Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

NCT06468059 | Completed Results FDA Device

• 1 other identifier: R43HD110316
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total Energy Stored (TES)

  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

Secondary Outcomes (3)

• Ankle Quasi-Stiffness (AQS)

  through study completion, an average of 1 day

• Walking Speed

  through study completion, an average of 1 day

• Likert Scale Rating of Device Satisfaction

  through study completion, an average of 1 day

Study Arms (2)

Layered Low Profile Foot (LPF) vs. Prescribed Ankle

EXPERIMENTAL

In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.

Device: Layered Low Profile Foot; Device: Prescribed Ankle

Prescribed Ankle vs. Layered Low Profile Foot (LPF)

EXPERIMENTAL

In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.

Device: Layered Low Profile Foot; Device: Prescribed Ankle

Interventions

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.

Also known as: LPF

Layered Low Profile Foot (LPF) vs. Prescribed Ankle; Prescribed Ankle vs. Layered Low Profile Foot (LPF)

Prescribed Ankle DEVICE

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

Also known as: Daily Use Prosthesis

Layered Low Profile Foot (LPF) vs. Prescribed Ankle; Prescribed Ankle vs. Layered Low Profile Foot (LPF)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Little Room Innovations, LLC: lead
• Kennesaw State University: collaborator

Study Sites (1)

Kennesaw State University

Kennesaw, Georgia, 30144, United States

Location

Results Point of Contact

• Title: Mark Geil
• Organization: Kennesaw State University

mgeil@kennesaw.edu

(470) 578-4805

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control prosthesis and the experimental prosthesis are covered by a sock to prevent the participant from knowing which has been fit.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 21, 2024
• Study Start: March 21, 2024
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-09

Locations

US (1)