Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- Little Room Innovations, LLC
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Total Energy Stored (TES)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Total Energy Stored (TES)
Time Frame: 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 Outcomes
- Ankle Quasi-Stiffness (AQS)(through study completion, an average of 1 day)
- Walking Speed(through study completion, an average of 1 day)
- Likert Scale Rating of Device Satisfaction(through study completion, an average of 1 day)