Study of a New Adjustable Foot Prosthesis Compared to Usual Prosthetic Feet in People With Above-Knee, Bilateral, or Lower Mobility Amputations

What this Trial Is About

Researchers are investigating how a new type of prosthetic foot with adaptable side-to-side motion might help people with lower limb amputations. This study focuses on individuals with above-knee amputations, bilateral amputations, or below-knee amputations who have limited mobility. The trial aims to better understand how this dynamic foot design affects balance, pain, daily activities, mobility, and user satisfaction compared to traditional prosthetic feet. The study uses a randomized crossover design where participants try both a locked and an unlocked version of the META-Arc foot prosthesis. The locked version prevents side-to-side ankle movement, while the unlocked version allows it. Participants will also use their usual prosthetic foot at different times during the study. The trial follows an A1-B1-B2-A2 sequence, with about two weeks spent using each prosthetic condition and several visits for assessments. Participants will take part in walking tests such as the 10-Meter Walk, Timed Up and Go, Figure-of-8 Walk, and Four-square Step Test, as well as complete questionnaires and daily logbooks about their prosthetic use, pain, and activities. Semi-structured interviews will explore their experiences with each foot. Data will be collected online or on paper, and researchers will measure mobility, comfort, function, and community participation over roughly 10 weeks of study involvement.

Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis