Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

Little Room Innovations, LLC

Status: Completed

Conditions: Amputation

Treatments: Device: Prescribed Ankle; Device: Layered Low Profile Foot

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06468059

R43HD110316 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Layered Low Profile Foot (LPF) vs. Prescribed Ankle

Experimental group

Description:

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

Treatment:

Device: Layered Low Profile Foot

Device: Prescribed Ankle

Prescribed Ankle vs. Layered Low Profile Foot (LPF)

Experimental group

Description:

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

Treatment:

Device: Layered Low Profile Foot

Device: Prescribed Ankle