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RECRUITING
NCT06214026
NA

Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

Sponsor: University of Washington

View on ClinicalTrials.gov

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

DEVICE

META-Arc foot locked

Participants are provided with the META-Arc from WIllowWood Global, and a locking mechanism prevents side-to-side motion.

DEVICE

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