Powered Ankle Prosthesis for Amputation
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 who have had a below-the-knee amputation on one leg, can walk at different speeds using a prosthesis (K3 level or higher), and have a socket that fits the device.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Practice and Adjustment
Participants are given time to practice using the powered ankle prosthesis and adjustments are made to the control settings
Experimental Sessions
Participants undergo experiments using both the powered and prescribed prostheses, with data collected from wearable sensors and motion-capture devices
Follow-up
Participants are monitored for safety and effectiveness after the experimental sessions
What Are the Treatments Tested in This Trial?
Interventions
- Powered Ankle Prosthesis
Trial Overview
The study compares a new powered ankle prosthesis—controlled by nerve signals and skin stimulation—to each participant's usual prosthetic leg. It looks at walking ability, stability, and how natural the device feels.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The subject will be provided with a powered ankle prosthesis to attach in place of their customary prosthesis. This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. The subject will be given as much time as necessary to practice using the prosthesis before the experiments begin.
The subject will be undergo the same experiments with their prescribed ankle prosthesis to act as a comparison to the standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Institute of Technology
Lead Sponsor
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