Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
- Conditions
- Amputation
- Interventions
- Device: Layered Low Profile FootDevice: Prescribed Ankle
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- unable to perform walking for 2 minutes without an assistive device
- other health conditions which may prevent them from participating in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Prescribed Ankle vs. Layered Low Profile Foot (LPF) Prescribed Ankle In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF. Layered Low Profile Foot (LPF) vs. Prescribed Ankle Layered Low Profile Foot In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle. Layered Low Profile Foot (LPF) vs. Prescribed Ankle Prescribed Ankle In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle. Prescribed Ankle vs. Layered Low Profile Foot (LPF) Layered Low Profile Foot In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.
- 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.
Ankle Range of Motion (ROM) through study completion, an average of 1 day ROM is the difference between the maximum and minimum ankle angles measured in a gait cycle.
- 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.
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.
Rollover Shape from Motion Capture through study completion, an average of 1 day 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.
Device Satisfaction survey of the Orthotics and Prosthetics Users Survey (OPUS) through study completion, an average of 1 day 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.
Trial Locations
- Locations (1)
Kennesaw State University
🇺🇸Kennesaw, Georgia, United States