better. Studies have found that the SAF adjusts to sloped and uneven ground, making walking smoother and more stable. This feature may lower the risk of falls and boost confidence in walking. Early results suggest that SAF users have better balance and gain more energy with each step, reducing the effort needed for walking. In this trial, participants will experience both the SAF and the SLX in a cross-over design to compare their effects. Overall, these benefits might lead to greater involvement in everyday activities and hobbies. ^{1 6 7 8 9}

Who Is on the Research Team?

Sara Koehler-McNicholas, PhD MS BS

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Mary E Matsumoto, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

This trial is for veterans with below-knee amputations. Participants should be able to walk independently with a prosthesis and commit to the study's duration. Specific criteria may apply, but key exclusions haven't been provided.

Inclusion Criteria

Well-fitting and well-aligned prosthesis

Uses a prescribed energy storage and return foot (ESAR)

Blessed Orientation-Memory-Concentration (Short Blessed) test score between 0-6 (no cognitive impairment)

Exclusion Criteria

I have skin issues on my amputated limb.

Not a regular prosthesis user

Mass over 125 kg (275 lbs)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-over Randomized Controlled Trial

Participants undergo a cross-over RCT with the Slope Adaptive Foot (SAF) and typical hydraulic foot (SLX), each for a 4-week take-home period, separated by a 4-week washout period.

12 weeks

3 visits (in-person)

Observational Study

Participants use their preferred prosthetic foot for a one-year observational study, with quarterly assessments.

52 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the observational study.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fillauer Slope Adaptive Foot

Trial Overview The study tests a new Slope Adaptive Foot (SAF) against a typical hydraulic foot, Fillauer Motion Foot SLX, in a cross-over randomized controlled trial. It aims to see if SAF improves participation in daily activities and reduces fall risks for veterans.

How Is the Trial Designed?

Group I: SLX-SAF Experimental Treatment 2 Interventions

Participants in this arm will start the cross-over randomized controlled trial with the SLX. After a four-week take-home period with the SLX, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SAF for a four-week take-home period.

Group II: SAF-SLX Experimental Treatment 2 Interventions

Participants in this arm will start the cross-over randomized controlled trial with the SAF. After a four-week take-home period with the SAF, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SLX for a four-week take-home period.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07266077

Influence Of A Slope Adaptive Foot On Participation ... This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11271739/

The effects of slope-adaptive prosthetic feet on sloped gait ... Outcomes included biomechanical variables (joint dynamics, gait symmetry, toe clearance), clinical outcome measures, and energy expenditure. All SAF ...

3. trial.medpath.com trial.medpath.com/clinical-trial/25778f08c7727adb/nct07266077-slope-adaptive-foot-veterans-lower-limb-amputations

Influence Of A Slope Adaptive Foot On Participation ... - MedPath This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0021929019304798

Subject-specific responses to an adaptive ankle prosthesis ... The objective of this study was to characterize how the slope adaptation feature of a microprocessor-controlled ankle affected individual ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/0309364613481489?icid=int.sj-abstract.citing-articles.17

Energetic consequences of using a prosthesis with ... The device uses accelerometer data to determine the orientation and motion of the leg and then adapt device performance with the end goal of ...

6. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-017-0322-2

Standing on slopes – how current microprocessor-controlled ... It was the aim of the study to investigate to what extent these commercially available microprocessor-controlled prosthetic feet support a natural posture ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/20556683221101623

OASIS 2: Mobility differences with specific prosthetic feet ... The purpose of this analysis was to compare patient-reported functional mobility across a range of prosthetic feet using real-world clinical ...

8. researchgate.net researchgate.net/figure/Ankle-angle-adaptations-in-the-prosthetic-feet-to-upward-and-downward-slopes-a-Ankle_fig5_321112851

Ankle angle adaptations in the prosthetic feet to upward ... At the vertical shank angle during slope descent, TTA demonstrated a behavior of the ankle moment similar to able-bodied controls when using the MPF.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39055064/

The effects of slope-adaptive prosthetic feet on sloped gait ... Slope-adaptive prosthetic feet may improve user gait quality and comfort and enhance gait safety by increasing minimum toe clearance.