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Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

NCT06468059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-09-17

Study results available
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Summary

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.

Conditions

  • Amputation

Interventions

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.

DEVICE

Prescribed Ankle

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

Sponsors & Collaborators

  • Kennesaw State University

    collaborator OTHER

  • Little Room Innovations, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2024-07-16
Completion
2024-07-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468059 on ClinicalTrials.gov