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.
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.)
Crossover
Fixed stiffness prosthesis
DeviceThe participant's clinically prescribed prosthesis whose stiffness category is determined by the person's body weight and activity level (standard clinical practice).
Automatic stiffness prosthesis
DeviceA novel prosthesis whose user-specific and activity-specific stiffness profile is automatically modulated based on their ambulatory activity.
Peak-to-peak range of the frontal plane whole-body angular momentum
Frontal plane whole-body angular momentum is a measure of the extent to which a person will rotate in the frontal plane in the absence of an external force or torque. The peak-to-peak range quantifies how much this metric varies and is used to describe a person's balance.
Prosthetic Limb Users Survey of Mobility
The Prosthetic Limb Users Survey of Mobility is a self-report instrument designed to measure the mobility of adults with lower limb amputations, utilizing a set of calibrated questions to assess perceived mobility in various activities. The Prosthetic Limb Users Survey of Mobility has been recommended by the National Institute of Child Health and Human Development as a core Common Data Element for lower-limb loss research as outcome measures to assess mobility.
Activities-Specific Balance Confidence Scale
The Activities-Specific Balance Confidence Scale is a 16-item self-report questionnaire that measures an individual's confidence in performing daily activities without losing balance or feeling unsteady. It is widely used to identify individuals at risk of falls and to guide interventions aimed at improving balance and mobility. The Activities-Specific Balance Confidence Scale has been recommended by National Institute of Child Health and Human Development as a core Common Data Element for lower-limb loss research as an outcome measure to assess balance.
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Seattle Institute for Biomedical and Clinical Research
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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