Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

Not Applicable

Completed

• Conditions: Amputation

• Registration Number: NCT06468059
• Lead Sponsor: Little Room Innovations, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-21
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-21
• Primary Completion: 2024-07-16
• Study Completion: 2024-07-16
• Results First Submitted: 2025-08-13
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Results First Posted: 2025-09-17
• Last Update Posted: 2025-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Total Energy Stored (TES)	through study completion, an average of 1 day	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.

Secondary Outcome Measures

Name	Time	Method
Ankle Quasi-Stiffness (AQS)	through study completion, an average of 1 day	AQS is a measure of joint deformation under an applied load. It is extracted from the torque-angle relationship during walking determined through inverse dynamics. The ideal AQS varies from person to person, but in this study we were interested in seeing if the prostheses could achiever lower AQS.
Walking Speed	through study completion, an average of 1 day	This is the linear rate of change of position when a person walks, typically given in m/s.
Likert Scale Rating of Device Satisfaction	through study completion, an average of 1 day	A 1 to 10 rating of device satisfaction where the pre-trial perceived device satisfaction of the participant's prescribed ankle is defined as a 5 out of 10. 1 is defined as completely unacceptable, and 10 is defined as ideal performance.

Trial Locations

Locations (1)

Kennesaw State University; 🇺🇸 Kennesaw, Georgia, United States