Prosthetic Foot + Physical Therapy for Leg Amputation

(OPORP Trial)

Overseen By Rebecca L Stine, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Major contralateral amputation, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best combination of prosthetic foot and physical therapy to enhance mobility and satisfaction for individuals who have lost a lower leg. Participants will test various prosthetic feet and select their favorites based on comfort and performance. They will then either continue with regular care or undergo an eight-week personalized physical therapy program using their chosen foot. Suitable candidates for this trial have lost one lower leg below the knee, have used a prosthetic for at least six months, and can walk safely. As an unphased trial, this study allows participants to directly influence future prosthetic and therapy options.

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 this prosthetic foot and physical therapy approach is safe?

Research has shown that using a prosthetic foot with personalized physical therapy is generally safe for individuals who have lost a lower limb. Although specific safety data for using both together is lacking, studies on similar prosthetic devices have demonstrated benefits such as improved walking, increased safety, and enhanced comfort.

The selection of a prosthetic foot depends on what feels best to the user. Participants can choose from several options, often resulting in greater satisfaction and easier movement due to increased comfort with their choice. Additionally, personalized physical therapy aims to improve balance and movement, helping users feel more confident and safe.

Overall, these treatments are well-received and aim to enhance the quality of life for individuals using prosthetic limbs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a personalized approach to prosthetic foot prescriptions combined with targeted physical therapy for individuals with leg amputations. Unlike standard prosthetics, which are often one-size-fits-all, this approach allows participants to experience walking with different prosthetic conditions and choose what works best for them. Additionally, the trial integrates an eight-week personalized physical therapy intervention, which could enhance rehabilitation outcomes beyond traditional methods. This combination aims to improve comfort, mobility, and overall quality of life for amputees, potentially setting a new standard in personalized prosthetic care.

What evidence suggests that this trial's treatments could be effective for improving mobility and satisfaction in individuals with lower limb loss?

Research has shown that customizing prosthetic feet can enhance mobility and satisfaction for individuals with lower limb loss. One study found that a prosthetic foot emulator allows patients to try different prosthetic feet before making a choice, leading to better decisions and outcomes. In this trial, participants will walk with three prosthesis conditions and select their most and least preferred. Past patients have demonstrated significant improvements in movement and balance with personalized foot selection and physical therapy. Another study found that individuals with below-the-knee amputations benefit greatly from specific rehabilitation programs, which enhance their ability to use prosthetics effectively. In this trial, participants will receive either the standard-of-care intervention or an eight-week personalized physical therapy intervention. These findings support tailoring both the prosthetic foot and therapy to individual needs for improved satisfaction and function. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Veterans and others with a single below-knee amputation that happened at least 6 months ago. They must have a well-fitting prosthetic socket and be able to walk safely for the study activities. People with an amputation on the other leg or those currently in physical therapy for walking or prosthesis use can't join.

Inclusion Criteria

My prosthetic socket fits well and works with my limb's internal framework.

I can walk well enough to safely do study tasks.

I have had one lower leg amputated below the knee.

Exclusion Criteria

I have had a major amputation on the limb opposite to the affected one.

I am undergoing physical therapy for walking or using a prosthesis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prosthesis Condition Selection

Participants experience walking with three prosthesis conditions and select their most and least preferred foot

2 weeks

Multiple visits for testing different prosthetic conditions

Accommodation Period

Participants undergo a community-based accommodation period with their most preferred commercial foot

2 weeks

Physical Therapy Intervention

Participants receive either the standard-of-care or an eight-week personalized physical therapy intervention

8 weeks

Regular physical therapy sessions

Follow-up

Participants are monitored for satisfaction, mobility, and balance after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Prosthetic Foot Prescription
• Rehabilitation

Trial Overview

The study tests if choosing a prosthetic foot based on personal preference, followed by targeted physical therapy, improves satisfaction and mobility. Participants will try different prosthetic feet to find their preferred one, then get either standard care or personalized therapy using that foot.

How Is the Trial Designed?

Group I: Prosthesis Condition Experimental Treatment 1 Intervention

Participants experience walking with three prosthesis condition and select their most and least preferred.

Group II: Physical Therapy Active Control 1 Intervention

Participants receive either the standard-of-care intervention (control) or an eight-week personalized physical therapy intervention.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

In a study of 42 patients with dysvascular lower extremity amputation, significant improvements were observed in physical function measures during the prosthetic training phase, including walking distance, gait speed, and timed mobility tasks, all showing statistically significant enhancements (P < .001).

Despite these improvements, patients' gait speed and mobility remained below clinically important thresholds, suggesting ongoing limitations in community ambulation and an increased risk of falls, highlighting the need for tailored rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Outcomes After the Prosthetic Training Phase of Rehabilitation After Dysvascular Lower Extremity Amputation. Christiansen, CL., Fields, T., Lev, G., et al.[2022]

Physical therapists need to understand the different types of prosthetic foot-ankle assemblies, as each type has unique advantages and disadvantages that can affect the management of patients with lower limb amputations.

Prosthetic foot selection should consider the patient's physical abilities, psychological needs, and financial situation, and more research is needed to objectively assess the functionality of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthetic feet. State of the Art. Edelstein, JE.[2022]

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]

In a study involving 10 individuals with unilateral transtibial limb loss, standardized functional prosthetic gait training did not show significant improvements in self-report measures or performance-based tests, except for the Amputee Mobility Predictor (AMPPRO) in those with peripheral vascular disease (PVD).

The Proprio foot demonstrated significant differences in mobility outcomes compared to other prosthetic feet, particularly in the AMPPRO and 6-minute walk test (6MWT), highlighting its potential benefits for users with PVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of self-report and performance-based outcome measures to determine functional differences between four categories of prosthetic feet. Gailey, RS., Gaunaurd, I., Agrawal, V., et al.[2022]

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 involving 10 individuals with unilateral transtibial amputation found that a novel 3D-printed prosthetic foot (ComfyStep) showed significant biomechanical differences compared to conventional prosthetic feet, including reduced range of motion and increased stiffness.

While the 3D-printed foot allows for more individualized adjustments, the differences observed raise questions about its clinical relevance, suggesting that improvements in design, particularly in stiffness, could enhance its performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical comparison of a 3D-printed prosthetic foot with conventional feet in people with transtibial amputation: A prospective cohort study. Trinler, U., Heitzmann, DWW., Hitzeroth, S., et al.[2023]

In a study of 169 patients over 15 years, male gender and transtibial amputation were identified as strong predictors of successful prosthetic rehabilitation, while the presence of ulcers in the preserved limb was linked to rehabilitation failure.

Older age (especially over 65) and comorbidities were significant predictors of failed rehabilitation, highlighting the importance of timely physical therapy for improving walking ability post-amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting successful prosthetic rehabilitation in major lower-limb amputation patients: a 15-year retrospective cohort study. Fajardo-Martos, I., Roda, O., Zambudio-Periago, R., et al.[2022]

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