Prosthetic Foot Stiffness Modulation for Below Knee Amputation
(ABC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGlenn Klute, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Seattle Institute for Biomedical and Clinical Research

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to identify prosthesis stiffness that optimizes balance control in individuals with below knee amputations. The main question this clinical trial will answer is: • Is there an optimal stiffness that improves balance control for specific ambulatory activities and users? Participants will wear a novel prosthesis assembled with three prosthetic feet with a range of stiffness levels: each individual's clinically-prescribed foot stiffness and ± two stiffness categories. While wearing the study prostheses, participants will perform nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain).

Eligibility Criteria

This trial is for individuals with below knee amputations. Participants should be able to perform daily activities and must not have any additional conditions that could affect balance or require a specific prosthesis stiffness outside the study's range.

Inclusion Criteria

It has been over a year since my amputation.

I can walk on a treadmill.

I have had one leg amputated below the knee.

+2 more

Exclusion Criteria

I have a condition other than amputation that affects my ability to walk.

I have skin irritation or injury on my amputated limb.

I use a device like a cane or walker to help me walk.

Participant Groups

The trial tests how different levels of prosthetic foot stiffness impact balance during everyday activities. It compares the person's usual foot stiffness with two variations: one stiffer and one less stiff, across nine common tasks.

9Treatment groups

Experimental Treatment

Group I: Walking up an 8% slope at self-selected speedExperimental Treatment3 Interventions

All participants will walk on a treadmill, in a straight line, up an 8% slope, at their self-selected walking speed determined while walking overground up an 8% slope.

Group II: Walking on uneven terrain at self-selected speedExperimental Treatment3 Interventions

All participants will walk on an uneven terrain treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking on the uneven terrain treadmill.

Group III: Walking on 0% slope at self-selected speed while hand carrying a 5 kg load on their prosthetic sideExperimental Treatment3 Interventions

All participants will walk on a treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking overground, while carrying a 5 kg load in one hand on their prosthetic side.

Group IV: Walking on 0% slope at self-selected speedExperimental Treatment3 Interventions

All participants will walk on a treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking overground.

Group V: Walking on 0% slope at 15% slower than self-selected speedExperimental Treatment3 Interventions

All participants will walk on a treadmill, in a straight line, on a 0% slope, at a speed that is 15% slower than their self-selected walking speed determined while walking overground.

Group VI: Walking on 0% slope at 15% faster than self-selected speedExperimental Treatment3 Interventions

All participants will walk on a treadmill, in a straight line, on a 0% slope, at a speed that is 15% faster than their self-selected walking speed determined while walking overground.

Group VII: Walking down an 8% slope at self-selected speedExperimental Treatment3 Interventions

All participants will walk on a treadmill, in a straight line, down an 8% slope, at their self-selected walking speed determined while walking overground up an 8% slope.

Group VIII: Walking around a 2-meter diameter circle with the prosthesis on the outside of the circleExperimental Treatment3 Interventions

All participants will walk overground while following the outline of a 2-meter diameter circle, at their self-selected walking speed determined while walking around the circle, with their prosthetic limb on the outside of the circle.

Group IX: Walking around a 2-meter diameter circle with the prosthesis on the inside of the circleExperimental Treatment3 Interventions