Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

The goal of this clinical trial is to identify prosthesis stiffness that optimizes balance control in individuals with below knee amputations. The main question this clinical trial will answer is: • Is there an optimal stiffness that improves balance control for specific ambulatory activities and users? Participants will wear a novel prosthesis assembled with three prosthetic feet with a range of stiffness levels: each individual's clinically-prescribed foot stiffness and ± two stiffness categories. While wearing the study prostheses, participants will perform nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain).

NCT Number	NCT06711588
Lead Sponsor	Seattle Institute for Biomedical and Clinical Research Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Lower Limb Amputation Below Knee
Enrollment	21 participants
Start Date	2024-12-19
Primary Completion	2026-07-24 (estimated)
Study Completion	2026-07-24 (estimated)
Updated on ClinicalTrials.gov	2026-08-07