Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2024-07-16

Brief Summary

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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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Detailed Description

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Conditions

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Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

The control prosthesis and the experimental prosthesis are covered by a sock to prevent the participant from knowing which has been fit.

Study Groups

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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.

Group Type EXPERIMENTAL

Layered Low Profile Foot

Intervention Type DEVICE

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

Prescribed Ankle

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Layered Low Profile Foot

Intervention Type DEVICE

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

Prescribed Ankle

Intervention Type DEVICE

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

Interventions

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Layered Low Profile Foot

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

Intervention Type DEVICE

Prescribed Ankle

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

Intervention Type DEVICE

Other Intervention Names

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LPF Daily Use Prosthesis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No