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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of clinical trial is to assess an integrated, patient-centered strategy combining user preference-based prosthetic foot prescription and subsequent targeted physical therapy to maximize satisfaction and mobility outcomes for Veterans and others with lower limb loss. The main aims it will address are: * Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction * Assess the effect of a targeted physical therapy intervention following preference-based foot selection on mobility, balance, and satisfaction? Participants will walk with an emulator prosthetic foot to experience three different conditions that emulate different commercial feet to determine their most- and least-preferred foot. Participants' satisfaction, perceived mobility, and functional mobility will be measured and compared between their most- and least-preferred feet using the corresponding commercial feet. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized physical therapy intervention for eight weeks using that preferred prosthetic foot. Participants' satisfaction, mobility, and balance will be measured pre- and post-intervention.

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 Personalized Prosthetic Foot Prescription and Rehabilitation for leg amputation?

Research shows that using tests like the six-minute walk test can help predict how well someone will do with a prosthetic leg, and training with different prosthetic feet can improve mobility, especially for those with certain health conditions. ^{1 2 3 4 5}

Is the combination of a prosthetic foot and physical therapy safe for people with leg amputations?

The research does not provide specific safety data for the combination of a prosthetic foot and physical therapy, but it discusses the use of prosthetic feet in rehabilitation, which is a common and generally safe practice for people with leg amputations. ^{3 6 7 8 9}

How is the Personalized Prosthetic Foot Prescription treatment different from other treatments for leg amputation?

The Personalized Prosthetic Foot Prescription is unique because it involves customizing the prosthetic foot to match the individual's lifestyle and functional needs, which can include adjustable and sophisticated designs. This personalized approach ensures that the prosthetic foot is well-suited to the patient's specific requirements, unlike standard prosthetic options that may not offer such tailored adjustments. ^{5 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Predicting successful prosthetic rehabilitation in major lower-limb amputation patients: a 15-year retrospective cohort study. [2022]

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

Factors Associated With Prolonged Length of Stay and Failed Lower Limb Prosthetic Fitting During Inpatient Rehabilitation. [2022]

3. 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]

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

Application of self-report and performance-based outcome measures to determine functional differences between four categories of prosthetic feet. [2022]

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

Functional Outcomes After the Prosthetic Training Phase of Rehabilitation After Dysvascular Lower Extremity Amputation. [2022]

6. 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]

7. France 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. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Characterization of initial ankle-foot prosthesis prescription patterns in U.S. Service members following unilateral transtibial amputation. [2023]

9. France pubmed.ncbi.nlm.nih.gov

Comparing forefoot and heel stiffnesses across commercial prosthetic feet manufactured for individuals with varying body weights and foot sizes. [2023]

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

The latest designs in prosthetic feet. [2007]

11. England pubmed.ncbi.nlm.nih.gov

Early fitting of artificial limbs to amputated lower limbs. [2022]

12. England pubmed.ncbi.nlm.nih.gov

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

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

Prosthetic feet. State of the Art. [2022]