Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

Amputation Clinical Trial

Official title:

Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06468059
• Other study ID #: R43HD110316
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Little Room Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

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

Locations

Country	Name	City	State
United States	Kennesaw State University	Kennesaw	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Little Room Innovations, LLC	Kennesaw State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Energy Stored (TES)	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.	through study completion, an average of 1 day
Primary	Ankle Range of Motion (ROM)	ROM is the difference between the maximum and minimum ankle angles measured in a gait cycle.	through study completion, an average of 1 day
Secondary	Ankle Quasi-Stiffness (AQS)	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.	through study completion, an average of 1 day
Secondary	Walking Speed	This is the linear rate of change of position when a person walks, typically given in m/s.	through study completion, an average of 1 day
Secondary	Rollover Shape from Motion Capture	Rollover shape is a physical shape that is kinematically equivalent to the contact points of a deformable shape moving through a given loading pattern. Rollover shape is measured by combining the readings of a force plate with the kinematic data obtain from motion capture.	through study completion, an average of 1 day
Secondary	Device Satisfaction survey of the Orthotics and Prosthetics Users Survey (OPUS)	The OPUS is a self-report questionnaire for determining quality, maintaining awareness of improvement in activities, evaluating changes in functional status, and assessing satisfaction with devices and services. Scores on the questionnaire range from Strongly Agree to Strongly Disagree. Strongly Agree is associated with the best outcomes in the survey.	through study completion, an average of 1 day