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OpenTrials
Completed

NCT Number: NCT06468059

Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.

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Key information

Conditions

Amputation

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennesaw State University

Kennesaw, Georgia, 30144, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-89 years old
  • unilateral transtibial amputation
  • daily use of a low profile foot
  • cognitive ability to understand and willingness to provide informed consent and follow the study protocol

Exclusion criteria

  • unable to perform walking for 2 minutes without an assistive device
  • other health conditions which may prevent them from participating in the study

Treatment and study plan

Layered Low Profile Foot

Device

The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.

Other names: LPF

Prescribed Ankle

Device

The prescribed ankle is the prosthetic ankle that the subject wears for daily use.

Other names: Daily Use Prosthesis

Primary outcomes

  1. Total Energy Stored (TES)

    Time frame: through study completion, an average of 1 day

    TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.

Secondary outcomes

  1. Ankle Quasi-Stiffness (AQS)

    Time frame: through study completion, an average of 1 day

    AQS is a measure of joint deformation under an applied load. It is extracted from the torque-angle relationship during walking determined through inverse dynamics. The ideal AQS varies from person to person, but in this study we were interested in seeing if the prostheses could achiever lower AQS.

  2. Walking Speed

    Time frame: through study completion, an average of 1 day

    This is the linear rate of change of position when a person walks, typically given in m/s.

  3. Likert Scale Rating of Device Satisfaction

    Time frame: through study completion, an average of 1 day

    A 1 to 10 rating of device satisfaction where the pre-trial perceived device satisfaction of the participant's prescribed ankle is defined as a 5 out of 10. 1 is defined as completely unacceptable, and 10 is defined as ideal performance.

Sponsors and collaborators

Lead sponsor

Little Room Innovations, LLC

Industry

Collaborators

  • Kennesaw State University

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2024
Registry last updated
Sep 17, 2025

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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