Seattle Institute for Biomedical and Clinical Research
The goal of this clinical trial is to determine if automatic stiffness modulation improves balance control in ambulatory individuals with below-knee amputations in real-world conditions. The main question this clinical trial will answer is: • Can a user-specific automatic stiffness prosthesis improve balance control compared to user's fixed stiffness prosthesis that was clinically prescribed? Participants will perform free-ranging ambulatory activities outside the laboratory that include nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain) while wearing, in random order, 1) a fixed stiffness prosthesis that was clinically prescribed and 2) an automatic stiffness prosthesis that uses an open source ankle configured to implement a user- and activity-specific automatic stiffness modulation control scheme intended to improve balance control.
Individuals with lower limb amputations are at higher risk of falling compared to able-bodied and other clinical populations and are more likely to sustain life-altering injuries. The higher fall risk is primarily due to the loss of muscles crossing the ankle, which are critical to maintaining balance control. Prosthetic devices are designed to provide appropriate stiffness for needed stability and support. While research has shown the optimal stiffness to maintain balance varies across ambulatory activities (e.g., straight walking versus turning), most clinically prescribed prosthetic devices…
Inclusion Criteria: * 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 * Able to walk on a treadmill Exclusion Criteria: * 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.)
The participant's clinically prescribed prosthesis whose stiffness category is determined by the person's body weight and activity level (standard clinical practice).
A novel prosthesis whose user-specific and activity-specific stiffness profile is automatically modulated based on their ambulatory activity.
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