N/A N=6 Randomized Single-blind Basic Science

Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

Amputation

Bottom Line

View on ClinicalTrials.gov: NCT06468059 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: Total Energy Stored (TES) — 20.1; 13.3 Joules

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Layered Low Profile Foot (Device); Prescribed Ankle (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Little Room Innovations, LLC
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Energy Stored (TES)	20.1; 13.3	—
SECONDARY Ankle Quasi-Stiffness (AQS)	9.8; 9.3	—
SECONDARY Walking Speed	1.27; 1.28	—
SECONDARY Likert Scale Rating of Device Satisfaction	4.3; 5.2	—

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.

Eligibility Criteria

Inclusion Criteria

18-89 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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06468059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.