About this trial
The purpose of this study is to evaluate the performance of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or Female age 18-70. The patient must have a unilateral transtibial amputation . The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
Disqualifiers
Women who are pregnant. Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).
Trial design
Single group
Treatments tested in this trial
Powered Prosthesis
DeviceThis powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. It is motorized to provide positive power during walking.
Prescribed Prosthesis
DeviceSubject's prescribed prosthesis
Treatment groups
Trial outcomes
Primary outcomes
Kinematic Measures of Lower-Limb Biomechanics
Quantitative analysis of lower-limb kinematics (joint angles in degrees) during level-ground walking, stair navigation, and other functional tasks.
Kinetic Measures of Lower-Limb Biomechanics
Quantitative analysis of kinetic biomechanics including ground reaction and joint forces (Newtons) during level-ground walking, stair navigation, and other functional tasks.
Sponsors and contacts
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