RecruitingPhase 1NCT07263945

Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes


Sponsor

University of Colorado, Denver

Enrollment

60 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot, a medical device called A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot, and others for people with amputation, bone anchored devices, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAs-prescribed prosthetic foot stiffness

Each participant will complete a motion capture collection, tests of physical function, and sensory tests in their currently prescribed prosthetic foot.

DEVICEA prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot

Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories stiffer than their currently prescribed prosthetic foot.

DEVICEA prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot

Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories softer than their currently prescribed prosthetic foot.


Locations(1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

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NCT07263945


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