Prosthetic Foot Prescription for Lower Limb Amputation

Overseen By Michael Hyre, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA New York Harbor Healthcare System

Disqualifiers: Active wounds, Rapid limb changes, Overweight, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best prosthetic foot options for Veterans and Service Members who have lost a leg below the knee. The research aims to match various prosthetic feet, such as those that store and release energy (ESR Prosthetic Foot) or have powered movement (Powered Prosthetic Foot), to the user's daily needs and goals. Participants will try different prosthetic feet and select the one that best suits their lifestyle. This trial suits individuals with a well-fitting prosthetic who have lost one leg below the knee and can move independently. As an unphased trial, it offers participants the chance to directly influence the development of prosthetic technology tailored to their unique needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these prosthetic feet are safe for Veterans and Service Members with transtibial limb loss?

Research has shown that various types of prosthetic feet, such as articulating ESR, ESR, and powered prosthetic feet, have undergone safety testing in multiple studies. However, specific safety details for these types are not always available.

For the articulating ESR prosthetic foot, studies have primarily examined performance rather than direct safety outcomes. Research indicates that these prosthetic feet are as strong and durable as steel.

Studies on the ESR prosthetic foot also emphasize performance, with limited safety information available. These feet are designed to help users walk more naturally and regain function.

Some research on powered prosthetic feet highlights benefits like reducing knee and back pain, suggesting they can improve overall well-being. However, detailed safety information is not extensively covered.

Overall, these prosthetic feet are generally considered safe, with no major safety issues reported in available studies. While direct safety data is limited, the emphasis on performance and user benefits suggests they are safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of innovative prosthetic technologies to enhance mobility and comfort for individuals with lower limb amputations. Unlike traditional prosthetic feet, these new options include articulating ESR, ESR, and powered prosthetic feet, each designed to mimic natural foot movement and improve energy return. The articulating ESR foot adds flexibility for varied terrain, while the powered foot offers propulsion, making walking less tiring. By allowing participants to test each type and choose their preferred option, the trial aims to provide insights into user satisfaction and functional benefits, potentially guiding future prosthetic designs.

What evidence suggests that this trial's prosthetic feet could be effective for transtibial limb loss?

This trial will compare different prosthetic foot options for individuals with lower limb amputation. Research has shown that the ESR prosthetic foot, which can bend and move, reduces stress on the remaining leg by about 13.1%, potentially lowering the risk of long-term injuries. Studies also indicate that the ESR foot, which stores and releases energy, improves mobility for those with lower limb loss. Participants in this trial may use the ESR prosthetic foot, the articulating ESR prosthetic foot, or the powered prosthetic foot. For those using powered prosthetic feet, research has found they significantly reduce knee pain and improve overall quality of life. Overall, active and semi-active prosthetic feet, like powered ones, are preferred over non-moving feet for better movement and performance. These findings support the potential benefits of these prosthetic options for people with below-knee limb loss. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason Maikos, PhD

Principal Investigator

Director, VISN 2 Gait and Motion Analysis Laboratory

Are You a Good Fit for This Trial?

This trial is for Veterans, Service Members, or civilians with one lower leg amputated who can move around independently and have a well-fitting prosthetic foot. They must be able to attend all research visits and not have vision loss that affects walking, rapid limb volume changes due to conditions like kidney disease on dialysis, active wounds on the remaining leg, cognitive issues affecting study participation, an upper limb amputation or weigh over 275 pounds.

Inclusion Criteria

Has a minimum clearance of 8 ¾ inches to accommodate all feet

I am a veteran, service member, or civilian with one below-knee amputation.

I can move around with little to no help.

Exclusion Criteria

Is unable or unwilling to comply with all research visits

Poorly fitting socket

Vision loss that requires use of an assistive device for gait

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will use different types of prosthetic feet, starting with one type each week for 3 weeks, followed by 4 weeks where they can self-select the foot type for daily activities

7 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Articulating ESR Prosthetic Foot
• ESR Prosthetic Foot
• Powered Prosthetic Foot

Trial Overview The study aims to establish criteria for prescribing different types of prosthetic feet: non-articulating ESR (Energy Storing and Returning), articulating ESR, and powered prosthetic feet. It will test which type best enhances overall function by correlating patient goals with objective data from functional outcome tests.

