Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

June 12, 2024 updated by: Little Room Innovations, LLC
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Kennesaw, Georgia, United States, 30144
        • Kennesaw State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-89 years old
  2. unilateral transtibial amputation
  3. daily use of a low profile foot
  4. cognitive ability to understand and willingness to provide informed consent and follow the study protocol

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Layered Low Profile Foot (LPF) vs. Prescribed Ankle
In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.
Device: Layered Low Profile Foot
The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.
Other Names:
  • LPF
Device: Prescribed Ankle
The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
Other Names:
  • Daily Use Prosthesis
Experimental: Prescribed Ankle vs. Layered Low Profile Foot (LPF)
In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.
Device: Layered Low Profile Foot
The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.
Other Names:
  • LPF
Device: Prescribed Ankle
The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
Other Names:
  • Daily Use Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 day
Ankle Range of Motion (ROM)
Time Frame: through study completion, an average of 1 day
ROM is the difference between the maximum and minimum ankle angles measured in a gait cycle.
through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 day
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.
through study completion, an average of 1 day
Rollover Shape from Motion Capture
Time Frame: through study completion, an average of 1 day
Rollover shape is a physical shape that is kinematically equivalent to the contact points of a deformable shape moving through a given loading pattern. Rollover shape is measured by combining the readings of a force plate with the kinematic data obtain from motion capture.
through study completion, an average of 1 day
Device Satisfaction survey of the Orthotics and Prosthetics Users Survey (OPUS)
Time Frame: through study completion, an average of 1 day
The OPUS is a self-report questionnaire for determining quality, maintaining awareness of improvement in activities, evaluating changes in functional status, and assessing satisfaction with devices and services. Scores on the questionnaire range from Strongly Agree to Strongly Disagree. Strongly Agree is associated with the best outcomes in the survey.
through study completion, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Little Room Innovations, LLC

Collaborators

Kennesaw State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • R43HD110316 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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