An interventional study of Powered Prosthesis and Prescribed Prosthesis in Amputation, sponsored by Massachusetts Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Massachusetts Institute of Technology · Not applicable, Interventional, and Device feasibility
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.
In summary there will be 3 cohorts in this study, 1) a group of subjects that have an osseointegrated fixture with implanted electrodes, 2) a group that does not have implanted electrodes, and 3) non-amputee healthy control group to serve as a baseline comparison. In summary, the groups will be asked to wear a number of non-invasive sensors and the amputee groups will use a powered ankle prosthesis in place of their customary prosthesis. Data will be collected from various wearable sensors and other motion-capture devices as the subjects walk. At certain points during the study, the control settings of the powered prosthesis will be adjusted, either manually or automatically. Trials will also be conducted with the subjects prescribed prosthesis.
Massachusetts Institute of Technology is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
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The patient must have adequate socket to support the device.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Powered Prosthesis
The subject will be undergo the same experiments with their prescribed ankle prosthesis to act as a comparison to the standard of care.
Device: Prescribed 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. It is motorized to provide positive power during walking.
Subject's prescribed prosthesis
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.
Time frame: Multiple sessions across 1-2 weeks
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.
Time frame: Multiple sessions across 1-2 weeks
Plan to share: No — Data may contain identifying information.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Sep 2030, 59 months after the start.
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Massachusetts Institute of Technology