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Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis
Sponsor: University of Washington
Summary
People with lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation in daily activities, despite using prostheses. The purpose of this randomized clinical trial is to advance understanding of how dynamic foot design features may help people with LEA This study will include people with above-knee amputations, or with bilateral amputations, or with below-knee amputations and lower levels of mobility. The main study questions/goals are: 1a) To determine if frontal plane adaptation in a foot prosthesis impacts performance, comfort, activities of daily living, and community mobility in the study populations. To answer this question, we will compare a locked and unlocked version of the novel prosthesis. 1b) To determine how the unlocked investigational foot condition compares to the person's usual foot using the outcomes listed above. 2\) To examine the participants' lived experience during community activities. The study will use performance tests, questionnaires, logbooks, and interviews to monitor person-centered outcomes and perceptions of personal functioning during the use of the investigational foot (locked and unlocked) compared to the person's usual foot.
Official title: The Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis for People With Above-Knee Amputations, Bilateral Amputations, or Limited Mobility
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2023-09-01
Completion Date
2027-04
Last Updated
2024-05-23
Healthy Volunteers
No
Conditions
Interventions
META-Arc foot locked
Participants are provided with the META-Arc from WIllowWood Global, and a locking mechanism prevents side-to-side motion.
META-Arc foot unlocked
Participants are provided with the META-Arc from WIllowWood Global allowing side-to-side motion.
Locations (3)
University of South Florida
Tampa, Florida, United States
WillowWood Global
Mount Sterling, Ohio, United States
University of Washington
Seattle, Washington, United States