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Completed

NCT Number: NCT07159490

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

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Standard-of-care prosthetic foot

Device

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

Other names: Sierra, Freedom Innovations

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

Device

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

Other names: Sierra, Freedom Innovations

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

Device

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

Other names: Sierra, Freedom Innovations

Dual keel prosthetic foot

Device

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

Other names: Thrive, Freedom Innovations

Powered ankle-foot

Device

A powered prosthetic ankle-foot.

Other names: Empower, Otto Bock

Primary outcomes

  1. Vertical Ground Reaction Force Impulse (Normalized)

    Time frame: During study visit (approximately 3 hours)

    A measure of body support. Normalized by body mass, including the mass of the load when applicable.

  2. Anterior Ground Reaction Force Impulse (Normalized)

    Time frame: During study visit (approximately 3 hours)

    A measure of body forward propulsion. Normalized by body mass, including the mass of the load when applicable.

  3. Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)

    Time frame: During study visit (approximately 3 hours)

    A measure of balance control primarily for anterior and posterior added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and [gravity*body height]^0.5 (m/s) resulting in a unitless number.

  4. Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)

    Time frame: During study visit (approximately 3 hours)

    A measure of balance control primarily for intact-side added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and [gravity*body height]^0.5 (m/s) resulting in a unitless number.

  5. Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)

    Time frame: During study visit (approximately 3 hours)

    Positive ankle joint mechanical work over the prosthetic limb gait cycle is a measure of propulsion capability. A prosthetic foot with greater propulsion capability may enhance gait efficiency during everyday ambulation. Normalized to body mass and the added load mass when applicable.

Sponsors and collaborators

Lead sponsor

VA Puget Sound Health Care System

Fed

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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