How Is the Trial Designed?

Group I: ESR Prosthetic Foot First Active Control 1 Intervention

Subject will start with an energy storing and returning (ESR) prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot, and a powered prosthetic foot for 1 week. During the final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Group II: Articulating ESR Prosthetic Foot First Active Control 1 Intervention

Subjects will start with an Articulating ESR prosthetic foot first for 1 week, then will complete an additional week with the ESR prosthetic foot, and a powered prosthetic foot for 1 week.The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.

Group III: Powered Prosthetic Foot First Active Control 1 Intervention

Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot and an ESR prosthetic foot for 1 week. The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.

Who Is Running the Clinical Trial?

VA New York Harbor Healthcare System

Lead Sponsor

Trials

25

Recruited

14,400+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

James A. Haley Veterans Administration Hospital

Collaborator

Trials

21

Recruited

13,200+

VA Puget Sound Health Care System

Collaborator

Trials

67

Recruited

225,000+

Published Research Related to This Trial

The study reviewed 25 articles involving 253 adults with transtibial amputations to identify variables that assess clinically acceptable prosthetic alignment, highlighting that most studies focused on standing position rather than walking.

Key sensitive outcomes for evaluating prosthetic alignment quality included joint angles and load line locations in standing, while during walking, the forces and timing of gait events were crucial, suggesting that both standing and walking assessments are important for optimal alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of variables used to assess clinically acceptable alignment of unilateral transtibial amputees in the literature. Tafti, N., Hemmati, F., Safari, R., et al.[2018]

A study of 120 unilateral transtibial prosthesis users found that the six-minute walk test (6MWT) and one-leg standing test on prosthesis (OLSTP) can effectively predict the functional K-level of patients, which is crucial for appropriate prosthesis prescription.

Using a simple classification rule based on 6MWT results, the study achieved nearly 90% sensitivity and specificity in distinguishing between different K-levels, suggesting these tests could enhance clinical decision-making in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing K-levels and prescribing transtibial prostheses using six-minute walk test and one-leg standing test on prosthesis: a retrospective audit. Majdič, N., Vidmar, G., Burger, H.[2022]

Citations

1. withpower.com withpower.com/trial/prosthetic-foot-prescription-for-lower-limb-amputation-f5a51

Prosthetic Foot Prescription for Lower Limb Amputation The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131701/

Criteria for Advanced Prosthetic Foot Prescription This study aims to develop evidence-based guidelines for limb loss care teams for the appropriate prescription of commercially available prosthetic ankle-foot ...

3. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2023.1235693/full

Characterization of initial ankle-foot prosthesis prescription ... Use of a lower limb prosthesis improves the quality of life and mobility for individuals with lower limb loss (5). Yet, while prosthetic device ...

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

Therapeutic benefits of lower limb prostheses: a systematic ... Results indicate that quasi-passive and active prostheses are favoured over passive prostheses based on biomechanical, physiological, performance and ...

5. nature.com nature.com/articles/s41598-022-09114-y

Biomechanical evaluation over level ground walking of ... Similarly, peak limb loading and flexion moment on the intact leg were reduced by an average of 13.1%, lowering risk of long-term injuries. LLTE ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06938087

Assessment of Safety and Performances of a 3D Printed ... The secondary objectives aims at evaluate usability and deformation of the 3D printed prosthesis under different loading conditions (slow and fast walking, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9566704/

High-Level Mobility of Trans-Tibial Prosthesis Users ... Participants using the sPace foot were capable of performing walking, high-level mobility and activity outcome measures.

8. researchgate.net researchgate.net/publication/394926843_A_Novel_Design_of_the_Articulated_Lower_Limb_Prosthetic_Foot_Using_Fiber-Reinforced_Polymer

A Novel Design of the Articulated Lower Limb Prosthetic ... The numerical results showed that the induced stresses and strains in the prosthetic foot give a similar factor of safety as steel but with a ...

9. journals.sagepub.com journals.sagepub.com/doi/pdf/10.1177/09544119241295342?download=true

A systematic review of energy storing dynamic response ... The prosthetic foot, as an integrated module of each lower extremity prosthesis primarily restores an ampu- tee's functional capabilities and gait pattern.8,15 ...