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).
Unilateral transtibial (below-knee) amputation
Been fit with a prosthesis and used it for at least 6 months
Wear the prosthesis for 4 or more hours on average per day
Be at least one-year post-amputation
Presence of disorder, pain, or injury other than amputation that interferes with gait
Current skin irritation or injury on residual limb
Use of an assistive device for walking (cane, walker, etc.)
9
Treatment groupsSee each treatment group below.
Seattle Institute for Biomedical and Clinical Research
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator