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

91 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.

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 data supports the effectiveness of the treatment Articulating ESR Prosthetic Foot, ESR Prosthetic Foot, Powered Prosthetic Foot for lower limb amputation?

Research shows that energy-storing-and-returning (ESR) prosthetic feet can enhance performance compared to older models, and articulating feet can improve ankle motion, although they may reduce push-off power. These advancements aim to mimic natural ankle-foot movement, potentially improving comfort and mobility for users. ^{1 2 3 4 5}

Is the ESR Prosthetic Foot safe for humans?

The research does not provide specific safety data for the ESR Prosthetic Foot, but it discusses the performance and muscle activity effects of these prosthetic feet, suggesting they are generally used in human studies without reported safety concerns. ^{2 3 6 7 8}

How does the treatment for Prosthetic Foot Prescription for Lower Limb Amputation differ from other treatments?

This treatment involves advanced prosthetic feet like Articulating ESR, ESR, and Powered Prosthetic Feet, which aim to mimic human ankle-foot biomechanics more closely than conventional options. These prosthetic feet are designed to store and return energy, potentially improving walking efficiency and comfort compared to older models, although they may not significantly reduce the energy cost of walking. ^{2 4 9 10 11}

Research Team

Jason Maikos, PhD

Principal Investigator

Director, VISN 2 Gait and Motion Analysis Laboratory

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of variables used to assess clinically acceptable alignment of unilateral transtibial amputees in the literature. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Prosthetic feet: state-of-the-art review and the importance of mimicking human ankle-foot biomechanics. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

High-Level Mobility of Trans-Tibial Prosthesis Users Wearing Commercial and sPace Energy-Storing Prosthetic Feet. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Benefits of an increased prosthetic ankle range of motion for individuals with a trans-tibial amputation walking with a new prosthetic foot. [2022]

5. England 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. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Instantaneous stiffness and hysteresis of dynamic elastic response prosthetic feet. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

A Reduced-Order Computational Model of a Semi-Active Variable-Stiffness Foot Prosthesis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effect of prosthetic ankle energy storage and return properties on muscle activity in below-knee amputee walking. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Energy-storing prosthetic feet. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Prescription of prosthetic ankle-foot mechanisms after lower limb amputation. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Prescription options for the below knee amputee. A review. [2022]