NCT06468059

Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Little Room Innovations, LLC · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-03-21
• Primary completion: 2024-07-16
• Completion: 2024-07-16
• First posted: 2024-06-21
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study