Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2025-10-01

Brief Summary

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The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads.

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Detailed Description

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The natural lower limbs provide important biomechanical functions such as body weight support, forward propulsion, and balance control during ambulation. When the loads borne by the lower limbs change, lower limb muscle activation responds accordingly to enable seamless continuation of biomechanical function. These loads can change suddenly, such as when carrying an infant, toddler, or other load like a heavy backpack. For individuals with a lower limb amputation, these sudden changes to weight-bearing loads can be problematic because they can negatively impact walking performance. One reason walking performance may suffer is that the properties of most prosthetic limbs, such as their stiffness, are constant and do not change to suit varying load conditions. Another reason is that the most widely prescribed prosthetic feet do not have motors, sensors, or brain-like controllers that act to replace the neuromuscular system of the amputated limb. Regardless of the reason, no evidence exists to guide prescription practice for veterans who walk with a prosthesis and experience sudden load changes.

The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads. The investigators will conduct a human subject experiment with help of twenty individuals with below-knee amputations. Study participants will walk on a treadmill with no added load and four added load conditions using a weighted pack (13.6 kg or \~30 lbs) to simulate an infant, toddler, or other load. The four conditions include the pack strapped to their front, their back, and carried with their arms on the intact limb side and the prosthetic limb side. Each participant will wear a usual prosthetic foot, this same foot with a heel-stiffening wedge, the same prosthetic foot but one category stiffness higher, a new-to-market dual keel prosthetic foot intended for load carrying situations, and a powered ankle foot prosthesis. The results from these experiments will aid clinicians in specifying the best prosthesis for individuals with lower limb amputations who frequently carry infants, toddlers, or other loads.

For individuals who wear a lower limb prosthesis while carrying infants, toddlers, or other loads, this research will provide evidence to support prosthesis prescription practice that reduces undesirable compensatory responses to load carriage. The objective is to help clinicians select among currently available solutions to enable individuals with lower limb loss to achieve their life and work goals.

Conditions

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Amputation Prosthesis User

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This study will employ a within-subject experimental design. Each participant will wear, in randomized order, a standard-of-care prosthetic foot, this same prosthetic foot with a heel-stiffening wedge, this same prosthetic foot but one category stiffer, a dual keel prosthetic foot intended for load carriage applications, and a powered ankle-foot purported to adapt to changing loads. All study prostheses are commercially available. Each participant, wearing each of the study prostheses, will walk overground with no added load and four added load conditions of 13.6 kg: anterior, posterior, intact-side carry, and prosthetic-side carry. The load condition will be presented in block randomized order.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

A sock and foot cover to blind the participants to the study prostheses when possible (use of the powered ankle-foot will be obvious).

Study Groups

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No added load

Study participants will walk with no added load.

Group Type EXPERIMENTAL

Standard-of-care prosthetic foot

Intervention Type DEVICE

Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.

Standard-of-care prosthetic foot with heel-stiffening wedge

Intervention Type DEVICE

Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.

Standard-of-care prosthetic foot of one category greater stiffness

Intervention Type DEVICE

Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.

Dual keel prosthetic foot

Intervention Type DEVICE

A prosthetic foot with two forefoot keels intended for load carriage applications.

Powered ankle-foot

Intervention Type DEVICE

A powered prosthetic ankle-foot.

Anterior added load

Study participants will walk with 13.6 kg (30 lbs) of added load on their anterior side.

Group Type EXPERIMENTAL

Standard-of-care prosthetic foot

Intervention Type DEVICE

Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.

Standard-of-care prosthetic foot with heel-stiffening wedge

Intervention Type DEVICE

Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.

Standard-of-care prosthetic foot of one category greater stiffness

Intervention Type DEVICE

Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.

Dual keel prosthetic foot

Intervention Type DEVICE

A prosthetic foot with two forefoot keels intended for load carriage applications.

Powered ankle-foot

Intervention Type DEVICE

A powered prosthetic ankle-foot.

Posterior added load

Study participants will walk with 13.6 kg (30 lbs) of added load on their posterior side.

Group Type EXPERIMENTAL

Standard-of-care prosthetic foot

Intervention Type DEVICE

Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.

Standard-of-care prosthetic foot with heel-stiffening wedge

Intervention Type DEVICE

Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.

Standard-of-care prosthetic foot of one category greater stiffness

Intervention Type DEVICE

Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.

Dual keel prosthetic foot

Intervention Type DEVICE

A prosthetic foot with two forefoot keels intended for load carriage applications.

Powered ankle-foot

Intervention Type DEVICE

A powered prosthetic ankle-foot.

Intact-side added load

Study participants will walk with 13.6 kg (30 lbs) of added load on their intact side.

Group Type EXPERIMENTAL

Standard-of-care prosthetic foot

Intervention Type DEVICE

Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.

Standard-of-care prosthetic foot with heel-stiffening wedge

Intervention Type DEVICE

Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.

Standard-of-care prosthetic foot of one category greater stiffness

Intervention Type DEVICE

Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.

Dual keel prosthetic foot

Intervention Type DEVICE

A prosthetic foot with two forefoot keels intended for load carriage applications.

Powered ankle-foot

Intervention Type DEVICE

A powered prosthetic ankle-foot.

Prosthetic-side added load

Study participants will walk with 13.6 kg (30 lbs) of added load on their prosthetic side.

Group Type EXPERIMENTAL

Standard-of-care prosthetic foot

Intervention Type DEVICE

Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.

Standard-of-care prosthetic foot with heel-stiffening wedge

Intervention Type DEVICE

Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.

Standard-of-care prosthetic foot of one category greater stiffness

Intervention Type DEVICE

Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.

Dual keel prosthetic foot

Intervention Type DEVICE

A prosthetic foot with two forefoot keels intended for load carriage applications.

Powered ankle-foot

Intervention Type DEVICE

A powered prosthetic ankle-foot.

Interventions

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Standard-of-care prosthetic foot

Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.

Intervention Type DEVICE

Standard-of-care prosthetic foot with heel-stiffening wedge

Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.

Intervention Type DEVICE

Standard-of-care prosthetic foot of one category greater stiffness

Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.

Intervention Type DEVICE

Dual keel prosthetic foot

A prosthetic foot with two forefoot keels intended for load carriage applications.

Intervention Type DEVICE

Powered ankle-foot

A powered prosthetic ankle-foot.

Intervention Type DEVICE

Other Intervention Names

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Sierra, Freedom Innovations Sierra, Freedom Innovations Sierra, Freedom Innovations Thrive, Freedom Innovations Empower, Otto Bock

Eligibility Criteria

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Inclusion Criteria

1. Unilateral transtibial amputee
2. Have been fitted with and used a prosthesis for at least six months
3. Do not use heel stiffening wedges or bumpers in their as-prescribed prosthesis
4. Wear their prosthesis for at least four hours per day
5. Are moderately active by self-report
6. Can be fitted with the study prostheses (prosthetic foot size, stiffness category and build heights)

Exclusion Criteria

1. Do not have a proper fit and suspension and one cannot be achieved with clinical resources
2. Presence of disorder, pain, or injury other than amputation that interferes with gait

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No